Shares of Guardant Health (GH -6.56%) were rising 4.7% higher as of 10:54 a.m. EDT on Thursday. The gain came after the company announced that its Guardant Reveal blood test received Clinical Laboratory Evaluation Program (CLEP) approval from the New York State Department of Health in detecting and monitoring residual disease in patients with early-stage cancer.
The win in New York marked an important milestone for Guardant Health. The company launched its Guardant Reveal product earlier this year. CLEP approval will allow oncologists in the Empire State to use the liquid biopsy test in two ways: identifying high-risk patients with colorectal cancer who could benefit from adjuvant therapy and detecting cancer recurrence.
Guardant Health's opportunity for Guardant Reveal should be big. Colorectal cancer recurs in 10% to 30% of early-stage patients. There are currently over 1.5 million survivors of colorectal cancer in the country. Guardant Reveal can detect cancer recurrence months earlier than current tests and imaging by finding circulating tumor DNA in patients' blood.
Today's announcement isn't the only good news for the healthcare stock this week. On Tuesday, Guardant Health reported that the Centers for Medicare and Medicaid Services approved Advanced Diagnostic Laboratory Test (ADLT) status for the Guardant360 CDx test. This companion diagnostic product is the first liquid biopsy approved by the U.S. Food and Drug Administration for comprehensive tumor mutation profiling across all solid cancers.
Look for Guardant Reveal to continue picking up momentum in the marketplace in the coming months. However, Guardant360 will remain the biggest growth driver for Guardant Health. The company also plans to launch a next-generation tissue assay later this year that could add another commercial winner to its product lineup.