NEW YORK – Bio-Techne said today that the Medicare Administrative Contractor (MAC) National Government Services issued a final Local Coverage Decision (LCD) for its ExoDx Prostate IntelliScore (EPI) test for men who are being considered for an initial prostate biopsy.
The decision, which enables Medicare reimbursement, is effective for tests administered on or after Dec. 1, Bio-Techne said. More than 60 million Medicare beneficiaries will be covered for the EPI test by then, the firm said.
The EPI test — a non-invasive urine-based assay that measures three RNA biomarkers — is a risk assessment tool that assists physicians with determining whether a prostate biopsy is needed when their patients present with an ambiguous PSA test result.
The test is intended for men 50 years of age and older who have an elevated prostate specific antigen (PSA) level between 2 and 10 ng/mL and who are being considered for a prostate biopsy.
Bio-Techne's Exosome Diagnostics performs the test in its CLIA, ISO, and NY-certified laboratory located in Waltham, Massachusetts. It has processed more than 30,000 of the patient tests to date, Bio-Techne said.
The company noted that its test recently received FDA Breakthrough Designation and is included in the National Comprehensive Cancer Network (NCCN) guidelines for early detection in men for both initial and repeat biopsy.
In June, Bio-Techne announced that it had received a clinical laboratory permit from the New York State Department of Health to provide its EPI test in the state. As a result, the test became available to patients in all 50 states in the US.
Bio-Techne CEO Chuck Kummeth said in a statement that receiving a final LCD from National Government Services signals the beginning of scaling its technology and that there are "many new indications to come" in using both urine and blood samples.
SVB Leerink analyst Puneet Souda said in a research note today that Bio-Techne "management believes this is a $1 [billion] market." The company believes it can see $100 million to $300 million in annual revenues over the long term, he said. However, the investment bank believes achieving that amount of revenue is "ultimately dependent" on Bio-Techne receiving FDA clearance for the test.
"With the LCD in place, [Bio-Techne] is likely to see a significant ramp in revenue from the [approximately 25,000] tests done to date in the last 18 months, with the potential to run significantly higher over the longer term," Souda said.
In afternoon trading on the Nasdaq, Bio-Techne shares were down less than 1 percent at $199.80.