A new year brings a new name to San Diego-based Bluestar Genomics, which has commercialized its first test in the U.S. and internationally for early detection of pancreatic cancer in high-risk patients.
Late last year, Bluestar, which rebranded as ClearNote Health at the end of December, 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,” said Dave Mullarkey, chief executive officer of ClearNote Health. “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.”
“Our focus remains on advancing cancer care – starting with pancreatic and ovarian cancers, where non-invasive early detection is very limited,” Mullarkey added.
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 is a Singaporean laboratory and a subsidiary of the Pathology Asia group, the largest diagnostic service provider in southeast Asia, headquartered in Singapore. The Pathology Asia group includes leading diagnostic labs in 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,” said 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.
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.
ClearNote Health is a cancer detection company focused on enabling people at risk for high-mortality cancers to live longer healthier lives.
Utilizing a standard blood draw, the company applies its proprietary epigenomic platform, combining biology and artificial intelligence, to identify DNA-based changes in biology as cancer develops.
With lead programs in non-invasive early detection of pancreatic and ovarian cancers in patients at the highest risk for these diseases, ClearNote Health identifies cancers before they progress and when patients are most likely to benefit from treatment.
ClearNote Health is headquartered in Torrey Pines, with additional offices in the San Francisco Bay Area and internationally. The company’s CLIA- and CAP-accredited laboratory is located in San Diego.
FOUNDED: 2016 (as Bluestar Genomics)
CEO: Dave Mullarkey
HEADQUARTERS: Torrey Pines
BUSINESS: Diagnostic testing/cancer detection
NOTABLE: ClearNote Health’s proprietary epigenomic platform and cell-free DNA-based assays measure dynamic biological changes in cells to provide an early signal of developing cancer.