DX Deals

Siemens, California Health Network and Biopharm Research Company Partner for Enhanced Liver Fibrosis Testing

Although COVID-19 remains the driving force, non-pandemic-related strategic deal making continues. Among the most impactful deals announced in December is the partnership among Renown Institute for … [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...]

DX Earnings Report

Q3 Creates the Perfect Storm of Sustained COVID-19 Tailwinds and Diminishing Headwinds

July through September 2020 was a remarkable quarter for most diagnostics firms. In fact, it was the closest thing to a perfect storm for earnings. Pandemic tailwinds drove massive revenues for firms … [Read more...]

Business Trends

Labs Partner with Airlines to Offer COVID-19 Testing to Travelers

civCOVID-19 has greatly complicated air travel from country to country and even state to state. While entrance rules vary from place to place, a number of jurisdictions are allowing travelers to avoid … [Read more...]

Diagnostics Deals

JetBlue Partners with Vault Health to Offer Travelers At-Home COVID-19 Testing

COVID-19 has greatly complicated air travel from country to country and even state to state. While entrance rules vary from place to place, a number of jurisdictions are allowing travelers to avoid … [Read more...]

Market Trends

COVID-19 Fuels Massive & Sustainable Growth in Molecular Diagnostics

While it may be decimating demand for most lab tests, COVID-19 is driving incredible growth in molecular testing. The global market for molecular diagnostics will top $13 billion in 2020, about $5 … [Read more...]

Labs In Court

Magnolia Wins Round One of False Advertising Suit against Rival Collection Device Maker

Case: Score one, maybe two, for Magnolia Medical Technologies, Inc. in its ongoing litigation war with rival blood and bodily fluid collection device maker Kurin, Inc. In addition to patent … [Read more...]

Diagnostics Deals

3M and MIT Team Up to Create Rapid, Scalable SARS-CoV-2 Antigen Test

Unlike reverse transcription-polymerase chain reaction (PCR) and blood-based serology antibody assays, antigen tests are relatively inexpensive to produce and generate results rapidly at the point of … [Read more...]

LDTs

FDA Cracks Down on Improper Marketing of SARS-CoV-2 Antibody Tests

Bloated and unsubstantiated marketing claims about the capabilities of unproven serologic SARS-CoV-2 antibody tests have been a problem almost since the public health emergency began. After playing … [Read more...]

FDA Watch

First Warning Letters Issued for Improper Marketing of SARS-CoV-2 Antibody Tests

No more Mr. Nice Guy. For the first time, the FDA has exercised its enforcement powers to crack down on makers of unproven serologic SARS-CoV-2 antibody tests. A 180⁰ Pivot When the public … [Read more...]


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