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Expert Q&A: Labs Must Take a Greater Role in Guiding Clinicians About Abnormal Data

By Scott Wallask | Sep 5, 2024 | 1 min read

Lee Fleisher, MD, advocates for clearer interpretation of test results by medical laboratory scientists

Two female healthcare professionals sit at a desk and discuss information on a computer screen.

At-Home Genetic Testing: The Good, The Bad, and The Ugly

By Liv Gaskill, MSc | Sep 5, 2024 | 1 min read

Direct-to-consumer (DTC) genetic testing has risen in popularity in recent years—but is it all it’s cracked up to be?

Woman using a self-test kit at home, illustrating the concept of direct-to-consumer (DTC) genetic testing.

Clinical Lab Education: The Role of Virtual Reality

By Oscelle Boye, MBiomed | Jul 22, 2024 | 1 min read

How virtual reality technologies can support clinical laboratory education efforts and what leaders should know about implementation

A tan-colored computer-generated laboratory lobby with front desk.

Lab Companies Scramble to Bring Coronavirus Detection Tests to Market

By Glenn S. Demby | Jan 30, 2020 | 1 min read

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

By Glenn S. Demby | Jan 14, 2020 | 1 min read

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Industry Buzz: The 10 Biggest DX Mergers of 2019

By Glenn S. Demby | Jan 14, 2020 | 1 min read

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 diagnostics deals that did come off in 2019.

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

By Glenn S. Demby | Dec 3, 2019 | 1 min read

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 that current screening methods that rely on detecting high levels of

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

By Glenn S. Demby | Oct 31, 2019 | 1 min read

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 guidance allowing companies to submit for simultaneous review for the clinical trial.

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

By Glenn S. Demby | Oct 21, 2019 | 1 min read

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 tests providing crucial guidance on six key issues.