AACC

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The draft guidance has created anxiety among clinical laboratory managers, who worry about how FDA will define LDTs, among other concerns.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NEW YORK (GenomeWeb) – Before the US Food and Drug Administration's draft guidance on laboratory-developed tests (LDTs) can be finalized, the agency will need to iron out with industry players several areas of regulation that remain unclear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

LOS ANGELES – The age of genomic medicine is within "striking distance," Eric Green, director of the National Human Genome Research Institute, told attendees of the American Association of Clinical Chemistry's annual meeting here on Sunday.

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Gene drives might run into biological resistance, the Economist reports.

Forensic experts exhumed painter Salvador Dalí's body to collect DNA for a paternity test, CBS News reports.

Yale Environment 360 writes that synthetic and conservation biologists aren't always on the same wavelength, but they are trying to reach an understanding.

In Science this week: full CRISPR locus integration complex structure, and more.