Merck KGaA Acquires AmpTec to Strengthen its mRNA Capabilities for Vaccines, Treatments and Diagnostics

Shots:

  • The acquisition will integrate AmpTec’s PCR-based mRNA technology with Merck’s expertise in lipids manufacturing, providing combine offering across mRNA value chain
  • The deal will expand Merck’s capabilities to develop & manufacture mRNA for use in vaccines, treatments, and diagnostics applicable in COVID-19 and many other diseases. Additionally, AmpTech’s diagnostic business focusing on customized long RNAs and DNAs for IVDs, complements existing Merck’s portfolio
  • The addition of AmpTech’s PCR-based technology to Merck allow the companies to offer innovative technologies, products, and services, advancing life-enhancing therapies

Click here ­to­ read full press release/ article | Ref: Merck KGaA | Image: Glassdoor

The post Merck KGaA Acquires AmpTec to Strengthen its mRNA Capabilities for Vaccines, Treatments and Diagnostics first appeared on PharmaShots.

MedCity INVEST Precision Medicine spotlight: Pitch Perfect Life Science track (video)

A video from the conference spotlights startup pitches and Q&A with judges in the Life Science track of the Pitch Perfect contest.

Trial results extend add to uses for Exact Sciences test

breast cancer

The genomic test, known as Oncotype DX, can help predict whether women with certain forms of breast cancer will benefit from chemotherapy — and those who won’t. The latest trial results extend the test’s reach.

How augmented intelligence and NLP can help clinicians, researchers identify rare diseases

To help clinicians diagnose rare disease more quickly and accurately, many healthcare organizations are embracing technology solutions like natural language processing (NLP) tools that can create augmented intelligence workflows that facilitate the rapid search of unstructured clinical data from multiple data sources.

Getting the right data to doctors is next hurdle for precision medicine

dna, genomics

The future of precision medicine will come only as quickly as doctors can pick out clinically useful information from the genetic data being gathered on their patients.

What’s coming up at MedCity INVEST Precision Medicine Day 3?

dna, genomics

The final day of the conference, Friday, December 11, includes a panel on precision medicine investment trends, a look at clinical trial design innovation and the life sciences track of our Pitch Perfect startup contest. Register now!

A proliferation of genetic testing options brings new challenges

dna, genomics

In the last 20 years, access to genetic testing has expanded significant as technology has advanced. But there’s still lots of work to be done to get tests covered and make them more accessible, panelists said at a virtual conference hosted by MedCity News.

What HCPs think about COVID-19’s impact on cancer

COVID-19’s knock-on effect on cancer patients is of concern by HCPs, with delayed or decreased diagnosis seen as a key worry. CREATION.co’s Lara Meyer explores why HCPs need more support.

The COVID-19 pandemic has been mainstream headline news throughout 2020 and continues to have a profound impact on all our lives. A key concern that has emerged from the crisis is how COVID-19 will affect other areas of healthcare, particularly cancer diagnosis and treatment.

To understand what healthcare professionals (HCPs) felt about this topic, CREATION.co investigated public social media, in collaboration with Sermo’s HCP survey platform, Sermo RealTime, which provides real time access to physician insights.

We looked at conversations that HCPs were having online to provide a full picture of their concerns and needs. By designing fast surveys based on insights from the online conversation we were able to get a powerful depth of insight. For the survey we recruited oncologists from the United States, United Kingdom and Spain.

HCPs concern for decreased cancer diagnosis

During the COVID-19 pandemic, delayed or decreased cancer diagnosis was highlighted by HCPs as a key concern. Prominent industry figures, such as oncologist and ex-director of the WHO Cancer Programme Professor Karol Sikora, shared news articles and utilised their networks to raise awareness of decreased cancer diagnosis.

However, only a fraction of HCPs explained why they experienced a decrease. Knowing the “why” can help to address the specific challenges that hospitals are facing to ensure patients are receiving the care they need.

Using Sermo RealTime, we asked physicians to rank why they believe there has been a decrease in diagnosis at their hospital or practice. We discovered that cancellation of appointments by hospitals was perceived to have caused the most impact. The reason ranked as the next factor, was hospital staff being diverted to COVID-19 efforts. Understanding these reasons could help with resource allocation and impact assessments.

On social media, HCPs chose to encourage their peers to continue supporting their oncology patients during the pandemic. Again, key online influencers, such as Dr Tatiana Prowell – a well-known medical oncologist specialising in breast cancer, led a call to prioritise patients and raise awareness of decreased diagnoses. We have seen many HCPs supporting their peers online throughout the pandemic.

Uncertainty around cancer treatment

A significant part of the HCP conversation online discussed treatment of oncology patients. Physicians shared their concerns about delaying or changing treatment approaches and the impact this would have in the long term. When surveying physicians using Sermo RealTime, 79% of HCPs shared that they had delayed their patients’ treatment, while 52% of HCPs opted to change their patients’ treatment approach either by switching the drug their patient is on, or changing the administration timing or dose.

