Diagnostics

Illumina’s Grail buyout beats deadline, but legal and regulatory hurdles remain

In closing its Grail acquisition before U.S. and European regulators sign off, Illumina is taking a chance the deal will pass regulatory muster. It’s a potentially pricey gambit, as Illumina could face fines for its early action and there are no assurances that regulators will agree that the deal is not anticompetitive.

BCBS of Kansas City sues Covid-19 testing provider over alleged price gouging

GS Labs, a Covid-19 testing provider, has submitted over $9.2 million in claims to the insurer as a result of its grossly inflated prices, the lawsuit states. The testing company rejected the claims, saying its “prices accurately reflect the level of service” it provides.

PacBio’s $600M Omniome buyout brings together long & short of DNA sequencing

DNA sequencing company Pacific Biosciences has reached a $600 million agreement to acquire Omniome, a startup with complementary sequencing technology. The cash and stock deal comes about 18 months after antitrust concerns led PacBio and sequencing giant Illumina to terminate their tie-up.

UK study raises hopes of long COVID test within months

A diagnostic test to detect long COVID could be available within six to 12 months, following the discovery that patients with the chronic condition have distinctive antibodies in their blood.  Researchers at Imperial College London (ICL) led by Professor Danny Altmann told the BBC’s Panorama programme that they have identified a pattern of antibodies in …

UK study raises hopes of long COVID test within months Read More »

Biotech startup using AI to take guesswork out of cancer drug selection raises $70M

Xilis is developing technology that creates a living model of a patient’s tumor, then applies artificial intelligence to determine the best drug or drug combinations to treat the cancer. Clinical trials are planned to test this precision medicine approach and the biotech startup has raised $70 million to fund its research.

INVEST Precision Medicine Pitch Perfect Health IT and Life Science tracks (video)

Video from the Health IT and Life Science tracks of our Pitch Perfect contest at INVEST Precision Medicine is now available to view.  

Check out video highlights of INVEST Precision Medicine conference from pediatrics to funding trends

The INVEST Precision Medicine conference cast a spotlight on the role of children’s hospitals, biopharma companies, diagnostic companies and startups in biopharma innovation. The video recordings of the conference sessions are now available to view.

Q&A: Cleveland Clinic Innovations’ new head has his eyes trained on the future

In a wide-ranging interview, Dr. Geoff Vince, the new executive director of Cleveland Clinic Innovations, discussed his plans for how the commercialization arm will operate, the technologies he thinks will drive interest and whether the pandemic has changed approaches to innovation.

INVEST Precision Medicine Day 3: A look at the state of precision medicine, non dilutive funding

On the final day of INVEST Precision Medicine, a panel with Caris Health, CVS Health, and Intermountain Healthcare will share assessments of precision medicine’s progress and the outlook for this sector. Also, a panel will highlight non dilutive funding opportunities for startups. Register now!

Non-Invasive Diagnostics for Fibrotic Disease Market: A Step Towards Painless and Specific Detection of Fibrosis

Advances in the field of biotechnology have enabled the development of several minimally invasive / non-invasive approaches for diagnosis of fibrotic diseases which include imaging diagnostics and biomarker-based assays. Among the biomarker-based tests, liquid biopsy (based on the analysis of biofluids such as blood, urine and / or plasma), a relatively new concept, has emerged …

Non-Invasive Diagnostics for Fibrotic Disease Market: A Step Towards Painless and Specific Detection of Fibrosis Read More »

Truepill becomes a ‘triple threat’ with diagnostics

Truepill, the company operating behind-the-scenes to help digital health companies with pharmacy fulfillment and telehealth visits, has added a third feature: at home testing. CEO Umar Afridi hopes the trio of services will create a seamless experience for most people’s basic health needs.

NYC Health + Hospitals drops use of two race-based clinical assessments

The nation’s largest public health system will stop using clinical assessments for kidney function and vaginal delivery after C-sections that use race-based calculations for determining illness severity and risk. These assessments can result in people of color not receiving the diagnoses and treatments they need.

Mayo Clinic finds algorithm helped clinicians detect heart disease, as part of broader AI diagnostics push

Mayo Clinic shared results of a study showing that an AI tool developed by the system could be used to improve diagnosis of low ejection fraction, a type of heart disease. It’s part of a broader push by Mayo Clinic to commercialize AI-based diagnostic tools, starting with spinout company Anumana.

Can your typing patterns reveal if you have Alzheimer’s?

The neuroQWERTY technology can analyse people’s typing for signs of motor conditions like Parkinson’s disease – and now the team behind it is looking to expand into the notoriously-difficult area of dementia. Teresa Arroyo-Gallego tells us about the science behind the technology and how the team hopes to reshape cognitive screening.  While many disease areas …

Can your typing patterns reveal if you have Alzheimer’s? Read More »

A value framework for diagnostics in Latin America

That is the topic of a recent paper by Augustovski et al. (2021). The authors conduct a targeted literature review of previous diagnostics value frameworks in other countries. A full list of these articles is below. Then the researchers pool the criteria and created a proposed value framework. A panel of experts was then met …

A value framework for diagnostics in Latin America Read More »

MedCity Spotlight Video: How Penn Center for Innovation is combating Covid-19 [Sponsored]

As part of MedCity’s 2021 INVEST conference, Cesar de la Fuente, presidential assistant professor at the University of Pennsylvania, explains the value of the rapid low-cost diagnostic test he has developed to detect SARS-CoV-2 and how the platform technology can be deployed to detect other diseases cost-effectively.

