NEW YORK – Clinical Genomics announced Friday its Colvera liquid biopsy test for patients with colorectal cancer is covered under Medicare Administrative Contractor Novitas Solution's revised local coverage determination.
The liquid biopsy test detects aberrant methylation in BCAT1 and IKZF1, two genes found at a high frequency in colorectal cancer tissue. The biomarkers are associated with minimal residual disease and recurrence for patients who have been diagnosed and treated for colorectal cancer, the company said in a statement. The test can help providers manage patients undergoing follow-up testing to determine if there is residual or recurrent colorectal cancer, the company continued.
Medically necessary Colvera tests performed on or after July 1 whose claims were submitted by Clinical Genomics in New Jersey will be covered under the LCD.
Novitas' local coverage determination covers a variety of oncology biomarkers used for diagnosis, prognosis, and prediction when those biomarkers have proven clinical validity and there is uptake of specific testing into patient management. Novitas added that "physicians must be familiar enough with all specific biomarkers, which they order, such that all test results may become clinically actionable."
Healthcare providers must also show that the biomarkers will be used to help manage or treat the patient, and for combination panels for multiple biomarkers, peer-reviewed full manuscript evidence is required, Novitas said.
The MAC recently revised the LCD, adding several biomarkers for a variety of leukemias and replacing original coverage of the ThyGenX panel with the ThyGeNEXT panel upon request. Additional leukemia biomarkers were requested for acute lymphoblastic leukemia, acute myeloid leukemia, chronic lymphocytic leukemia, chronic myeloid leukemia, hairy cell leukemia, myeloproliferative diseases, prolymphocytic leukemia, and T cell large granular lymphocytic leukemia.
The revised LCD goes into effect Dec. 13.