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Aug 01, 2016

Theranos Offers First Glimpse of Technologies, Assay Data to Critical Lab Community

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.

Jul 31, 2015

At AACC, Clinical Labs Air Concerns Regarding FDA's Draft LDT Guidance

The draft guidance has created anxiety among clinical laboratory managers, who worry about how FDA will define LDTs, among other concerns.

Jul 29, 2015

Johns Hopkins Researchers Develop Handheld Chlamydia Test Using Microfluidics, Smartphone

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

Jul 29, 2015

Sequencing-Based Gene Panels Help Diagnose, Guide Treatment, AACC Presenters Say

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

Jul 28, 2015

At AACC, Researcher Discusses Variants of Unknown Significance Found Through NGS Panel Test

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.

Jul 27, 2015

Cepheid Introduces True Point-of-Care Molecular Platform at AACC Analyst Event

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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.

Aug 06, 2014

Industry to Seek Details from FDA on Risk Classification, Implementation of LDT Regulatory Framework

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NEW YORK (GenomeWeb) – Before the US Food and Drug Administration's draft guidance on laboratory-developed tests (LDTs) can be finalized, the agency will need to iron out with industry players several areas of regulation that remain unclear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

Jul 31, 2014

Seegene Submits First MDx to FDA with More Highly Multiplexed Test to Follow in 2015

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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.

Jul 18, 2012

Life Tech to Follow Navigenics Buy With More Acquisitions as it Builds MDx Portfolio

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

Jul 16, 2012

At AACC, NHGRI's Green Lays out Vision for Genomic Medicine

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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The Scan

Mouse Fight

The Jackson Laboratory has filed a complaint accusing Nanjing University of breeding and re-selling its mouse models, the Hartford Courant reports.

Seeing the Interactions

Oxford researchers are turning to virtual reality to visualize genes and regulatory elements, Phys.org says.

This Week in Science

In Science this week: neutrophils rely on microRNA to protect against lung inflammation, and more.

For Millions

China is moving forward with plans to sequence a million citizens, the Wall Street Journal reports.

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