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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.

Drug-breakpoint updates should provide a clearer regulatory path for AST system makers but it's only one step in the fight against antimicrobial resistance, said Romney Humphries of Accelerate Diagnostics.

The fully automated, random access calprotectin assay can help clinicians differentiate irritable bowel disease from irritable bowel syndrome.

The firm said that because of the clearance laboratories in the US can perform reproductive testing using the AMH assay with some of its immunoassay systems.

Ortho said that its infectious disease menu has been expanded by clearance of the Vitros HIV test, which detects HIV-1 and HIV-2 antibodies and the p24 antigen.

Microgenics, Astute Medical, and Siemens were among the firms whose tests and/or systems were cleared by the FDA for marketing last month.

Thorne Research will receive exclusive rights to distribute and commercialize future Drawbridge Health products in the US.

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

The test uses a proprietary coating technology, which combined with nonwoven and paper techniques, eliminates the need for plastic, rendering it water-dispersible and eco-friendly.

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