TOP OF THE NEWS

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...]

INNOVATION

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...]

PAMA

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—Sequencing.com (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...]

PRECISION MEDICINE

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...]

EMERGING TESTS

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

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...]

FUNDING

FDA Speeding Approval Process, Continued User Fees Needed

The U.S. Food and Drug Administration (FDA) is plagued with chronic understaffing, scrutiny over the length of time for approvals, and an expanding workload, while also facing potential budget cuts … [Read more...]

PRECISION MEDICINE

Genomic Markers May ID Risk of Chemo Side Effects

While much attention is focused on using genomic markers to target the effectiveness of treatments, simultaneous research is exploring use of genomic markers to identify patients at higher risk of … [Read more...]

PRECISION MEDICINE

Genomics May Predict Cancer Treatment Side Effects

While much attention is focused on using genomic markers to target the effectiveness of treatments, simultaneous research is exploring use of genomic markers to identify patients at higher risk of … [Read more...]


(-0000g2)