New York State Department of Health

The New York State Clinical Laboratory Evaluation Program has approved the company's FoundationACT blood-based circulating tumor DNA assay.

The firm said it will offer 25 million units consisting of common stock and common warrants at $.40 per unit. 

The company's Acuitas test provides information on the presence of 10 MDRO resistance genes in a single sample.

The tests were previously available in New York state on a patient-by-patient basis through a non-permitted laboratory testing program.

The tests are all based on the company's dual-capture, dual-sequencing platform method.

The company also announced that it has received New York State Department of Health conditional approval for three women's health molecular diagnostic tests.

Guardant said Guardant360 is the first liquid biopsy permitted by New York's CLEP, and the approval means the test can be ordered in all 50 states. 

The New York State Department of Health had previously provided conditional approval of the microRNA classifier for diagnosing indeterminate thyroid cancer cases.

The firm has received approval for two unspecified clinical tests, with a permit under the molecular genetic testing category.

The company is now able to perform testing on specimens from New York without an additional permit application process.