FDA submission | GenomeWeb

FDA submission

Thermo Fisher developed the NGS-based multi-marker assay in collaboration with Novartis and Pfizer to match lung cancer patients with targeted drugs.

Despite lower than expected NGS instrument sales, Illumina expects continued growth in the oncology market as reimbursement increases. 

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The draft guidance has created anxiety among clinical laboratory managers, who worry about how FDA will define LDTs, among other concerns.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

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In Science this week: metagenomic-based technique for determining protein structure, and more.

An academic laments the rise of narcissism in the sciences, the Guardian reports.

Outgoing FDA commissioner Robert Califf writes in an editorial that the agency can help boost innovation.

The Trump transition team has asked NIH Director Francis Collins to remain at his post, though it's unclear for how long that will be.