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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.
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.