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...]

DEALS

Industry Buzz: The 10 Biggest DX Mergers of 2019

Conspicuous by its absence from the list is the proposed $1.2 billion Illumina takeover of Pacific Biosciences which suddenly seems to be in major trouble. Here are the 10-highest value M&A … [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...]

NEW PRODUCTS

FDA Watch: New Process for Simultaneous Review IVD Tests Used in Cancer Drug Trials

Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, the FDA issued final … [Read more...]

FDA WATCH

FDA Watch: New NGS Data Guidance May Ease Antiviral Drugs & Companion Test Approvals

A new FDA Technical Specifications document (Tech Doc) lists recommendations for sponsors on use of next generation sequencing data to secure approval of new antiviral drugs and related diagnostic … [Read more...]

INDUSTRY BUZZ

Industry Buzz: Cologuard’s Wild September Ride

The month of September was a rollercoaster for a product that has in many ways become the face of the consumer genetic testing market, Exact Sciences’ Cologuard. The Growth of Cologuard The … [Read more...]

INDUSTRY BUZZ

FDA Watch: Agency Okays EIA Technology-Based Lyme Assays

Laboratory diagnosis of Lyme disease is based on detecting the presence of antibodies against Borrelia burgdorferi, the bacteria that causes the disease, in a patient's blood. Traditional testing uses … [Read more...]

HUMAN RESOURCES

Are Erratic Scheduling Practices Causing Financial Instability for Your Hourly Lab Employees?

A study reveals that for today's hourly workforce, missing a single shift comes at a steep cost. New research from WorkJam, a digital workplace platform, found that for nearly half of employees … [Read more...]

DIAGNOSTIC DEALS

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

Big picture-wise, health care industry mergers and acquisitions during the second quarter were up 7.3% from the first quarter and topped 250 deals for the eighth quarter in a row, according to … [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...]


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