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...]

NEW PRODUCTS

The DX Pipeline: A roundup of the month’s key new product launches

The last quarter is typically the busiest of the year for new product launches and 2019 is no exception. The DX pipeline was churning at a high pace from late October to mid-November. Here’s a rundown … [Read more...]

FDA Watch: Agency Clears the Way for Approval of Blood-Based PSA Test

The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening. The reason it doesn’t directly recommend testing for all men in this age group is … [Read more...]

DIAGNOSTIC DEALS

Diagnostic Deals: The Fate of Illumina-PacBio Merger Hangs in the Balance

Will they or won’t they? The suspense continues over whether Illumina’s proposed rescue of Pacific Biosciences will actually close. The $1.2 billion cash merger, which was originally expected to close … [Read more...]

Global News: EU Delays Launch of Eudamed Database

The European Commission (EC) is delaying the launch of the European database on Medical devices (aka Eudamed) until May 2022.  Originally, manufacturers were supposed to be compliant by May 2020 with … [Read more...]


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