COMPANY:

ClearNote Health

"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."

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."

"Bluestar Genomics...announced the company’s U.S. and international commercialization of its first test for early detection of pancreatic cancer in high-risk patients, and unveiled a new name, ClearNote Health™. The company also announced its first international distribution agreement with LifeStrands Genomics, a part of Pathology Asia’s Genomics and Life Sciences division...LifeStrands Genomics will distribute the ClearNote Health pancreatic cancer detection test in Asia, starting with Singapore and Malaysia"

"Bluestar Genomics, Inc...announced the initiation of the New Onset Diabetes Management for Earlier Detection (NODMED) trial, one of the largest clinical studies in pancreatic cancer to date. The trial will use Bluestar Genomics’ proprietary epigenomic methods for detection of the disease...This large, prospective multi-site study is designed to clinically validate the Bluestar Genomics test to detect whether an individual has an abnormal DNA signal associated with pancreatic cancer."

"Bluestar Genomics, Inc...announced the results of a validation study for its early pancreatic cancer detection test...The results from the recently completed case-control validation study show the Bluestar Genomics test performing at 67% sensitivity and 97% specificity in a population of 2,150 patients over age 50. Its study cohort included patients recently diagnosed with Type 2 diabetes, a population with eight times the risk of developing pancreatic cancer."

"Bluestar Genomics, Inc...announced it received accreditation for its clinical laboratory from the College of American Pathologists (CAP). The certification enables the company to serve physicians and patients globally as it works towards broad commercialization of its first test for the detection of pancreatic cancer."

"Bluestar Genomics, Inc...announced the results from multiple studies highlighting the expansion of the company’s technology platform into ovarian cancer detection and tumor tissue analysis...These new data highlight promising research on the 5hmC biomarker-based approach to noninvasive detection of a broad range of cancers including those with poor survival like pancreatic and ovarian."

"Bluestar Genomics, Inc...announced it has received Clinical Laboratory Improvement Amendments (CLIA) certification from the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services...As part of the certification process, Bluestar Genomics recently completed analytical validation evaluating the accuracy and reliability of the company’s early detection test for pancreatic cancer."

"Bluestar Genomics, Inc...today announced positive performance evaluation study results for its pancreatic cancer test. These data confirm that its pancreatic cancer test detects the disease with 55.2% sensitivity and 98.4% specificity in patients with and without diabetes. The study results will be presented on January 21 at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium in San Francisco."

"Bluestar Genomics...announced the presentation of new analytical performance data on its proprietary non-invasive pancreatic cancer test at the American Pancreatic Association (APA) annual meeting. Data from the study showed that the company’s test detected a pancreatic cancer signal in people across various age groups, including patients with new-onset diabetes, occurring in 25% of new pancreatic cancer cases."