Large Clinical Study Supports Prognostic Utility of Saliva-Based TeloTest™
MENLO PARK, California, Nov. 28, 2012 /PRNewswire – Telome Health, Inc. (THI), developer of the TeloTest™ diagnostic test that measures average telomere length, announces the planned launch of the saliva-based TeloTest in the first quarter of 2013. Related telomere tests, including percentage of short telomeres, would follow.
Telome Health’s TeloTest™ will be the first saliva-based telomere test available on the market. THI leverages the predictive power of data related to telomeres, the protective caps at the ends of chromosomes, to help assess health status, disease and mortality risk, and response to specific therapies.
The utility of testing telomere length in a saliva-based test was recently reported from an independent, large clinical study sponsored jointly by Kaiser Permanente, University of California, San Francisco (UCSF), and National Institutes of Health, in which the average telomere length of 100,000 Kaiser patients was measured and analyzed relative to other health domains and clinical outcomes. (http://www.nlm.nih.gov/
In the Kaiser-UCSF study, subjects’ medical records were analyzed to confirm health status over a 2-year period prior to telomere testing. This study provides an analytical foundation for the prognostic power of the TeloTest. The study showed that individuals who had short telomeres had increased risk of death in the three-year follow up period, and that smoking, heavy alcohol consumption, lower education, and poor environments were associated with short telomeres, while moderate exercise was associated with longer telomeres. The mortality risk data remained statistically significant even after accounting for lifestyle factors. These and other observations are consistent with earlier studies on blood cell telomere length.
“We knew that telomere length from cells in saliva correlated relatively well with that in blood cells, but it was important to see that key clinical associations were also preserved,” stated THI’s chief scientific officer, Calvin Harley, Ph.D.
The UCSF team that conducted telomere measurements was led by Dr. Elizabeth Blackburn, 2009 Nobel Laureate in Physiology and Medicine. The technology used was qPCR, an extremely well-established technology used in a very broad range of molecular diagnostic testing, including telomere length. THI licensed the exclusive, world-wide rights to qPCR-based telomere testing from the University of Utah in 2010.
“The strong clinical data and availability of the saliva-based TeloTest will be the foundation upon which Telome Health’s Wellness business will be built. Because saliva samples can be conveniently collected in a doctor’s office or at home with a non-invasive kit, the saliva-based test provides an important strategic differentiator from other telomere tests that are currently available, and is a better test overall due to our qPCR assay technology, which is scalable, cost-effective and we believe will be the dominant technology for high-throughput assays,” explains Lennart Olsson, M.D., CEO of Telome Health. “We are actively gearing up for a controlled launch early in 2013 from our clinical laboratory.”
“Telomeres are one of the few parts of the genome that can be changed by lifestyle choices, and hence telomere length measurements can provide valuable feedback on ones’ disease risks and, potentially, the effects of lifestyle changes,” stated Elizabeth Blackburn, Telome Health’s Co-founder and Chair of the Scientific and Clinical Advisory Board. “The data from the saliva-based testing in the large Kaiser-UCSF research study is an exciting step forward in the field of telomere science, as it helps to advance the use of telomere testing into regular clinical practice.”
Telome Health’s proprietary saliva-based TeloTest™ will provide doctors with important data about their patients’ health and disease risk to better inform their clinical decisions. In addition to clinical utility, measuring telomere length will also allow people to gauge their overall health status and determine whether lifestyle changes are necessary, and potentially indicate the effectiveness of those changes.
Over 10,000 peer-reviewed scientific publications relate to telomere biology and aging or disease and many support the diagnostic utility of telome measures to monitor health status, disease risk, prognosis, and drug response. Some of these studies establish both associations and causal links between short telomeres or altered telomerase levels and major diseases including cancer, cardiovascular, fibrotic, inflammatory and infectious diseases, depression, and diabetes. While most biomarkers are specific for certain diseases, telomere shortness uniquely is a parameter predictive of an increased risk of many co-morbid diseases and in some studies, it is superior to conventional biomarkers. Recent data have also suggested that telomere length may help predict responders, non-responders, or subjects who are at increased risk for negative side effects of certain drugs.
The multiple applications of telomere-based diagnostics measurement toward prevention, wellness, and individualized treatment can support a paradigm shift for healthcare.
About Telome Health, Inc.
Two of THI’s founders played key roles in developing the field of telomere biology: Professor Elizabeth Blackburn, Ph.D. (UCSF), the 2009 Nobel Laureate in Physiology or Medicine for her seminal work on telomere structure and function and the discovery of telomerase, the enzyme that synthesizes telomeric DNA; and Calvin Harley, Ph.D., who linked telomeres and telomerase to human cell aging and disease, and translated telomere science into drug development at Geron Corporation as VP Research and Chief Scientific Officer.
There are over 180 million people in the US over age 30 – and a growing number of them have an interest in actively managing their health. THI founders believe that telomere length as an overall health barometer will be an integral component in the personalized medicine revolution, which includes individualized health maintenance plans based on new health monitoring tools. As the field of telomere biology continues to evolve, THI will develop and commercialize additional diagnostics based on telomere biology. The company currently provides telomere length testing for academic, pharmaceutical, and corporate research groups.
This news release may contain forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release regarding potential applications of THI’s technology constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and protection of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements.
For more information, contact: Jeanette Smith, +1-650-289-0289