For the pharmaceutical industry, this knowledge could help teams in their communication plans to support HCPs with updated information or guidelines about treatments.

We regularly see HCPs share treatment guidelines on social media to provide support when there is confusion around new or existing treatment approaches, often creating their own guidelines when none exist.

And in our survey of physicians, 58% of respondents shared that regulatory guidelines have been their go-to source for information and advice for treatment during the COVID-19 pandemic, alongside consulting their peers. However, even HCPs’ go-to source did not always provide as much support as they would have liked, with some HCPs sharing that they are still unsure of the correct treatment for patients during the COVID-19 pandemic or for cancer patients that have COVID-19.

After surveying HCPs about how confident they were about the information and advice they have received about continuing treatment for their COVID-19 positive or negative cancer patients, 70% of physicians shared that they were “somewhat confident but consulted with their peers”, showing how important peer support is during this time.

HCPs look to the future

As COVID-19 continues to affect countries around the world, HCPs are concerned about the short-term and long-term implications the pandemic will have on patient diagnosis and care. Despite having to respond reactively day-to-day, and the focus on the here and now, the future is still on HCPs’ minds.

Dr Stephanie Graff, a breast cancer oncologist, shared her concerns about “what this might mean long term—stage at diagnosis for example”, and how to bring patients safely back to care.

When physicians in our survey were asked what some of the key concerns are for them going forward, they shared the backlog of patient cases that will need manual review and further investigations, switching to less effective or immunosuppressive treatments, and patients’ hesitancy or distress preventing them getting treatment. Others also shared the same concern as Dr Graff, that cancer patients present at a later stage because of backlogs and hesitancy to come to hospitals having a much larger impact on the treatment approach for these patients.

Across both open and closed online networks HCPs are concerned about the future of patient care.

The online HCP conversation continues at a steady rate each day with oncologists, nurses and specialists continuing to share their concerns and needs online with peers. Throughout the year, HCPs continue to seek the answers they are looking for and share resources online.

These concerns all present opportunities for pharmaceutical companies, hospitals, advocacy groups and medical organisations to support HCPs in very specific areas. Listening to the voices of HCPs online, especially as they are more active during this time, can help uncover key areas for engagement and support.

About the author

Lara MeyerAt CREATION.co, Lara supports clients in scoping and delivering projects. Her pharmaceutical experience includes laboratory research, as well as in marketing and strategy and she recently completed an MSc in Global Management from the London School of Economics. Working with CREATION.co she leads a team of insight analysts compiling reports.

The post What HCPs think about COVID-19’s impact on cancer appeared first on .

Which startups will present at MedCity INVEST Precision Medicine Pitch Perfect?

Finish line ahead

Among the areas of interest for companies presenting at Pitch Perfect at INVEST Precision Medicine are clinical stroke detection, making medical research more inclusive, using technology to accelerate the pace of clinical trials, developing more patient friendly drug delivery systems for reconstitutable drugs, and more.

Accumulated genetic variations: What they are and why they matter to a complete health picture 

Unlike inherited genetic predispositions, accumulated genetic changes are the result of environmental influences, such as smoking, chemicals or ultra-violet radiation. A growing body of research links somatic changes to an increased likelihood of blood cancers and cardiovascular disease, both heart disease and stroke.

Mark your calendars for our virtual INVEST Precision Medicine conference, December 9-11

Here’s a preview of some of the panel discussions at INVEST Precision Medicine, including diagnostics, investment trends, and building a bioinnovation hub.

AstraZeneca, Oxford are latest to unveil Covid-10 vaccine results

The partners pooled results from two trials and two different dosing regimens, one appearing to be more effective than the other. They hope to produce 3 billion doses in 2021 with an emphasis on serving poorer countries.

Important questions about Pfizer’s Covid-19 vaccine

News of positive results from Pfizer’s Covid-19 vaccine is heartening but historically, important scientific announcements about vaccines are made through peer-reviewed medical research papers that have undergone extensive scrutiny about study design, results and assumptions, not through company press releases.

String of FDA approvals gives momentum to liquid biopsies

Following years of research and investment, liquid biopsies are steadily accumulating FDA approvals. The tests are being used in molecular profiling of solid tumors and as companion diagnostics for targeted cancer therapies.

Are Handheld Ultrasound Imaging Devices a True Revolution in Diagnostic Imaging Domain?

Advancements in the field of disease diagnostics have led to development of point-of-care medical imaging devices; handheld ultrasound scanners have emerged as a novel solution to cater to unmet need in this domain. These handheld ultrasound imaging devices are the lightest portable ultrasound devices, which permit patient diagnosis from a single transducer and transmit images to either smartphones or tablets for visualization purpose.

Ultrasound Imaging Devices

Where is Innovation and What are Key Focus Areas?

In order to highlight the innovation and recent trends, I skimmed through over 100 recent news articles related to handheld ultrasound devices and plotted a would cloud from news titles. Upon closure inspection, you would see keywords such as smart, telemedicine, cost-saving, demand, FDA, approves and several others; however, one specific keyword, COVID-19, took my specific attention. There is no doubt in saying that current crisis has created a heavy demand for the diagnosis of pulmonary symptoms, and these handy devices are also being extensively used for the diagnosis of COVID-19 and related lung infections.

