Newly Proposed PAMA Rates for 2018 Confirm Lab Industry’s Worst Fears

The Centers for Medicare and Medicaid Services' (CMS') preliminary 2018 prices for clinical laboratory tests issued under the Protecting Access to Medicare Act (PAMA) came as a big disappointment to … [Read more...]


Employment Law Update: The Weinstein Edition

By Mike O'Brien  bio Harvey Weinstein all over our news feeds Your news feed, like mine, has exploded with references to someone named Harvey Weinstein for the past few weeks. What's up? … [Read more...]


Association Representatives Say PAMA is #1 Concern for Lab Industry

In the kick-off event of G2 Intelligence's 2017 Laboratory Institute (Washington D.C.; Oct. 25-27), representatives of the biggest laboratory-related associations shared their top priorities, which … [Read more...]


Payers Turning to Automated Pre-Approval Systems for Genetic Tests

Payers are turning to automated systems for pre-approval of genetic tests as a way to contain costs and ensure proper utilization in the face of a dizzying number of news tests. UnitedHealthcare … [Read more...]


2017 Looking Good for Health Care Investment;
Diagnostic Industry Poised for Large, Future Exits

So far, 2017 is proving to be a good year for fundraising and investment in the broad health care industry, according to report by Silicon Valley Bank (SVB). There have been some big bets placed in … [Read more...]


Draft 2018 CLFS Reveals Fundamental Flaws in PAMA Reporting Exercise; Time to Take Action

By Lâle White  bio As XIFIN predicted, the PAMA reporting exercise has resulted in significant proposed laboratory fee cuts. In fact, the multi-year decrease for the top 20 laboratory tests … [Read more...]

Two App Marketplaces Ramping Up Consumer Genomics Offerings

Two personal genome app marketplaces— (San Francisco, Calif.) and Helix (San Carlos, Calif.)—are now up and running offering consumers a combined total of 55 products for purchase. While … [Read more...]


Companion Diagnostics Driving New Model for Pharma-Dx Partnerships

With a growing number of approvals for companion diagnostics, the pharmaceutical industry is taking keen interest in testing uptake and thinking about steps it can take to further drive testing. A … [Read more...]


FDA Approves First Companion Diagnostic Panel

The U.S. Food and Drug Administration (FDA) granted premarket approval to Thermo Fisher Scientific (Carlsbad, Calif.) for a nextgeneration sequencing (NGS)-based companion diagnostic that … [Read more...]


FDA Reports Progress in Advancing Regulatory Science for Diagnostics

The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the Food and Drug Administration Safety and … [Read more...]