AACC

The guidelines are the first to attempt to specify which drugs are appropriate to test for routinely, guideline authors say.

Theranos CEO Elizabeth Holmes speaks at the AACC 2016 meeting

At the American Association for Clinical Chemistry meeting, Theranos CEO Elizabeth Holmes said her company is working on third-party review and publications of the firm's technologies and tests.

The draft guidance has created anxiety among clinical laboratory managers, who worry about how FDA will define LDTs, among other concerns.

The lightweight, mobile device was highlighted in an oral presentation at AACC today. 

Gene panel testing of cancer patients helps clinicians identify actionable mutations, according to presenters at this year's AACC meeting.

A Hermes Pardini Institute researcher described how a gene panel test for breast cancer uncovered variants of unknown significance and how new data changed their significance.

The Xpert Omni platform will launch in 2016 running Cepheid test cartridges on a compact battery-operated device that is anticipated to cost less than $3,000.

NEW YORK (GenomeWeb) – Before the US Food and Drug Administration's draft guidance on laboratory-developed tests (LDTs) can be finalized, the agency will need to iron out with industry players several areas of regulation that remain unclear and confront old issues around the agency's authority ov

CHICAGO (GenomeWeb) — Seegene this week plans to submit its first molecular diagnostic test for US Food and Drug Administration clearance, an assay for herpes simplex virus I and II that uses the company's TOCE primer technology for multiplexed real-time PCR.

LOS ANGELES (GenomeWeb News) – Life Technologies plans to follow its purchase of Navigenics with several "small, tuck-in acquisitions" over the next few months as part of a broad strategy to build its molecular diagnostics business, Ronnie Andrews, president of medical sciences at the company, sa

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A federal grand jury has indicted Elizabeth Holmes and Ramesh Balwani for alleged wire fraud in conjunction with their activities at Theranos.

Nature News reports that some developers are nervous about GitHub's acquisition by Microsoft.

A direct-to-consumer genetic testing company sent out used spit kits, CNBC reports.

In PLOS this week: comparison of commercial bisulfite kits, new method to predict essential proteins, and more