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...]
NEW PRODUCTS
FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval
January 14, 2020
DEALS
Industry Buzz: The 10 Biggest DX Mergers of 2019
January 14, 2020
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
December 3, 2019
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
October 31, 2019
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
October 21, 2019
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
October 16, 2019
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
September 30, 2019
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?
September 16, 2019
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
August 29, 2019
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
August 12, 2019
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...]
