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FDA clearance

Several of the top molecular diagnostic firms presented at the JP Morgan Healthcare Conference on Monday discussing product portfolios, FDA clearances, and plans for 2018.

Companies in the life science tools and molecular diagnostics spaces provided updates on their businesses at the 36th annual JP Morgan Healthcare Conference this week in San Francisco.

The test  runs on the GeneSTAT system, and has demonstrated 100 percent sensitivity, 99.6 percent specificity, and 100 percent reproducibility. 

The approved Ventana ALK (D5F3) immunohistochemistry CDx is available for use on the Roche BenchMark XT or BenchMark Ultra IHC/ISH slide staining systems.

The agency cleared the automated qualitative IVD test last month for the detection of the toxin B gene of toxigenic Clostridium difficile.

Guardant is providing its Guardant 360 CDx test for a clinical trial of Merck's small molecule, c-Met kinase inhibitor called tepotinib.

Patients with PD-L1-expressing gastric or gastroesophageal junction tumors can now be identified for potential treatment with Keytruda using Agilent's assay.

The funding will be used to pay for clinical trials in the US that will be used as underlying evidence for FDA clearance of the test, the company said.

The PCR-based test can simultaneously detect for the Zika virus, all serotypes of the dengue virus, the chikungunya virus, the West Nile virus, and a host gene. 

The iC-System is based on on iCubate's amplicon-rescued multiplex PCR technology, which detects multiple pathogens simultaneously.

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A new analysis suggests warming, not the arrival of humans, led to the extinction of the woolly rhinoceros thousands of years ago, the Economist reports.

Chinese health officials uncovered SARS-CoV-2 viral RNA on imported frozen food, but the New York Times reports catching COVID-19 that way would be unlikely.

The UK has ordered 60 million coronavirus vaccine doses from Novavax and 30 million doses from Janssen, according to the Guardian.

In Science this week: machine learning model predicts whether ion channel mutations will cause disease, and more.