FDA clearance

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.