Bluestar Genomics has 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.
“ClearNote Health is focused on detecting cancer as early as possible, giving clinicians tools to identify cancer while it is still treatable. Our new brand reflects our aspiration to enable people to live longer, healthier lives with a clear understanding of their cancer biology, even if they are at risk for high-mortality cancers,” says Dave Mullarkey, chief executive officer of ClearNote Health. “Our focus remains on advancing cancer care – starting with pancreatic and ovarian cancers, where non-invasive early detection is very limited.”
LifeStrands Genomics will distribute the ClearNote Health pancreatic cancer detection test in Asia, starting with Singapore and Malaysia, where nearly 200,000 patients per year can benefit from knowing whether or not they have pancreatic cancer based on their recent Type 2 diabetes diagnosis, a leading risk factor for developing the disease. The test is already available in the U.S. through the ClearNote Health physician experience program. LifeStrands Genomics (LSG) is a Singaporean laboratory and a subsidiary of the Pathology Asia group, a diagnostic service provider in southeast Asia, headquartered in Singapore. The Pathology Asia group includes leading diagnostic labs in Singapore, Malaysia, Australia, and Indonesia, with a specialized genomics division.
“Southeast Asia, like many urbanized parts of the world, is seeing a dramatic rise in incidence of Type 2 diabetes, which is projected to increase 150% between 2000 and 2035. Since patients with Type 2 diabetes are at nearly eight times the risk of developing pancreatic cancer as the general population, the need for better diagnostic tools to detect pancreatic cancer is clear,” says Camille Cyncynatus, PhD, head of business development and partnership – genomics and life sciences at Pathology Asia group.
ClearNote Health has extensively validated its epigenomics-based detection approach to pancreatic cancer, which leverages the 5-hydroxymethylcytosine (5hmC) biomarker along with other genomic features to assess whether an individual has an abnormal DNA signal associated with pancreatic cancer, according tot eh company. The company shared results from its validation study at the American Pancreatic Association annual meeting last month. The tests are all performed in the company’s CAP-accredited, CLIA-certified laboratory in San Diego, Calif.