Avantect Pancreatic Cancer Test Receives CPT Code and Preliminary Payment Determination from the Centers for Medicare and Medicaid Services (CMS)

ClearNote Health™ has unveiled that the American Medical Association (AMA) has granted a new Current Procedural Terminology (CPT®) Proprietary Laboratory Analyses (PLA) code for the Avantect™ Pancreatic Cancer Test, thereby paving the way for increased patient access and broader adoption of its test. The new code, 0410U (Oncology (pancreatic), DNA, whole genome sequencing with 5-hydroxymethylcytosine enrichment, whole blood or plasma, algorithm reported as cancer detected or not detected), set to become effective on October 1, 2023.
The Avantect™ test has been specifically designed for patients at elevated risk for pancreatic cancer. This includes individuals recently diagnosed with Type 2 diabetes who are over the age of 50 and those with a family history of pancreatic cancer. Patients newly diagnosed with Type 2 diabetes are almost eight times more likely to develop pancreatic cancer. Additionally patients with a first degree relative with pancreatic cancer are 3-5x more likely to develop the disease.
CMS has revealed preliminary reimbursement rate determinations for the new and revised CPT codes recently issued by the AMA, and proposed a recommended reimbursement rate of $1,160. CMS is anticipated to release its final determination regarding the rate for 0410U later this year. The final rates, as established by CMS, will officially take effect on January 1, 2024.
Dave Mullarkey, Chief Executive Officer of ClearNote Health, emphasized the significance of these recent milestones, stating, “Receiving a CPT code and CMS preliminary rate recommendation mark important milestones for our organization and will expand patient access to early detection of pancreatic cancer.”
The company’s test uses proprietary epigenomic methods that utilize a standard blood draw to identify pancreatic cancer signals at its earliest stages. These methods rely on measuring levels of the 5-hydroxymethylcytosine (5hmC) in cell-free DNA. In a clinical validation study using a blind and independent dataset consisting of 2150 subjects (102 with pancreatic cancer and 2048 without), the PaC detection test demonstrated a sensitivity of 68.3% for early-stage disease (stage I/II), with an overall sensitivity of 66.7%. The test also exhibited a high specificity of 96.9%.