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FDA submission

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.

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

The firm beat analysts' revenue expectations for the quarter while its net loss was in line with predictions.

The firm has completed submissions for all three of its ePlex panels for diagnosis and management of bloodstream infections that can lead to sepsis.

The company is collecting validation evidence it intends to submit to the FDA next year, which will also support launch of  the test as an LDT.

It is the first of three ePlex molecular multiplex panels for the diagnosis and management of bloodstream infections that can lead to sepsis.

The company intends to use the funds to support submission of its NGS assay to the FDA, adoption of its testing by more health systems, and continued R&D.

The company said it will seek FDA approval for the assay, an expanded version of FoundationACT, as a CDx for targeted therapies and as a tumor mutation profiling assay.

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The long-running Framingham Heart Study has received a $38 million grant, according to the Boston Globe.

A Stanford University investigation finds that its researchers did not take part in He Jiankui's work to develop gene-edited infants.

Retraction Watch reports that two researchers had both a Science and a Nature paper retracted last week.

In Genome Biology this week: genomic sequencing of milkweed bug, benchmark comparison of single-cell RNA sequencing platforms, and more.