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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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The US National Institutes of Health's All of Us project awarded $4.6 million to the company Color to develop a genetic counseling resource for the program.

The Times of India reports on a pilot study that used genomic testing to determine whether patients had drug-resistant tuberculosis.

New guidelines say that more women may benefit from genetic testing for hereditary breast or ovarian cancer, according to the Los Angeles Times.

In Cell this week: small proteins identified among human microbiome, role for tumor microbes in pancreatic cancer survival, and more.