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FDA

The new approval will allow the use of Qiagen's Therascreen EGFR RGQ PCR Kit as a companion diagnostic for Pfizer's Vizimpro in NSCLC patients.

The US Department of Health and Human Services is reviewing human fetal tissue research, according to ScienceInsider.

The agency has been gathering stakeholder input on how to regulate sequencing-based infectious disease diagnostics, including targeted and metagenomic approaches.

An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.

Policy's Effect

An FDA official says a policy limiting the hiring of foreign researchers is affecting the agency's ability to draw new employees, Stat News reports.

The firm reported a 69 percent increase in product sales, driven by a 102 percent jump in cartridge sales and jump in research revenues.  

The move is precipitated by CMS's decision to grant national coverage to NGS companion diagnostics when they're approved by the FDA.

The approval includes the use of either tumor tissue or plasma and follows previous approvals with Genentech's Tarceva (erlotinib) and AstraZeneca's Tagrisso (osimertinib).

The US National Institutes of Health and the Food and Drug Administration have proposed changing gene therapy oversight, the Associated Press reports.

At his FDA Law Blog, Jeffrey Gibbs discusses FDA's technical assistance for the draft Diagnostic Accuracy and Innovation Act.

Pages

According to New Scientist, GEDmatch changed its terms and conditions over the weekend to opt its users out of law enforcement searches.

The Atlantic looks into time spent pursuing gene leads generated through candidate gene studies.

A twin study uncovers evidence that genes may influence whether someone gets a dog, Martha Stewart reports.

In PNAS this week: Cdx2 cells can help regenerate heart tissue in mice following a heart attack, PIWI-interacting small RNA levels in human cancer, and more.