COMPANY:

ClearNote Health

"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."

"Bluestar Genomics announces today it received U.S. Food and Drug Administration (FDA) Breakthrough Device designation for its proprietary noninvasive pancreatic cancer detection test in patients with new-onset diabetes...Unlike current liquid biopsy cancer tests, this new test is performed with Bluestar Genomics’ groundbreaking epigenomics technology platform that employs state-of-the-art machine learning coupled with the DNA based 5-hydroxymethylcytosine (5hmC) biomarker as a screening method to detect cancer sooner."