Ultrasound Imaging Devices a True Revolution in Diagnostic

A Deeper Dive into Current Developer Landscape

Given the huge diagnostic potential and lucrative market opportunities offered by these devices, we at Roots Analysis conducted a detailed analysis of the current market landscape of over 100 handheld ultrasound imaging devices, based on over 10 product specific parameters. Below, I have provided a glimpse of the dataset that we have prepared for this analysis:

A Deeper Dive into Current Developer Landscape

In fact, over 80% of companies developing these devices are either small-sized or mid-sized players. This can be attributed to the fact that the unmet need within the field of diagnostic imaging has spurred the establishment of many start-ups in recent years. Further, this field has witnessed contributions from several large firms, such as (in alphabetical order) Analogic, Fujifilm, GE Healthcare, Meditech Equipment, PHILIPS and Siemens Healthineers.

Can Diagnostic Imaging Industry Truly Save Billion Dollars by Adopting these Devices?

The best thing I liked about these point-of-care diagnostic imaging devices is- high image scanning efficiency per radiologist. In fact, in one of my conversation with prominent industry stakeholders, he believes that adoption of such devices could lead to about 10% enhancement in physicians’ / radiologists’ efficiency, thereby allowing them to perform more number of scans in a single day. Further, to provide an in-depth logical understanding to our clients, we have generated a detailed insights on adoption trends and likely cost-saving potential of these devices in over 45 countries.

Can Diagnostic Imaging Industry Truly Save Billion Dollars by Adopting these Devices?

How big is Overall Market for Handheld Ultrasound Imaging Devices?

To estimate the overall market opportunities, Roots Analysis has done detailed demand and market attractiveness analysis, providing answers to key questions as: how much devices are being used annually across the globe, which therapeutic area holds highest demand, which type of end-users are likely to contribute to high revenues, and most importantly, what is the short-term, mid-term and long-term impact of COVID-19 on overall market? To find answers to these key questions and to know further about the market forecast analysis, highlighting the likely growth of the global handheld ultrasound imaging devices market, for the time period 2020-2030, check out the report here.

Check out our new Reports Here-

Global Handheld Ultrasound Imaging Devices Market, 2020-2030

You may also be interested in the following titles:

  1. STING Pathway Targeting Therapeutics and Technologies
  2. Point-of-Care Diagnostics Market for Infectious Diseases by Indication
  3. Single-cell Sequencing Services and Technologies Market, 2020-2030

The post Are Handheld Ultrasound Imaging Devices a True Revolution in Diagnostic Imaging Domain? appeared first on Blog.

COVID-19 tests prop up Roche as US biosimilars bite in Q3

Roche’s pharmaceutical revenues have been hit by falling sales in its pharma division in Q3 but a spike in demand for COVID-19 tests spared the Swiss company’s blushes.

Sales of its “big three” cancer drugs were all down considerably in Q3 as cheaper biosimilars gained market share in the US.

Avastin was down 30% compared with the same quarter last year, generating revenues of just under 1.2 billion Swiss francs ($1.3 billion)

There was a similar story with MabThera/Rituxan, which was down 33% to just over CHF 1 billion ($1.1 billion) for the quarter, and Herceptin’s sales dipped 38% to CHF 879 million ($947 million).

In the past three years Roche has enjoyed one of the most successful drug launches of all time with MS drug Ocrevus, but this has not been enough to offset the falling sales from these cancer drugs which at their peak generated yearly sales in excess of $20 billion.

All three are facing competition from several different biosimilars in the US, which have come to market over the last couple of years and after the cut price competitors hit the European market.

Biosimilars are near-copies of complex biologic drugs that are shown to be as safe and effective as the originator with a series of rigorous trials and tests.

They are not sold at the rock-bottom prices seen with generics of small molecules but can save health systems billions by undercutting the price of the expensive biologics.

Sales for the pharma division slipped 4% to just over CHF 11.1 billion ($11.95 billion) for the quarter.

Surging sales from the company’s diagnostics division, which has been busy because of demand for tests during the COVID-19 pandemic, meant that sales for the group were broadly flat in the quarter.

The diagnostics division saw an 18% increase in revenues to just under CHF 3.6 billion ($3.9 billion), meaning that at constant exchange rates the company’s sales were up 1$ to CHF 14.7 billion ($15.8 billion).

Overall the company saw strong sales in the first quarter followed by a COVID-19 related decline in Q2, with sales stabilising in Q3 thanks to stronger sales of new medicines and demand for coronavirus tests.

Confirming the company’s 2020 outlook, CEO Severin Schwan noted the FDA approvals for three new medicines: Enspryng and Evrysdi for rare diseases and the cancer medicine Gavreto.

Roche is also working with Regeneron on the REGN-COV2 antibody cocktail, which the FDA is reviewing for an Emergency Use Authorization for COVID-19.

