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FDA submission

The Ithaca, New York-based firm has submitted its molecular diagnostic instrument along with a test to detect chlamydia, gonorrhea, and trichomonas.

The test detects 20 common viruses and bacteria that cause upper respiratory infections using the firm's high-throughput, automated MDx-3000 instrument.

The test is designed to detect clinically relevant pathogens and markers of antibiotic resistance from bronchoalveolar lavage specimens.

The firm said its assay is a real-time qPCR test for the direct detection of methicillin-resistant Staphylococcus aureus DNA in nasal swabs.

The firm is developing a multipanel test and an antibiotic resistance panel to augment its recently CE marked chlamydia and gonorrhea assay.

The PCR-based test is designed to detect 47 antibiotic resistance genes in less than three hours from bacterial isolates to help guide treatment decisions.

The firm has three clinical trials in progress to validate the clinical utility of products it soon intends to submit for regulatory clearances to the FDA.

The firm's clinical service revenues were up also 51 percent, and it also announced it has signed a contract with insurer Humana.

NantHealth CEO Patrick Soon-Shiong said that the company is seeking a fast-track FDA clearance predicated on Memorial Sloan Kettering's 468-gene panel.

The test detects genomic drug resistance mutations in HIV-1 that can lead to treatment failure and is validated on the firm's automated Sentosa workflow. 

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