DX Deals

Global Collaboration Seeks to Develop Game-Changing Handheld COVID-19 Breathalyzer Test

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

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...]

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...]

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...]

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...]

Emerging Tests

FDA Offers New Guidance on Validating SARS-CoV-2 Tests in “Non-Laboratory” Settings

SARS-CoV-2 testing in homes, workplaces, airports, schools, sports venues and other non-traditional diagnostic settings is likely to play an increasingly important role in the months ahead. The FDA … [Read more...]

Diagnostic Deals

Labs, Universities and Even Computer Companies Target Point-of-Care COVID-19 Test Development

The imperative to create and provide tests capable of detecting the SARS-CoV-2 virus that causes COVID-19 coronavirus continues to fuel strategic deal making. SARS-CoV-2 point-of-care tests was the … [Read more...]

LDTs

Laboratory Developed Tests: The VALID Act is Back

With all the attention commanded by the coronavirus crisis, a potentially huge development affecting the future of the lab industry has flown under the radar. What’s at stake is the issue that has … [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...]

DIAGNOSTIC DEALS

Diagnostic Deals: Urgent Need for Coronavirus Diagnostics Fuels Strategic Collaboration

Not surprisingly, teaming up for development and commercialization of coronavirus (COVID-19) detection and vaccination products was a major theme of strategic alliance making during the period. … [Read more...]


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