The post COVID-19 tests prop up Roche as US biosimilars bite in Q3 appeared first on .

HTA criteria used to evaluate diagnostics

When evaluating a new diagnostic, HTA agencies must assess two separate issues: analytical and clinical validity. Analytical validity basically indicates whether the test works; is it able to accurately predicts the presence or absence of a particular biomarker of interest. Clinical validity is whether the test matters in clinical practice.  It could be the case that a test perfectly predicts a biomarker, but the presence or absence of the biomarker would not have a big impact on the treatment recommended by a physician. 

Two papers in Value in Health evaluate the criteria health technology assessment (HTA) bodies use to evaluate new diagnostic tests.

Garfield et al. 2016 examines a series of case studies evaluated by Australia’s Medical Services Advisory Committee (MSAC), Canada’s CADTH, UK’s NICE and it’s Diagnostic Assessment Programme (DAP), US’s Evaluation of Genomic Applications in Practice and Prevention (EGAPP) and Palmetto’s MolDX Program, and Germany’s Institute for Quality and Efficiency in Healthcare (IQWiG).  The missions of these different HTA agencies varied:

Palmetto, for example, serves as a reimbursement gatekeeper similar to Australia’s MSAC for diagnostics, whereas NICE’s DAP assesses diagnostics in all phases of a product life cycle that could already have reimbursement.”

In the US, Medicare has authorized Palmetto GBA to develop an HTA evaluating new diagnostics.

Palmetto’s MolDX Program was implemented in 2012 and conducts HTAs on both US Food and Drug Administration-approved diagnostics and LDTs. The goals of the program are 1) focusing Medicare coverage to diagnostics that demonstrate clinical validity and utility; 2) tracking utilization for reimbursement through the implementation of unique codes for each diagnostic; 3) creating a consistent and standardized approach for making coverage and pricing decisions for diagnostics; and 4) building a body of evidence demonstrating the effectiveness of diagnostics in the real-world setting by linking specific tests with clinical decision making and patient outcomes.”

Diagnostic
companies face significant uncertainty when determining what evidence (if any)
is needed to support an HTA submission.

  1. HTA
    eligibility unclear for diagnostics
    . There is no clear mandate as to which
    diagnostics need formal HTA.  For
    instance, most in vitro diagnostics do not undergo a formal HTA
  2. HTA
    eligibility also unclear for laboratory-developed tests (LDT)
    . There is no
    uniform approach for LDTs (a.k.a. “in-house” or “home-brew” tests).  It is not clear whether they should be
    formally evaluated by HTA agencies along with regulatory-approved tests, or
    whether payers should consider them differently with regard to pricing and
    reimbursement.
  3. Evidence
    requirements unclear.
    Evidence requirements are not clearly delineated with
    no universal guidance for outcomes to be measured, appropriate study types,
    performance requirements, comparative effectiveness, and economic thresholds.
  4. Impact of
    HTA recommendations on payer decisions not clear.
      How HTA recommendations affect payer reimbursement,
    access, and pricing is also unclear and varies substantially across health care
    systems
  5. Life
    science response unclear
    .  Given the
    uncertainty above, it is not clear how diagnostic test innovators would make
    decisions about their proposed pricing

For example, the National Institute for Health and Care
Excellence (NICE)’s Diagnostic Assessment Programme (DAP) has well-defined
requirements for assessment and the submission document is not extensive.  However, “the timeline is long, taking more
than 2 years in some cases.” 

Another paper by Chen, Peirce and Marsh (2020) examines the criteria NICE’s DAP uses to evaluate new diagnostics and how cost-per-QALY estimates affect reimbursement.  This study found:

…[among] 22 evaluations, 91 decision problems were identified for further analysis, of which 52, 15, and 24 received “recommended,” “not recommended,” and “not recommended–only in research” guidance, respectively. The overall consistency rate of the DAC [Diagnostics Advisory Committee] decisions with the £20 000/QALY threshold was 73.6%. Diagnostic technologies that were not recommended, despite an ICER less than £20 000/QALY, were associated with a larger number of decision-modifying factors favoring the comparator, versus recommended diagnostic technologies with ICERs less than £20 000/QALY. For technologies with ICERs greater than £20 000/QALY, the number of decision-modifying factors was comparable for positive and negative recommendations.

Sources:

  • Garfield S, Polisena J, Spinner DS, Postulka A, Lu CY, Tiwana SK, Faulkner E, Poulios N, Zah V, Longacre M. Health technology assessment for molecular diagnostics: practices, challenges, and recommendations from the medical devices and diagnostics special interest group. Value in Health. 2016 Jul 1;19(5):577-87.
  • Chen G, Peirce V, Marsh W. Evaluation of the National Institute for Health and Care Excellence Diagnostics Assessment Program Decisions: Incremental Cost-Effectiveness Ratio Thresholds and Decision-Modifying Factors. Value in Health. 2020 Aug 18.

