Press Releases

Presentations at ESMO, AGBT Precision Health, and AACR Special Conference on Pancreatic Cancer demonstrate the value of the 5hmC biomarker in detection of breast, colorectal, lung, ovarian and pancreatic cancers

SAN DIEGO —September 12, 2022 –Bluestar Genomics, Inc., an early cancer detection company leading the development and commercialization of next-generation liquid biopsy tests initially focused on non-invasive detection of high-mortality cancers in high-risk patients, 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. They show the utility of epigenomics in cancer detection beyond the company’s growing body of evidence associated with its lead pancreatic cancer detection program. The latest scientific presentations underscore the clinical promise of the 5hmC biomarker in cancer detection and monitoring – including high-mortality and common cancers, such as breast, colon, lung, ovary, and pancreas.

“Pancreatic cancer is only one of many cancer types that can be detected using epigenomics and the 5hmC biomarker using our core platform technology,” said Samuel Levy, PhD, chief scientific officer of Bluestar Genomics. “Our current results demonstrate the accuracy of our blood-based cancer detection technology and the feasibility of widespread deployment of epigenomic technology, not only for early cancer detection, but also for understanding other biological changes, such as developing resistance to cancer treatments.”

The Bluestar Genomics approach to detecting cancer early is anchored in the process of tracking changes in cells in the body through unprecedented measurement of levels of the biomarker 5-hydroxymethylcytosine (5hmC) in a person’s blood. The 5hmC biomarker is stable, sensitive, and precise enough to detect not just the presence of cancer, but to also specify the location.

Advances in Genome Biology and Technology (AGBT) Precision Health, September 8-10, San Diego, Calif., U.S: 5hmC Technology Platform Shows Promise as Ovarian Cancer Detection Tool
At the AGBT Precision Health Conference, Bluestar Genomics presented a poster titled: Detection of Early-Stage Ovarian Cancer Using 5-Hydroxymethylation Profiles in Plasma-Derived Cell.” The results from a research study looking at isolating cell-free DNA and 5hmC from blood samples of ovarian cancer patients and non-cancer controls and leveraging whole genome sequencing in conjunction with proprietary bioinformatics and machine learning algorithms to identify samples from patients with ovarian cancer.

Ovarian cancer is the fifth-leading cause of cancer-related deaths among women and is often diagnosed in the advanced stage due to the lack of early detection tools.

The early development study results showed strong performance (83% sensitivity at 98% specificity) demonstrating the potential of the Bluestar Genomics 5hmC technology platform as an effective tool for ovarian cancer detection.

European Society for Medical Oncology (ESMO), September 9-13, Paris, France: 5hmC- based Epigenomic Analysis Reveals Strong Biological Association Between cell free DNA and Tumor Tissue
For the first time at this conference, Bluestar Genomics’ technology was highlighted in an oral presentation discussing research looking at tissue samples to understand how genes possess distinct 5hmC features that are different for cancer tissues and normal tissues. The large study included 1,009 cancer subjects and 1,678 non-cancer controls. The results showed that the differences in tissue-specific genes and 5hmC persisted across several cancer types studied (breast, colon, lung, ovary, and pancreas) and enabled highly accurate classification of cancer and normal tissues when compared with a machine learning model. Collectively, these features enable the identification of cancer from cell-free DNA across these cancer types. “5-hydroxymethycytosine Analysis Reveals Stable Epigenetic Changes in Tumor Tissue that Enable cfDNA Cancer Predictions” is available here.

American Association for Cancer Research (AACR) Special Conference on Pancreatic Cancer, September 13-16, Boston, MA, U.S.: Large Study Validates 5hmC-based Algorithm for Early Detection
At the American Association for Cancer Research: Special Conference on Pancreatic Cancer, a poster on the clinical validation efforts for the Bluestar Genomics pancreatic cancer classification model. The study validated an early-stage pancreatic cancer classification model using 5hmC profiles in plasma-derived cell-free DNA.

The researchers isolated cell-free DNA and analyzed 5hmC profiles from whole blood samples from 4,408 patients inclusive of both patients with pancreatic cancer and non-cancer controls. The validation of the pancreatic cancer detection algorithm on 2,150 patients showed a performance of 68 % sensitivity in stage I-II pancreatic cancer patients. All- stage performance results showed sensitivity of 67% and a specificity of 97%.

Pancreatic cancer outcomes are poor mostly due to the detection of cancer at late stages, underscoring the need for early detection.

The poster “Validation of an early-stage pancreatic cancer classification model using 5 Hydroxy-methylation profiles in plasma-derived cell-free DNA” can be found here.

About Bluestar Genomics
Bluestar Genomics is an early cancer detection company focused on the development and commercialization of non-invasive epigenomic tests to detect cancer through a standard blood draw, earlier than existing methods and when the disease is still treatable. The company uses its proprietary epigenomic platform that combines best-in-class AI-enabled bioinformatics and genomic technologies to analyze individuals’ changing biology that is yet to produce symptoms. Leveraging its novel liquid biopsy technology, Bluestar Genomics is initially focused on high-mortality cancers with the greatest need for early detection, starting with pancreatic and women’s cancers. With locations in San Diego and the San Francisco Bay Area, Bluestar Genomics collaborates with top research institutions and is supported by multiple global healthcare and technology investors and pharmaceutical collaborations.

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Victoria Steiner
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Investor Contact:
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