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FDA submission

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.

The firm has expansive plans, including a possible launch of 40 different types of tests. It currently plans to launch a liver function test in the US this summer.

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. 

Upon clearance of the platform, the company will commercialize the TruDiagnosis, an IVD system for genotyping multiple genes in a DNA sample, this year.

The firm's tool uses a balloon catheter to collect cells from a targeted region of the esophagus without the need for endoscopy

Invivoscribe submitted the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.

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