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...]
SAFETY
Diagnostic danger in the lab: Time to reform how we process orders
April 16, 2018
By Oleg Bess, M.D. bio I don't know about you, but I was stunned by the findings from a recent report published by Coverys, a national liability insurer, which I feel should put the entire … [Read more...]
MARKETING
Theranos & Its CEO Settle Stock Fraud Charges with SEC
April 4, 2018
Seven years ago, Theranos was a $9 billion dynamo seemingly on the precipice of blowing the blood testing market wide open. Today, the company and its CEO and founder, Elizabeth Holmes, are a … [Read more...]
COVERAGE
Emerging Tests: Medicare to Cover Next Gen-Sequencing Tests for Advanced Cancer
March 26, 2018
In the PAMA era, there are two salient trends in Medicare Part B lab reimbursements: Sharply lower prices for traditional tests; and Wider coverage of newly emerging tests, including some that … [Read more...]
INDUSTRY BUZZ
FDA Watch: Personalized Medicine Approvals Continue to Flow
March 19, 2018
After a slow start to the year, new product business picked up significantly in the past four weeks. Here's a rundown of the key diagnostic product launches from mid-January through late … [Read more...]
FEE SCHEDULES
Industry Buzz: ACLA Goes for Kill in PAMA Lab Fees Challenge Case
February 26, 2018
Attorneys for the American Clinical Laboratory Association asked the federal court for summary judgment in its lawsuit challenging the legality of the new PAMA-based Medicare Part B fee schedule for … [Read more...]
