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
Guardant Health Challenges Exact Sciences’ Leadership of Colorectal Cancer Diagnostics Market
February 26, 2021
Industry Buzz
Myriad Genetics Puts Its Autoimmune Division Up for Sale
January 30, 2021
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
January 6, 2021
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
January 6, 2021
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
December 1, 2020
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
October 29, 2020
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
June 1, 2020
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
March 30, 2020
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
March 6, 2020
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
February 8, 2020
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...]
