COMPANY:

ClearNote Health

"ClearNote Health...today announced that it has received UK Conformity Assessed (UKCA) marking for its Avantect® Pancreatic Cancer Test. The UKCA mark, established as part of the United Kingdom’s independent product safety regulatory framework following its departure from the European Union, signifies compliance with UK medical device regulations and paves the way for commercial availability in the UK market."

"ClearNote Health...announced initiation of patient enrollment for a landmark clinical study utilizing its Avantect Pancreatic Cancer Test. Sponsored by University Hospital Southampton NHS Foundation Trust, the prospective, multicenter study seeks to improve early detection of pancreatic cancer in individuals recently diagnosed with type 2 diabetes. With up to 15,000 patient participants, it will be the largest study of its kind."

"ClearNote Health...today announced a lineup of presentations at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago taking place April 25-30, 2025. Meeting attendees can learn about ClearNote Health’s innovative early cancer detection technology and latest clinical research success."

"ClearNote Health...today announced an agreement with Claritev, Inc. (“Claritev”) (NYSE: CTEV), previously MultiPlan, Inc. As part of the agreement, ClearNote Health’s Avantect® Pancreatic Cancer Test will now be available to health plan members accessing Claritev’s national PHCS and MultiPlan Networks."

"ClearNote Health...announced that the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) has approved its Avantect Pancreatic Cancer Test. With this approval, clinicians in New York State can now order this highly sensitive blood test, which is designed to detect the biological signals of pancreatic cancer in its earliest stages for patients with known risk factors....The Avantect Pancreatic Cancer Test is for patients at high risk of pancreatic cancer, including those newly diagnosed with type 2 diabetes who are at least 50 years old, as well as those with a family history and/or a genetic predisposition."

"ClearNote Health...announced that its Avantect® Multi-Cancer Detection Test was selected for the Vanguard Study funded by the National Cancer Institute (NCI), part of the National Institutes of Health. The Avantect Multi-Cancer Detection Test was one of two tests selected after a thorough evaluation of emerging multi-cancer detection technologies. The Vanguard Study aims to address the feasibility of using targeted multi-cancer detection tests in randomized controlled trials (RCTs) designed to assess the clinical benefit of cancer detection, possibly in the early stages, through noninvasive blood tests."

"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 results from a collaboration study with Novartis and the Norwegian Biobank assessing plasma-based epigenetic biomarkers associated with response to treatment with Lutathera® ([177Lu]Lu-DOTA-TATE) in patients with pancreatic neuroendocrine tumors."

"Personalis, Inc...unveiled an alliance through which Personalis will expand its pharmaceutical service offerings by distributing ClearNote’s cutting-edge epigenomic 5-hydroxymethylcytosine (5hmC) platform...The partnership marks a pivotal moment in cancer research, leveraging the strengths of both companies to offer unparalleled solutions in the biopharmaceutical industry."

"New data published in The Journal for ImmunoTherapy of Cancer show ClearNote Health’s epigenomic platform may provide a novel tissue-free, liquid biopsy-based approach for prediction and monitoring of immunotherapy response for non-small cell lung cancer patients....In the study, ClearNote Health’s epigenomic platform was used to generate cell free DNA (cfDNA) 5-hydroxymethylation (5hmC) profiles from 151 plasma samples obtained from 31 patients with NSCLC who received programmed death-1 (PD-1) receptor inhibitors, pembrolizumab or nivolumab, as monotherapy. The comparison of plasma-derived cfDNA 5-hmC profiles revealed differences that distinguish patients responding to therapy from those not responding before and throughout treatment."

"ClearNote...today announced it has entered into a collaboration with Bayer to evaluate biological mechanisms underlying patient response and resistance to treatments for metastatic hormone-sensitive prostate cancer. The companies will apply ClearNote Health’s epigenomic cancer detection platform to liquid biopsy samples to monitor patient response to prostate cancer therapies. The collaboration aims to provide a deeper understanding of disease biology to help advance Bayer’s precision medicine programs in prostate cancer."

"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."