INDUSTRY BUZZ

FDA Watch: First Zika Assay Gets Green Light for Marketing

Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did something it had never done before: It … [Read more...]

NEW PRODUCTS

The Dx Pipeline: A Roundup of the Month’s Key New Product Launches

Here's a summary of the key product launches from late May through the third week of June, 2019: NEWLY LAUNCHED PRODUCTS & SERVICES Company(ies) Product(s)/Service(s) Abbott Afinion … [Read more...]

INDUSTRY BUZZ

FDA Watch: Agency Approves New STD Screening Assay Applications

The FDA broke new ground by clearing a pair of STD screening assays for detecting chlamydia and gonorrhea for use with extragenital specimens, specifically from the throat and rectum. The tests, … [Read more...]

SAFETY

Business Trends: Commercial Testing Companies ‘Sell’ Health Screenings

Several companies market an array of preventive tests directly to consumers. Are these companies and tests legit? What does the medical community have to say about such companies and advertising … [Read more...]

NEW PRODUCTS

The Dx Pipeline: A Roundup of the Month’s Key New Product Launches

Here's a summary of the key product launches from late April to late May, 2019: NEWLY LAUNCHED PRODUCTS & SERVICES Company(ies) Product(s)/Service(s) Biocept Target Selector NGS … [Read more...]

DIAGNOSTIC DEALS

Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month

The end of April through mid-May was another busy period for deal making. Here's a quick overview of activity and key deals. Mergers & Acquisitions and Asset Sales Thermo Fisher Scientific's … [Read more...]

DIAGNOSTIC DEALS

Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month

The pace of diagnostic deal making picked up from the end of March through mid-April. Here's a quick overview of the activity and key deals made during the period. Mergers & Acquisitions and … [Read more...]

NEW PRODUCTS

The Dx Pipeline: A Roundup of the Month’s Key New Product Launches

Qiagen was the most active firm of the period with a trio of new product launches, including the US launch of Therascreen FGFR RGQ RT-PCR Kit as a companion diagnostic for Janssen Pharmaceutical's … [Read more...]

INDUSTRY BUZZ

FDA Watch: New Warning Letter May Signal Resurgence of LDT Enforcement Activity

After a couple of years of dormancy, the FDA laboratory developed test (LDT) enforcement volcano stirred on April 4, when the agency issued a warning letter to Inova Genomics Laboratory (Inova) for … [Read more...]

NEW PRODUCTS

The Dx Pipeline: A Roundup of the Month’s Key New Product Launches

March was the most intense month of the year so far for new diagnostic products highlighted by 23andMe's launch of a new genetic Health Predisposition report assessing a consumer's risks of developing … [Read more...]


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