Our portfolio company Genalyte just announced the award of a government grant from the National Cancer Institute for the development of a diagnostic system using Genalyte’s proprietary biomarker technology (see Genalyte Expands into Cancer Profiling with $1 Million NCI Grant to Develop Cancer Biomarker Panel). This project is a significant validation of the company’s capability to assay blood biomarkers using the multiplex Maverick detection platform, which provides rapid, accurate, and scalable detection of proteins and nucleic acids in blood or other tissues. A single drop of blood or serum is all that is needed to run a multiplex analyte test on the Maverick platform.
Genalyte will collaborate with academic cancer researchers to select and validate the biomarkers to be included in the panel. Researchers at three academic sites led an NCI pilot project to prioritize cancer-related antigens as targets for immunotherapy, resulting in a list of 75 antigens that will be assessed in the new effort. Out of many available platforms, the NCI selected Genalyte as the best system available to evaluate the biomarkers for use in a Cancer screening and diagnostic panel.
The technology developed at Genalyte holds great potential as a diagnostic tool to monitor immune responses to cancer cells, the scientific basis for the approach. In the body, cancer cells are recognized as foreign invaders by the immune system, which mounts a response in an effort to prevent their growth. This early warning system, which is being used by drug developers to develop “immunomodulator” drugs, permits discrimination between cancer types and allows monitoring disease progression and the effect of therapy. The ability to easily characterize cancer antigens in patients will rapidly accelerate progress in cancer research and therapy development.
As an example of the potential value of a blood assay for cancer, consider lung cancer. Lung cancer is one of the most vicious killers in the field. Generally diagnosed symptomatically at a very late stage, five year survival rates of about 15% are typical. But, if lung cancer is diagnosed early, survival rates as high as 80% can be seen. So, a few years ago, NCI funded a large clinical trial to assess the value of using CT scans (computed X-rays) for early detection in at risk patients. The study found only a very small improvement in diagnostic value, at great expense and with a high false positive rate. The false positive rate from the test was as high as 50%, which led to expensive invasive biopsies with no cancer detected. Research in the last few years has shown that autoantibodies to lung cancer can be detected in the blood up to five years before a tumor is visible. This suggests the possibility that a blood diagnostic test might be viable, and this is what the NCI has awarded Genalyte the $1 million grant to discover. A high sensitivity and specificity blood bioassay with a low cost per test, very high predictive results, and ease of use in the clinic will lead to early detection and reduced lung cancer death rates. The NCI recognized that the missing link is a low cost, rapid, accurate detection system, and this is what Genalyte has to offer.
Founded in 2007, Genalyte, Inc., is commercializing the Maverick Detection System based on the company’s revolutionary Microring Sensor Technology, a new approach to multiplexing that uses a silicon chip containing arrays of photonic ring sensors to reduce or eliminate sample preparation and provide scalable multiplexing for both proteins and nucleic acids. The one-step workflow of the Maverick System can deliver accurate results in as little as 15 minutes from small volume samples of many types. It has a large dynamic range and excellent sensitivity with outstanding reproducibility.
For more information, visit www.genalyte.com.
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Claremont Creek Ventures specializes in investments in small companies with revolutionary health care innovations.
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