HTA criteria used to evaluate diagnostics

When evaluating a new diagnostic, HTA agencies must assess two separate issues: analytical and clinical validity. Analytical validity basically indicates whether the test works; is it able to accurately predicts the presence or absence of a particular biomarker of interest. Clinical validity is whether the test matters in clinical practice.  It could be the case that a test perfectly predicts a biomarker, but the presence or absence of the biomarker would not have a big impact on the treatment recommended by a physician. 

Two papers in Value in Health evaluate the criteria health technology assessment (HTA) bodies use to evaluate new diagnostic tests.

Garfield et al. 2016 examines a series of case studies evaluated by Australia’s Medical Services Advisory Committee (MSAC), Canada’s CADTH, UK’s NICE and it’s Diagnostic Assessment Programme (DAP), US’s Evaluation of Genomic Applications in Practice and Prevention (EGAPP) and Palmetto’s MolDX Program, and Germany’s Institute for Quality and Efficiency in Healthcare (IQWiG).  The missions of these different HTA agencies varied:

Palmetto, for example, serves as a reimbursement gatekeeper similar to Australia’s MSAC for diagnostics, whereas NICE’s DAP assesses diagnostics in all phases of a product life cycle that could already have reimbursement.”

In the US, Medicare has authorized Palmetto GBA to develop an HTA evaluating new diagnostics.

Palmetto’s MolDX Program was implemented in 2012 and conducts HTAs on both US Food and Drug Administration-approved diagnostics and LDTs. The goals of the program are 1) focusing Medicare coverage to diagnostics that demonstrate clinical validity and utility; 2) tracking utilization for reimbursement through the implementation of unique codes for each diagnostic; 3) creating a consistent and standardized approach for making coverage and pricing decisions for diagnostics; and 4) building a body of evidence demonstrating the effectiveness of diagnostics in the real-world setting by linking specific tests with clinical decision making and patient outcomes.”

Diagnostic
companies face significant uncertainty when determining what evidence (if any)
is needed to support an HTA submission.

  1. HTA
    eligibility unclear for diagnostics
    . There is no clear mandate as to which
    diagnostics need formal HTA.  For
    instance, most in vitro diagnostics do not undergo a formal HTA
  2. HTA
    eligibility also unclear for laboratory-developed tests (LDT)
    . There is no
    uniform approach for LDTs (a.k.a. “in-house” or “home-brew” tests).  It is not clear whether they should be
    formally evaluated by HTA agencies along with regulatory-approved tests, or
    whether payers should consider them differently with regard to pricing and
    reimbursement.
  3. Evidence
    requirements unclear.
    Evidence requirements are not clearly delineated with
    no universal guidance for outcomes to be measured, appropriate study types,
    performance requirements, comparative effectiveness, and economic thresholds.
  4. Impact of
    HTA recommendations on payer decisions not clear.
      How HTA recommendations affect payer reimbursement,
    access, and pricing is also unclear and varies substantially across health care
    systems
  5. Life
    science response unclear
    .  Given the
    uncertainty above, it is not clear how diagnostic test innovators would make
    decisions about their proposed pricing

For example, the National Institute for Health and Care
Excellence (NICE)’s Diagnostic Assessment Programme (DAP) has well-defined
requirements for assessment and the submission document is not extensive.  However, “the timeline is long, taking more
than 2 years in some cases.” 

Another paper by Chen, Peirce and Marsh (2020) examines the criteria NICE’s DAP uses to evaluate new diagnostics and how cost-per-QALY estimates affect reimbursement.  This study found:

…[among] 22 evaluations, 91 decision problems were identified for further analysis, of which 52, 15, and 24 received “recommended,” “not recommended,” and “not recommended–only in research” guidance, respectively. The overall consistency rate of the DAC [Diagnostics Advisory Committee] decisions with the £20 000/QALY threshold was 73.6%. Diagnostic technologies that were not recommended, despite an ICER less than £20 000/QALY, were associated with a larger number of decision-modifying factors favoring the comparator, versus recommended diagnostic technologies with ICERs less than £20 000/QALY. For technologies with ICERs greater than £20 000/QALY, the number of decision-modifying factors was comparable for positive and negative recommendations.

Sources:

  • Garfield S, Polisena J, Spinner DS, Postulka A, Lu CY, Tiwana SK, Faulkner E, Poulios N, Zah V, Longacre M. Health technology assessment for molecular diagnostics: practices, challenges, and recommendations from the medical devices and diagnostics special interest group. Value in Health. 2016 Jul 1;19(5):577-87.
  • Chen G, Peirce V, Marsh W. Evaluation of the National Institute for Health and Care Excellence Diagnostics Assessment Program Decisions: Incremental Cost-Effectiveness Ratio Thresholds and Decision-Modifying Factors. Value in Health. 2020 Aug 18.

