SAFETY

Diagnostic danger in the lab: Time to reform how we process orders

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...]

NEW PRODUCTS

FDA Watch: 23andMe Continues to Spearhead Direct-to-Consumer Marketing of LDT Genetic Tests

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...]

MARKETING

Theranos & Its CEO Settle Stock Fraud Charges with SEC

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

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

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

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...]

INDUSTRY BUZZ

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...]

RESEARCH

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...]

INDUSTRY BUZZ

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...]

INDUSTRY BUZZ

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...]


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