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FDA submission

The company's test kit can ID pathogenic organisms and provide a measure of antibiotic susceptibility directly from positive blood culture samples.

The company's test kit provides identification and antimicrobial susceptibility testing of pathogens for patients suspected of bacteremia or fungemia.

During a conference call to discuss the firm's fourth quarter and full year 2015 earnings, company officials discussed their plans for 2016.

The molecular diagnostic test detects Shiga toxin-producing E. coli and the serotype O157 directly from a patient specimen. 

The draft guidance has created anxiety among clinical laboratory managers, who worry about how FDA will define LDTs, among other concerns.

The firm expects to receive both FDA clearance and CE-IVD marking for the system and assay by the end of 2015 and has more assays in development.

Ventana is providing ALK testing for clinical trials studying both Novartis' Zykadia and Genentech's alectinib.

The Ventana ALK (D5F3) CDx Assay is designed to identify ALK1-positive lung cancer patients who may benefit from targeted therapy. 

NEW YORK (GenomeWeb) – Thermo Fisher Scientific today said that it has completed the listing of the Ion PGM Dx next-generation sequencing system with the US Food and Drug Administration as a Class II medical device.

NEW YORK (GenomeWeb) – Epigenomics today said that its second quarter revenues rose 18 percent year over year.
The company's revenues for the three months ended June 30 reached €405,000 ($541,000), compared to €343,000 in Q2 2013.

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23andMe and Airbnb have partnered to offer "heritage travel," according to Venture Beat.

China may include regulations protecting genes and embryos in its update of its civil code, Nature News reports.

In Nature this week: exome sequence analysis of individuals with type 2 diabetes, genomic prediction of maize yield across environments, and more.

NPR reports on efforts to engineer bacteriophages to destroy antibiotic-resistance bacteria.