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...]

PUBLIC HEALTH

The DX Pipeline: OraSure Subsidiary’s DNA Test Sample Collection Kit Gets FDA Greenlight

On Jan 22, Ottawa-based DNA Genotek announced that it has obtained FDA 510(k) clearance for its Oragene Dx kits for collecting saliva samples for DNA testing. According to the company, Oragene Dx is … [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...]

DIAGNOSTIC DEALS

Diagnostic Deals: Lab Corp & Quest to Continue Targeting Small and Independent Labs for Acquisition

PAMA price cuts were supposed to drive consolidation in the lab market. The expectation was that price pressures would make it impossible for smaller labs to remain independent, rendering them juicy … [Read more...]

NEW PRODUCTS

The DX Pipeline: New Invitae App Leverages Apple Watch Data for Studying Disease Genetics

Invitae’s newly launched Invitae Discover app is in many ways the perfect manifestation of where consumer-based precision medicine diagnostics is heading. The app combines health and activity data … [Read more...]

NEW PRODUCTS

FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval

Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to … [Read more...]

DIAGNOSTIC DEALS

Diagnostic Deals: Illumina/PacBio Merger Derails & Qiagen Takes Itself Out of Play

As 2019 came to a close, the biggest story in DX deal making was the pair of anticipated M&A deals that suddenly seem unlikely to happen. As a result, two major genetic testing companies will … [Read more...]


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