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 immunoblots detect IgM and IgG antibodies to Borrelia species, including B. hermsii, B. miyamotoi, and B. turicatae.
For the first time ever, the center is funding the development of diagnostic systems — specifically for the development of three devices to detect the infection.
The assay is based on the company's AmpiProbe technology, which uses fluorescent reporter-labeled primers and quencher-labeled primers to amplify DNA.
The firm moved closer to commercializing its lung transplant test, and it was notified by New York State that it could begin testing patient samples using its DTC celiac disease test.
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.
The latest NYS Department of Health approval expands the company's CT/NG testing to samples from multiple relevant body sites.
MSK-ACCESS sequences 129 cancer-associated genes selected from the MSK-IMPACT assay and is designed to detect gene alterations in cfDNA specimen.