The San Diego-based company began marketing its first product, a portable Covid-19 test, after receiving an emergency use authorization last year. Now, it’s filing the initial paperwork to go public as it scales up manufacturing.
Often overshadowed by its larger, more affluent neighbors to the west, Imperial County had few testing and vaccination resources early on. Now, flush with vaccines, groups in the county are taking targeted efforts to reach vulnerable communities.
Cue Health, a startup that won a big government contract for its at-home Covid-19 test, recently raised $235 million in funding. The startup plans to use the funds to grow and offer additional types of tests.
Ellume, a startup that won a $232 million contract to manufacture more of its over-the-counter Covid-19 tests in the U.S., has started building a manufacturing facility in Maryland. In the longer term, it plans to use the site to prepare for future outbreaks and pandemics.
After the Food and Drug Administration authorized a swathe of over-the-counter tests for Covid-19, pharmacies are preparing to stock their shelves. But at $20 to $100 a pop, will enough people use them to make a difference?
The Food and Drug Administration gave an emergency use authorization to two more over-the-counter Covid-19 tests that can be used without a prescription. They include Abbott’s BinaxNow test and an at-home test developed by Quidel Corp.
As the Biden Administration pushes to offer more over-the-counter Covid-19 tests, the Food and Drug Administration authorized the first molecular Covid-19 test for over-the counter use. The test was developed by San Diego-based startup Cue Health.
A new CMS rule would require insurers to cover Covid-19 tests, even for asymptomatic patients. It builds on previous legislation requiring payers to cover the cost of both testing and vaccines for their members.
After Everlywell received an emergency use authorization last year from the FDA for its at-home collection kit, the agency gave Everlywell the green light to sell its test kits without requiring a prescription.
After completely exiting the ACA exchanges in 2018, CVS plan to re-enter them in 2022. Last year, enrollment through federal exchanges increased, and Aetna CEO Karen Lynch said the markets have stabilized.
Shots: Rhinostics plans to register the P&G polypropylene nasal swab as a Class I Exempt medical device and will pursue Emergency Use Authorization for home collection with rPT-PCR testing for detection of SARS-CoV-2 infection Rhinostics Standard Nasal Swab is a polypropylene collection device developed in partnership with P&G for COVID-19 testing which provides sample concentration …
In an unusual move, the Food and Drug Administration issued an alert about false negatives in startup Curative’s Covid-19 test. The test was being used by the County of Los Angeles, as well as Congress.
The company, which got started in genomic testing, has quickly expanded its services to include providing Covid-19 testing at businesses and universities. With the new funding, it plans to build infrastructure for more preventive health services.