Genentech Collaborates with Imbio to Develop Imaging Diagnostics for Lung Diseases

Shots:

  • The agreement leverages Imbio’s technical, regulatory & commercial expertise to build medical imaging AI technology for use in research, clinical trials & clinical practice
  • The focus of the agreement is to develop quantitative imaging diagnostics for lung diseases and to bring unique solutions for pulmonary imaging. The collaboration integrates Imbio’s expertise in imaging biomarkers with Genentech’s pulmonary disease expertise for enhancing drug development and delivering more personalized healthcare
  • Imbio will continue to develop & market its portfolio of quantitative imaging algorithms for lung & cardiothoracic diseases apart from the collaboration

    Click here ­to­ read full press release/ article | Ref: PR Newswire | Image: UT Health

The post Genentech Collaborates with Imbio to Develop Imaging Diagnostics for Lung Diseases first appeared on PharmaShots.

Roche working “around the clock” to tackle UK test supply problems

Supplies of swabs for coronavirus and other critical NHS tests for diseases like cancer, diabetes and heart disease have been threatened by a failure at a facility operated by Roche.

The company said the problems – which also include other items like reagents and screening kits – have resulted from a switch to a new warehouse, which ironically is intended to make production quicker and more efficient through the use of automated processes.

The issues have led to a significant drop in processing capacity that could impact testing for two to three weeks – just as daily cases of coronavirus in the UK are continuing to escalate with more than 14,500 new infections reported yesterday.

Roche is one of the major suppliers of testing equipment for the NHS, with most of its materials for the UK market coming from a single distribution facility in Newhaven, East Sussex.

A BBC report says that at least one NHS trust has advised doctors to ration non-urgent tests and prioritise supply of swabs for coronavirus testing, and there are concerns some essential items could be out of supply within a few days.

North Devon Healthcare NHS Trust says it is expecting a delivery of swabs next week, adding if that doesn’t materialise it will have a big impact on its ability to carry out COVID-19 testing.

In an emailed statement, Roche told us that: “We deeply regret that there has been a delay in the dispatch of some products. We are prioritising the dispatch of [coronavirus diagnostics] and antibody tests and doing everything we can to ensure there is no impact on the supply of these to the NHS.”

The company adds that since then it has “worked around the clock to prioritise and manage orders as well as increase this capacity.”

It goes on: “As well as extending working hours, we have recruited extra staff and, where they can, our dedicated teams on the ground are working with customers to distribute products and minimise service disruption.”

Antibody test order

Roche’s issues affect the supply of swab tests used to detect if someone is currently infected with SARS-CoV-2, but there was better news on the supply of antibody tests that detect whether a person has been exposed to the virus in the past.

This week the UK government signed a contract with Abingdon Health for the supply of a million AbC-19 rapid antibody tests, which use a small drop of blood from a finger-prick and deliver results in 20 minutes without the need for a specialised lab.

The government said the testing kits will be used to “help build a picture of how the virus has spread across the country and further develop our understanding of how antibodies work.”

Antibody testing was trumpeted in March as the UK’s ticket to emerge from lockdown, but that view was soon undermined by the proliferation of tests that didn’t meet regulatory guidelines.

There are three main approved blood tests for COVID-19 in the UK – from Roche, Abbott and Ortho Clinical Diagnostics – but these require a full venous blood sample rather than a fingerpick and have been in limited supply, reserved mainly for healthcare workers.

That hasn’t stopped a myriad of companies from offering fingerprick tests – including claiming to be based on these technologies – directly to the public. against Public Health England (PHE) and Medicines and Healthcare products Regulatory Agency (MHRA) guidance.

Abingdon says its test has undergone an independent evaluation commissioned by the UK government that will be published in full in due course by PHE, after peer review.

The post Roche working “around the clock” to tackle UK test supply problems appeared first on .

Roche working “around the clock” to tackle UK test supply problems

Supplies of swabs for coronavirus and other critical NHS tests for diseases like cancer, diabetes and heart disease have been threatened by a failure at a facility operated by Roche.

The company said the problems – which also include other items like reagents and screening kits – have resulted from a switch to a new warehouse, which ironically is intended to make production quicker and more efficient through the use of automated processes.

The issues have led to a significant drop in processing capacity that could impact testing for two to three weeks – just as daily cases of coronavirus in the UK are continuing to escalate with more than 14,500 new infections reported yesterday.

Roche is one of the major suppliers of testing equipment for the NHS, with most of its materials for the UK market coming from a single distribution facility in Newhaven, East Sussex.

A BBC report says that at least one NHS trust has advised doctors to ration non-urgent tests and prioritise supply of swabs for coronavirus testing, and there are concerns some essential items could be out of supply within a few days.

North Devon Healthcare NHS Trust says it is expecting a delivery of swabs next week, adding if that doesn’t materialise it will have a big impact on its ability to carry out COVID-19 testing.

In an emailed statement, Roche told us that: “We deeply regret that there has been a delay in the dispatch of some products. We are prioritising the dispatch of [coronavirus diagnostics] and antibody tests and doing everything we can to ensure there is no impact on the supply of these to the NHS.”

The company adds that since then it has “worked around the clock to prioritise and manage orders as well as increase this capacity.”

It goes on: “As well as extending working hours, we have recruited extra staff and, where they can, our dedicated teams on the ground are working with customers to distribute products and minimise service disruption.”

