Industry Buzz

Guardant Health Challenges Exact Sciences’ Leadership of Colorectal Cancer Diagnostics Market

Colorectal cancer diagnostics is a multi-billion-dollar market that, at least before the pandemic, was projected to grow at an annual rate of nearly 6 percent. In recent months, two leading firms have … [Read more...]

Industry Buzz

Myriad Genetics Puts Its Autoimmune Division Up for Sale

What a difference a pandemic makes! Last year at this time, molecular genetic testing was a fairly soft market. But the unprecedented and unexpected demand for COVID-19 diagnostics has lifted the … [Read more...]

Emerging Tests

New Collaboration Seeks to Develop Handheld Breathalyzer Test for COVID-19

A handheld, easy-to-use breathalyzer device capable of accurately detecting COVID-19 at the point of care would represent a major breakthrough in the effort to contain the spread of the virus. That … [Read more...]

Inside the Lab Industry

Abbott and Quidel Stake Out Early Claims for Leadership of SARS-CoV-2 Rapid Antigen Testing Market

What COVID-19 antigen assays lack in accuracy with regard to RT-PCR testing is offset by their speed, low cost and scalability. In the long term, these advantages make point-of-care COVID-19 antigen … [Read more...]

Industry Buzz

HHS to FDA: Resume EUA Review of COVID-19 LDTs, And Do It Fast

The controversy over FDA Emergency Use Authorization (EUA) of laboratory developed tests (LDTs) for COVID-19 is on high boil once more. A month after the agency announced it would no longer review … [Read more...]

Industry Buzz

Market for LDTs Expected to Top $17 Billion by 2025

Even as the battle over FDA regulatory control over laboratory developed tests (LDTs) intensifies, the economic stakes get bigger. The current market value for LDTs is $12 billion. But a new report … [Read more...]

Emerging Markets

After Early Skepticism, FDA Warms to At-Home Sample Collection for COVID-19 Testing

Even before the pandemic began, concerns over the marketing of fraudulent home testing kits had been a sore spot with the FDA. So, when the agency first began to roll out its liberalized clearance … [Read more...]

Industry Buzz

COVID-19 Relief Bill Leaves Labs Out in the Cold

Labs who have answered the call to mobilize beyond capacity so that people can be tested for COVID-19 can be forgiven for thinking nobody in Washington “CARES” about them. What else are they supposed … [Read more...]

FDA

FDA Watch: Agency Finalizes CLIA Waiver Guidance for New IV Devices

On Feb. 25, the FDA issued a pair of final guidances to help manufacturers seeking clearance for new in vitro diagnostic devices. Here are the highlights. CLIA Waivers The first guidance … [Read more...]

NEW PRODUCTS

FDA Watch: Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests

There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]


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