NEW YORK – Consumer genetics firm Phosphorus said Monday that it has received conditional approval from the New York State Department of Health for its GeneCompass genetic test.
Covering more than 400 genes linked to inherited cancer risk, cardiovascular disease, drug metabolism, and more, the test is priced at $249 and marketed directly to consumers, although a physician is involved in approving and final ordering of the assay.
The company launched the test through its CLIA-certified lab in July, making it available to customers in states other than New York. With the new conditional approval, the assay is now orderable nationwide temporarily, pending final approval from the NYSDOH.
Under New York's laboratory test approval process, tests considered medium risk are granted conditional approval without review, provided the laboratory holds the appropriate permit category and with the department reserving the right to withhold or withdraw approval at its discretion.
A review is then required for final unconditional approval.
In a statement, Phosphorus CEO Alex Bisignano said that firm's goal is to make preventive genetic testing the norm in medicine.
"Due to vestigial structures in our healthcare system, patients are sometimes not treated for preventable conditions until they exhibit symptoms. The GeneCompass test can help physicians identify each individual's unique health risks and form a preventative management plan to live a longer and healthier life," he added.