Antibody test order

Roche’s issues affect the supply of swab tests used to detect if someone is currently infected with SARS-CoV-2, but there was better news on the supply of antibody tests that detect whether a person has been exposed to the virus in the past.

This week the UK government signed a contract with Abingdon Health for the supply of a million AbC-19 rapid antibody tests, which use a small drop of blood from a finger-prick and deliver results in 20 minutes without the need for a specialised lab.

The government said the testing kits will be used to “help build a picture of how the virus has spread across the country and further develop our understanding of how antibodies work.”

Antibody testing was trumpeted in March as the UK’s ticket to emerge from lockdown, but that view was soon undermined by the proliferation of tests that didn’t meet regulatory guidelines.

There are three main approved blood tests for COVID-19 in the UK – from Roche, Abbott and Ortho Clinical Diagnostics – but these require a full venous blood sample rather than a fingerpick and have been in limited supply, reserved mainly for healthcare workers.

That hasn’t stopped a myriad of companies from offering fingerprick tests – including claiming to be based on these technologies – directly to the public. against Public Health England (PHE) and Medicines and Healthcare products Regulatory Agency (MHRA) guidance.

Abingdon says its test has undergone an independent evaluation commissioned by the UK government that will be published in full in due course by PHE, after peer review.

The post Roche working “around the clock” to tackle UK test supply problems appeared first on .

Foundation Medicine to launch liquid biopsy companion diagnostic following FDA approval

The company announced Wednesday the FDA approval of its liquid biopsy test, the second to win an agency nod in less than a month, saying it would launch the product on Friday. The FDA acquired the first ever liquid biopsy companion diagnostic, Guardant Health’s Guardant360 CDx, on Aug. 10.

J.P. Morgan on the state of life sciences and strategies to fuel innovation [Sponsored]

In an interview, Peter Meath, J.P. Morgan’s co-head of Healthcare and Life Sciences, Middle Market Banking & Specialized Industries, says the Covid-19 pandemic has cast a bright light on the life sciences industry with startups raising venture funding at record levels as the virus has transformed the way people usually do business in the sector. 

UK cancer mutation testing firm Biofidelity raises $12m

Cambridge, UK-based Biofidelity has raised $12 million in first-round funding for its cancer diagnosis platform, which can detect mutations quicker than current approaches like gene sequencing.

The Series A comes just a few months after Biofidelity launched with seed funding from Longwall Ventures and private backers – as well as multinational diagnostics company Agilent.

Barnaby Balmforth

Barnaby Balmforth

Biofidelity’s molecular diagnostics platform stems from work carried out by its two founders – Dr Barnaby Balmforth, who serves as the company’s chief executive, and Cameron Frayling who is on the board of directors.

Both previously worked at Cambridge-based DNA sequencing specialist Base4 Innovation, where the technology was developed.

The company says its assays can detect as little as a single molecule of mutated DNA amongst the billions of normal molecules found in a patient sample, generating “fast, affordable, easy to interpret results.”

Crucially, the assays could become an option for the 95% of cancer patients who are currently excluded from next-generation sequencing (NGS) of their DNA because of “high cost, complexity, and slow turnaround times.”

In January, Biofidelity reported the results of an Agilent-partnered study of a test for mutations associated with lung cancer. This type of testing is usually carried out on lung tissue biopsies, which is an invasive and expensive procedure with a 10% failure rate.

The UK firm has claimed a 50-fold improvement in sensitivity with its ‘one-tube’ assay compared to FDA-approved diagnostics based on PCR technology. It also matched the performance of NGS assays, but reduced the number of steps needed from 100 to just four, speeding up the process.

Biofidelity says it will use the latest cash injection to speed up the development and clinical validation of assays for treatment selection and patient monitoring in oncology, and to bring them to market as quickly as possible.

It’s focusing initially on test panels for non-small cell lung cancer (NSCLC) and colorectal cancer, both of which are associated with a number of low-frequency genetic mutations that can guide the selection of drug treatment.

Longwall Ventures and Agilent have both returned to invest in the Series A, which on this occasion was led by BlueYard Capital.

“Delivering on the promise of precision medicine to improve outcomes for cancer patients relies on clinicians being able to precisely identify actionable genetic markers,” said Balmforth.

“Our assays will enable them to make the right decisions regarding treatment and to detect when a cancer has recurred or become resistant to therapy,” he added.

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Interest in rapid Covid-19 antigen tests continues despite accuracy concerns

Earlier this month, Ohio Gov. Mike DeWine received a false-positive result from a rapid antigen test for Covid-19, raising concerns about the tests’ accuracy. The assay’s maker, Quidel, said it is investigating the case.

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Most hospital, health systems see increase in genomics, genetics vendors by 2023, report finds

The new report, from the University of Pittsburgh Medical Center’s Center for Connected Medicine, surveyed 101 representatives of hospitals and healthcare systems. Nine out of 10 respondents said they were providing genomic or genetic testing or planning to.

