New York State Department of Health

KidneyIntelX can be used to report risk assessment results for fast-progressing kidney disease and future kidney failure for patients with chronic kidney disease.

The first year's pilot phase aimed to develop an infectious disease digital health and precision medicine platform connecting healthcare facilities to NYSDOH.

Under the NYSDOH's approach, labs need to provide validation data within 15 days of starting to test instead of having to pursue an EUA with the FDA.

The GenFlex is a sample-to-result molecular diagnostic platform that includes sample collection, processing, amplification, and detection, the company said.

The company's +RNAinsight test, a combined DNA and RNA genetic test for hereditary cancer syndromes, was launched in October.

The assay is based on the company's AmpiProbe technology, which uses fluorescent reporter-labeled primers and quencher-labeled primers to amplify DNA.

Temple City, California-based Fulgent offers genetic tests for a range of diseases and disorders, as well as custom panels and sequencing services.

The regulatory approval means that the assay for minimal residual disease is available to monitor B cell blood cancers in patients in all 50 states.