Serimmune CEO: Leveraging the functional antibody repertoire will transform healthcare

In response to emailed questions, the CEO and CTO talk about the immune intelligence startups’ Human Immunity Map — a growing database of immune interactions that can support the development of multiplex diagnostics, vaccines and therapeutics.

Covid-19 was a lightning rod for life science deals last year. What investment trends are taking shape in 2021? [Sponsored]

Peter Meath, Co-Head of Healthcare and Life Sciences for Middle Market Commercial Banking at J.P. Morgan, is bullish that the momentum will continue, particularly with investment trends focused on pain points amplified by the Covid-19 pandemic, from diagnostics development to supply chain management.

Hologic makes a multiplex molecular testing move with $795M Mobidiag acquisition

Mobidiag offers multiplex testing, which is the ability to test for multiple pathogens from a single test sample. Hologic said the acquisition will enable the company to enter the acute care test market, which is projected to grow in a post-pandemic world.

A preview of the INVEST Precision Medicine conference June 9-11

The conference highlights the intersections of technology and life sciences through the prism of precision medicine. The topics at the conference span pediatric innovation in precision medicine, how tech companies are addressing clinical trial challenges, supply chain management, and more.

Here are the finalists for the diagnostics track of INVEST Pitch Perfect

Finalists for the diagnostics track at INVEST Pitch Perfect include tests for upper respiratory infections, breast cancer screening, in vitro cellular immunoassays, dysphagia diagnostics, and neuroscience.

Illumina’s $7.1B Grail buyout is challenged by FTC on competitive grounds

The Federal Trade Commission is opposing Illumina’s proposed $7.1 billion Grail acquisition, arguing that it will reduce competition for multi-cancer early detection tests. Illumina disagrees with the regulator’s position and will oppose the FTC’s challenge.

Roche’s $1.8B GenMark deal brings a key testing capability for Covid-19 and beyond

Roche already sells a Covid-19 diagnostic. In acquiring GenMark Diagnostics for $1.8B, Roche is adding technology that can detect SARS-CoV-2 along with multiple respiratory diseases in a single test from a single patient sample—a capability the Swiss multinational company does not currently offer.

Roche expands COVID testing portfolio with $1.8bn GenMark deal

Roche has said it will pay $1.8 billion for molecular testing company GenMark, boosting the Swiss company’s diagnostic capabilities and adding rapid COVID tests to its pandemic arsenal.  GenMark’s tests are designed to rapidly detect multiple pathogens from a single patient sample. Of particular interest at the moment are its Respiratory Pathogen Panels, which identify …

Roche expands COVID testing portfolio with $1.8bn GenMark deal Read More »

Why hospitals want CMS, FTC to examine two UnitedHealthcare policies

Two UnitedHealthcare policies have raised several concerns among providers, including that they may display anti-competitive behavior and could block patient access to certain healthcare services. The American Hospital Association is asking the FTC and CMS to review and potentially block these policies.

Nautilus Bio lines up SPAC merger and $350M in funding for proteomics R&D

Nautilus, among the biotechs developing protein analysis tools for drug discovery and diagnostics, already has a partnership with Genentech. As it prepares to go public, Nautilus aims to do for proteomics what Illumina did for genomics.

Apply to MedCity INVEST Pitch Perfect and you could meet a future investor in your business

The startup pitch contest is part of our INVEST conference, April 19-23, which will be hosted online due to the Covid-19 public health crisis. It includes five tracks for startups: biopharma, medical devices, diagnostics, health IT and health services.

Founders of molecular diagnostics company ChromaCode share ambitions for their business

ChromaCode’s founders seek to break the paradigm of limited access to the most powerful diagnostic tools by deploying inexpensive reagent kits and software using traditional PCR detection systems so physicians can initiate testing using the most informative diagnostics without having to worry about access or cost.

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 …

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

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

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

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?

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

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 …

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

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

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 …

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

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 …

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

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 …

HTA criteria used to evaluate diagnostics Read More »

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 …

HTA criteria used to evaluate diagnostics Read More »

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 …

Genentech Collaborates with Imbio to Develop Imaging Diagnostics for Lung Diseases Read More »

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 …

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

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 …

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

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 …

UK cancer mutation testing firm Biofidelity raises $12m Read More »

Why MedCity News should be your go-to advertising partner

MedCity News has the most engaged healthcare business audience in the industry. We can collaborate with you to develop customized content or provide a platform for your business to present sponsored thought leadership content highlighting from executives in healthcare and life sciences.

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 …

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

Who won the MedCity INVEST Pitch Perfect competition?

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 …

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

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 …

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

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 …

Thermo Fisher Scientific Amends its Agreement to Acquire QIAGEN Read More »

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

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.