INVEST Pitch Perfect winner spotlight: Amplified Sciences targets early pancreatic cancer detection

Amplified Sciences emerged as the winner of the diagnostics track for the MedCity INVEST conference’s Pitch Perfect contest with PanCystPro, the test it is developing to address the problems encountered when determining whether pancreatic cysts are cancerous.

Thrive raises $257M Series B round for registration study of blood test for early cancer detection

The study design is still being finalized, and the company is thus not yet divulging too many details. However, CEO David Daly said it would be significantly larger than the previous DETECT-A, multi-center and would include both men and women.

Eli Lilly’s P-tau217 Blood Test Demonstrate High Accuracy in Diagnosis of Alzheimer’s Disease

Shots:

  • The study involved 1402 patients across 3 cohorts: a) 81 patients in Arizona (34 with AD and 47 without), b) 699 in Sweden (301 with no cognitive impairment, 178 with mild cognitive impairment, 121 with AD dementia and 99 with other neurodegenerative diseases) and c) 622 in Colombia (365 with E280A mutations and 257 noncarriers)
  • Results:  P-tau217 accurately identified AD from other neurodegenerative diseases in both 1&2 cohort while in 3rd cohort P-tau217 was elevated in mutation carriers’ blood for 20yrs.before anticipated symptom onset and was associated with memory performance, published in JAMA
  • P-tau217 is better than blood-based biomarkers or MRI but did not perform significantly better than cerebrospinal fluid- or PET-based tau biomarkers. Moreover, the test has the potential together with digital tools for checking memory performance like smartphone apps, to improve the diagnosis of AD

Click here to­ read full press release/ article | Ref: Eli Lilly | Image: PharmaShots




Who won the MedCity INVEST Pitch Perfect competition?

Question mark heap on table concept for confusion,

Healthcare startups across health services, health IT, medical devices, biopharma and diagnostics tracks took part in the week-long competition at the conference July 20-24. Here are the winners for the five tracks.

How can life science companies benefit from hiring a Professional Employer Organization? [Sponsored]

In an interview, TriNet’s Vice President of Life Sciences, Maria Abouseif, talked about the role Professional Employer Organizations play in helping life science companies navigate the COVID-19 public health crisis.

The UK Government to Launch AbC-19 Lateral Flow Free Finger-Prick Test for COVID-19

Shots:

  • UK Rapid Test Consortium’s (UK-RTC) finger prick test passes its first major trial that delivers results in 20mints. and demonstrate 98.6% accuracy in its clinical study. The AbC-19 lateral flow test is the first approved Ab test for Covid-19 in the UK that generates an instant result
  • The clinical trial involves ~300 people and was conducted by scientists at Ulster University last month. The test utilizes full-length spike protein part of the virus to capture IgG Abs as blood passes through the home test
  • The consortium is working with NHSX to develop a test-specific app and digital service that facilitate the use and reading of the test device. The test is expected to obtain regulatory approval in the next few weeks and will be launched for use in a mass screening program before the end of 2020

Click here to read full press release/ article | Ref: The Telegraph | Image: The Telegraph




Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19

Shots:

  • The US FDA has authorized Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to 4 individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples
  • Quest Diagnostic expects to deploy the technique at its laboratories in Chantilly, VA and Marlborough, Mass., by the end of next week with additional laboratories to follow
  • The company has received the FDA’s EUA for use of self-collection molecular diagnostic kit on the Hologic and Roche’s platforms, expanding use with healthcare provider supervision via telemedicine

Click here to read full press release/ article | Ref: PRNewswire | Image: Glassdoor




A special presentation from J.P. Morgan for MedCity’s INVEST conference [Sponsored]

Pamela Aldsworth, head of VC coverage and managing director at J.P. Morgan, discusses deals and dealmaking during the pandemic and how startups can survive, in a special presentation to mark MedCity News’ annual INVEST conference.

Thermo Fisher Scientific Amends its Agreement to Acquire QIAGEN

Shots:

  • Under the amended agreement, the offer price increased from $44.5 to $49/QIAGEN share in cash, representing a premium of 35% to the closing price of QIAGEN’s ordinary shares on the Frankfurt Prime Standard on Mar 2, 2020, making the latest deal value as $12.5B
  • The amendment also provides for a reduction of the minimum acceptance threshold from 75% to 66.67% of outstanding QIAGEN shares at the end acceptance period on Aug 10, 2020, with $95M reimbursement to Thermo Fisher, if the minimum acceptance threshold is not met
  • QIAGEN’s Supervisory and Managing Boards reaffirm unanimous recommendation that all shareholders accept and tender all their QIAGEN shares in the offer prior to the end of the acceptance period. The transaction is expected to be completed in H1’21

Click here to read full press release/ article | Ref: PRNewswire | Image: MPO

Related News: Thermo Fisher Scientific to Acquire QIAGEN for ~$11.5B




Glympse Bio raises more than $46M in Series B round for biosensor technology

graphic design of a liver

The company is developing biosensors, initially for NASH, that could be used in place of liver biopsy and have applicability in development of drugs for the disease.