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Sep 16, 2019

Liquid Biopsy Uncovers Drug Resistance Mechanisms in GI Cancer Missed by Tissue Biopsy

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The researchers believe that combining liquid and tissue biopsy can improve diagnostic and therapeutic options for cancer patients with acquired drug resistance mutations.

Jan 18, 2018

AACC Drug Testing Guidelines Take Steps Toward Reducing Excessive Drug Panel Testing

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

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The draft guidance has created anxiety among clinical laboratory managers, who worry about how FDA will define LDTs, among other concerns.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

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The Scan

Test Evaluations

UK Royal Statistical Society is organizing a working group to develop guidelines for assessing COVID-19 tests, the Guardian reports.

Justification for Stricter Standards Sought

The Washington Post reports that the White House chief of staff has asked the US Food and Drug Administration to justify the stricter standards it is seeking for a coronavirus vaccine.

Concerns Over Comment

President Donald Trump's "good genes" comment raises eugenics concerns, CNN reports.

PLOS Papers on Tremor Condition, Medical Plant Populations, Brewing Yeast Transcriptomics

In PLOS this week: genetic analysis of tremor condition, analysis of a West and Central African tree used in traditional medicine, and more.

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