On January 29, 2020 Bluestar Genomics, a company developing innovative, data-driven, epigenomic approaches to comprehensive disease analysis and diagnostics, reported the publication of a new study demonstrating the efficacy of their 5-hydroxymethylcytosine (5hmC) signal detection technology for its use in breast, lung, pancreatic, and prostate cancer (Press release, Bluestar Genomics, JAN 29, 2020, View Source [SID1234553663]). The study was published online in medRxiv. Results from the study provide further evidence that, using a single blood draw, Bluestar Genomics’ technology can non-invasively detect cancers and help identify the underlying biology of the disease using epigenetic markers.
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Breast, lung, pancreatic, and prostate cancer make up 41% of the cancer incidence in the United States. Early detection and a deep understanding of each cancer remain critical for implementing the highest quality of care. Tissue biopsy is invasive, and screening methods are limited for many forms of cancer and often fall short of capturing the complete genomic landscape. Bluestar Genomics uses liquid biopsy combined with 5hmC profiling to provide a detailed picture of the genomic landscape and identify potential biologic pathways that may be driving tumor progression.
"We have taken significant strides to strengthen our understanding of the underlying biology related to multiple forms of cancer and the tumor microenvironment," said Samuel Levy, Chief Executive Officer and Chief Scientific Officer, Bluestar Genomics. "In addition to early-stage cancer detection capabilities, our knowledge of 5hmC distribution across the genome can potentially yield new candidate biomarkers. With this information, we will create clinical tools that can revolutionize oncology screening and have a significant impact on patient outcomes."
Bluestar Genomics executed the study using multiple cell-free DNA samples to measure 5hmC profiles from patients with breast, lung, pancreatic, and prostate cancer. When used in conjunction with machine learning-based classification methods, their novel enrichment technology exhibited high performance in classifying these samples with Area Under the Curve (AUC) measures of 0.89, 0.84, 0.95 and 0.83, respectively. The majority of the breast and pancreatic cancer samples were stage 1 or stage 2, validating Bluestar Genomics’ potential to aid clinical decision making and detect cancer when treatment is most effective.
"There are significant limitations in screening for various cancers," said Kelly Bethel, MD, Chief Medical Officer, Bluestar Genomics. "Our research data outperforms screening PSA testing, the current standard of care screening blood test for prostate cancer. Detection of small early malignancies is challenging by usual imaging methods, and our platform technology also demonstrates the ability to detect the presence of malignant tumors smaller than 2cm. Overall, these findings suggest a clinical path toward early detection as part of a multi-cancer screening test."
These results were presented by Anna Bergamaschi, Ph.D., Principal Scientist, Bluestar Genomics at the PMWC 2020 Silicon Valley conference on January 23 at the Liquid Biopsy Showcase.