Emerging Tests: Medicare to Cover Next Gen-Sequencing Tests for Advanced Cancer

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...]


FDA Watch: Personalized Medicine Approvals Continue to Flow

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...]


Industry Buzz: ACLA Goes for Kill in PAMA Lab Fees Challenge Case

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...]


FDA Watch: Off-Label Marketing Rule Put Back on Ice & Extra Comment Time for CLIA Waiver Proposals

For the second time in less than a year, the FDA indefinitely delayed a controversial rule expanding its authority to regulate off-label marketing, i.e., promotion of medical products for additional … [Read more...]


The Year in Dx VC Investment: Dx/Tools Outperforms Health Care & Liquid Biopsy/AI/ Informatics Outperforms Dx/Tools

In a year that witnessed venture capital health care investment reaching an all-time high, diagnostics/tools (Dx/Tools) companies made out particularly well, according to Silicon Valley Banks' … [Read more...]


Genetic Profiling: Study Casts Doubt on Cost-Effectiveness of Leading Breast Cancer Recurrence Assay

Among the many genetic profiling assays entering the commercial market, few have been more successful than Genomic Heath's Oncotype DX, which is now covered by most of the nation's biggest insurers. … [Read more...]


FDA Watch: Greenlights for NGS Tumor Panels May Augur New Approach to LDT Approvals—Both Product & Pathway

A pair of tumor tests highlights the list of new FDA approvals from mid-November through December, including: FoundationOne's CDx (F1CDx) companion diagnostic test for solid tumors; and Memorial … [Read more...]


LDTs: Top 10 New FDA Diagnostic Approvals of 2017

The phrase "most exciting FDA laboratory developed test approvals of the year" is no longer an oxymoron. The agency remains glacial in tempo, jealous of its authority and suspicious of the industry it … [Read more...]


Industry Buzz: 2017-The Year in DX Mergers & Acquisitions

Meh. That word best describes the state of 2017 merger and acquisition activity in the clinical laboratory space, where firms continue to prefer alliance to absorption at a rate of over 3 to 1. But … [Read more...]


CMS Finalizes Controversial PAMA Fee Schedule

It's official. CMS is going forward with its controversial 2018 PAMA Clinical Laboratory Fee Schedule (CLFS). Regrettably, the final version closely tracks the preliminary one (See GCA, Oct. 24, 2017, … [Read more...]