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The assay is Guardant Health’s first commercially available product for clinical management of early-stage tumors and is initially focused on colorectal cancer.
The institute offers a rapid whole-genome sequencing test designed to diagnose infants and children suspected of having a rare genetic condition.
The liquid biopsy test, Colvera, detects aberrant methylation in BCAT1 and IKZF1, two genes found at a high frequency in colorectal cancer tissue.
The test, which received EUA from the US Food and Drug Administration in April, is designed to detect human IgG antibodies in serum and plasma.
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.
In a guidance, the agency described expanded policies that will enable manufacturers, local labs, and others to quickly deploy coronavirus testing.
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.
PerkinElmer is providing its recently FDA-approved test for the program, which has identified one baby, so far, as positive for DMD.
The GenFlex is a sample-to-result molecular diagnostic platform that includes sample collection, processing, amplification, and detection, the company said.