SAN DIEGO — Sept. 26, 2024 — ClearNote Health, an early cancer detection company focused on enabling people at risk for high-mortality cancers to live longer, healthier lives, today announced the American Medical Association (AMA) has issued a new Current Procedural Terminology (CPT) Proprietary Laboratory Analyses (PLA) code for the Avantect Ovarian Cancer Test. Effective October 1, 2024, the new CPT code, 0507U, establishes a reimbursement pathway for increased patient access and broader test adoption. The Avantect test is intended for patients at high risk for ovarian cancer, such as those with a genetic predisposed risk such as BRCA1, BRCA2, a family history of ovarian cancer, or a personal history of breast cancer before age 40.
In addition, CMS announced that it has proposed preliminary reimbursement rate determinations for new and revised CPT codes issued by the American Medical Association (AMA), including 0507U for the Avantect Ovarian Cancer Detection Test. ClearNote Health aligned with CMS on their reimbursement recommendation of $1,160.00. This rate was established by CMS the previous year for the Avantect Pancreatic Cancer Test which is currently reimbursed on the existing Clinical Laboratory Fee Schedule under CPT code 0410U. CMS is expected to issue a final determination on the rate for 0507U later this year. Final rates established by CMS for the clinical laboratory fee schedule will be effective on January 1, 2025.
“Receiving a CPT code and CMS preliminary rate recommendation for our Avantect Ovarian Cancer Test represents the second time ClearNote Health has reached a critical commercial and reimbursement milestone for our organization in less than 12 months, and most importantly, expands patient access to the early detection for ovarian cancer,” said Dave Mullarkey, CEO of ClearNote Health. “Ovarian cancer is the deadliest gynecological cancer and the fifth leading cause of cancer-related deaths among women. Four out of five women are diagnosed with advanced disease which is unacceptable when detection in stage 1 could increase five-year survival to over 90 percent or more.”
ClearNote Health aims to directly address the unmet need for early disease detection in high-risk patients. Its proprietary epigenomic and genomic methods use a standard blood draw to identify ovarian cancer signals at its earliest stages by measuring levels of the 5-hydroxymethylcytosine (5hmC), copy number variants and fragment sizes in cell-free DNA.
About ClearNote Health
ClearNote Health is a cancer detection company focused on enabling people at risk for high-mortality cancers to live longer healthier lives. Utilizing a standard blood draw, the company applies its proprietary epigenomic platform, combining biology and artificial intelligence, to identify DNA-based changes as cancer develops. With lead programs in non-invasive early detection of pancreatic and ovarian cancers in patients at the highest risk for these diseases, ClearNote Health identifies cancers before they progress and when patients are most likely to benefit from treatment. ClearNote Health is headquartered in San Diego, with additional presence in the San Francisco Bay area and internationally. The company’s CLIA- and CAP-accredited laboratory is located in San Diego, Calif. For more information, visit www.clearnotehealth.com or follow the company on X or LinkedIn. To learn more about the Avantect Ovarian Cancer Test, visit the test website.
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