On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four key takeaways for IVD test makers and labs: 1. No … [Read more...]
DOJ
Industry Buzz: Criminal Charges May Spell the End for Theranos
August 1, 2018
Four years ago, Theranos was a $10 billion company poised to turn a breakthrough blood testing technology into a diagnostics dynamo to the tune of $70 billion in annual sales. Today, the company and … [Read more...]
INDUSTRY BUZZ
FDA Watch: Agency Offers a Modicum of Relief on DTC Marketing of Genetic Tests
July 3, 2018
Last November, the FDA raised eyebrows with a notice for public comment proposing to make it easier to bring new genetic health risk (GHR) assessment tests to market. The message to GHR test … [Read more...]
HEALTH INSURANCE
Industry Buzz: LabCorp and Quest Swept Up in Insurance Contract Partner Swap
June 26, 2018
Can you imagine Scarlett and Rhett swapping partners with Romeo and Juliet? Something like the laboratory industry equivalent of that scenario took place on May 25 when two of the nation's largest … [Read more...]
ACCREDITATION
Top of the News: ANDE Rapid DNA Platform First to Win FBI Approval
June 25, 2018
"Great news! The FBI just called." --Extremely rare phrase almost never uttered except sarcastically One of the very few exceptions to the above principle is ANDE (previously known as NetBio), a … [Read more...]
GENOMICS
Market Trends: Genetic Testing Becoming a Hot New Employee Benefit
June 5, 2018
While its clinical utility remains subject to debate, genetic testing has proven its value as an employment recruitment tool, especially on the West Coast where technology firms are leveraging its … [Read more...]
INDUSTRY BUZZ
FDA Watch: Why the New NGS Guidance May Be a Paper Tiger
May 28, 2018
Last month, the FDA finalized a pair of guidance documents designed to liberalize and speed up approval of new next-generation sequencing (NGS) in vitro diagnostic (IVD) tests and devices. (See LIR, … [Read more...]
INDUSTRY BUZZ
Market Report: 2018 Shaping Up as Record Year for Healthcare Industry Mergers & Acquisitions
May 7, 2018
While healthcare industry merger and acquisition activity has been on the rise for several years, the early returns suggest that 2018 will be the biggest M&A year in over a decade. According to … [Read more...]
NEW PRODUCTS
FDA Watch: Agency Issues New Guidance to Ease Approval of NGS Tests & IVD Devices
April 30, 2018
April 13 was a red letter day for FDA guidance with the agency issuing a pair of final guidances on the design, development and validation of next-generation sequencing (NGS) tests, as well as a draft … [Read more...]
NEW PRODUCTS
FDA Watch: 23andMe Continues to Spearhead Direct-to-Consumer Marketing of LDT Genetic Tests
April 23, 2018
On March 6, the FDA announced its first ever approval of a direct-to-consumer breast cancer gene test—23andMe's genetic health risk report for detecting BRCA1 and BRCA2 genetic mutations most commonly … [Read more...]
