TEST:

Avantect™

"ClearNote Health...announced the results of a cost-effectiveness analysis on the use of the Avantect Pancreatic Cancer test to manage new-onset diabetes (NOD) patients for their risk of developing pancreatic cancer in the first three years post diabetes diagnosis. These findings, developed in collaboration with the Mayo Clinic and the Arizona Centers for Digestive Health, will be presented on November 19 at the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) conference....The increased incidence of pancreatic cancer in patients diagnosed with diabetes has been observed repeatedly in clinical studies, in most cases less than 24 months prior to their diagnosis of pancreatic cancer. Avantect was shown to be cost-effective when used to detect early-stage pancreatic cancer in recently diagnosed diabetes patients 50 years of age or older."

"ClearNote Health...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...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....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."

"ClearNote® Health...announced it has signed an agreement to partner with the Pancreatic Cancer Early Detection (PRECEDE) Consortium. The PRECEDE Consortium is an international, multi-institutional collaborative group of experts working to improve early detection for those with a heritable risk for pancreatic cancer, or those with pancreatic cysts, through a novel model of collaboration and data sharing."

P=NA | N=NA | "ClearNote Health™...announced the publication of its analytical validation study for the Avantect™ Pancreatic Cancer Test in Clinical Gastroenterology and Hepatology. Data from the study...showed robust performance of the Avantect test in the detection of pancreatic cancer in high-risk patients, such as those recently diagnosed with Type 2 diabetes. These new data support the use of ClearNote Health’s epigenomic platform in effectively identifying cancer presence in individuals at higher risk for pancreatic cancer, thereby facilitating timely disease detection and intervention."

"ClearNote Health™ (formerly known as Bluestar Genomics)...announced that Chief Executive Officer Dave Mullarkey will present a company update at the 41st annual J.P. Morgan Healthcare Conference on Wednesday, January 11 at 2:30 p.m. PST. Mullarkey will discuss the company’s ongoing clinical validation and commercialization efforts across a multi-test portfolio. The Avantect™ early cancer detection portfolio includes the recently launched test for pancreatic cancer, available now for physician ordering in patients over 50 with Type 2 diabetes diagnosed in the past three years."