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J. Craig Venter, Ph.D.

Bluestar Genomics, the developer of an epigenomic platform focused on early cancer detection, has raised $70 million in an oversubscribed Series C equity financing—and named genomics pioneer J. Craig Venter, Ph.D., among two new members of its expanded scientific advisory board.

“Collectively, these milestones will extend our ability to deliver on our promise to improve on existing cancer screening and provide a new solution where none exists,” Samuel Levy, Ph.D., Bluestar’s CEO and Chief Scientific Officer, said in a statement.

Bluestar said the equity funding will enable it to advance its clinical development and commercialization efforts for its platform, which applies machine learning and the DNA-based 5-hydroxymethylcytosine (5hmC) biomarker as a screening method to detect cancer in multiple organs in men and women.

The company’s cell-free pancreatic cancer assay uses a standard blood draw to assess whether an individual has an abnormal epigenomic and genomic signature associated with the disease, by evaluating 5hmC changes in DNA that define biological activity in disease-relevant genes.

Based in San Francisco and San Diego, Bluestar was founded in 2016 to commercialize research by Stephen Quake, Ph.D., the Lee Otterson Professor of Bioengineering and Professor of Applied Physics at Stanford University and co-President of the Chan Zuckerberg Biohub.

Bluestar’s novel technology has shown positive results in two papers published in Nature Communications.

“Our data show that pancreatic cancer detection at early stages is possible with 5hmC-based methods,” a research team led by Quake and Levy concluded in one of those papers, detailing results from a 307-patient study published in October 2020. “Our data highlight the ability to detect differentially hydroxymethylated genes whose underlying biology shows association with both pancreas and cancer development as well as established trends in chromatin mark maps and other functional regions of the genome.”

In the second study, published in December 2020, a team led by Levy and Chuan He, Ph.D., of the University of Chicago described the development of a 5hmC tissue map by characterizing the genomic distributions of 5hmC in 19 human tissues derived from ten organ systems. The map, they reported, “suggests a potential role of 5hmC in tissue-specific development; as well as a resource to facilitate future studies of DNA demethylation in pathogenesis and the development of 5hmC as biomarkers.”

In March, Bluestar’s proprietary non-invasive pancreatic cancer detection test for patients with new-onset diabetes earned the FDA’s Breakthrough Device designation.

Venter, who co-led the Human Genome Project two decades ago and is now founder, Chairman, and CEO of the JCraig Venter Institute (JCVI), was named to Bluestar’s Scientific Advisory Board along with Felix Feng, M.D., a professor of radiation oncology, urology, and medicine at the University of California San Francisco (UCSF).

“As we continue to champion the development of next-generation non-invasive cancer detection, we welcome Drs. Feng and Venter to our team,” Levy added. “Their leading scientific and clinical expertise will help accelerate our development and commercialization efforts.”

Feng and Venter join Alan Ashworth, Ph.D., FRS, President of the Helen Diller Comprehensive Cancer Center, University of California, San Francisco.

“The convergence of innovative technologies has pushed the cost of multi-cancer screening down by 20-fold, allowing for continued optimization of cancer detection via routine blood draw to improve patient early treatment options,” Venter stated. “With the multi-cancer screening market projected to scale to more than $100 billion in the U.S. alone, Bluestar Genomics’ technology is uniquely positioned to address the needs of over 60 million patients. I am excited to become part of such a pivotal contribution to improving patient lives through completely unlocking the full potential of genomics.”

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