Telome Health (Menlo Park, Calif.) plans to launch a saliva-based test of telomere length, protective caps at the ends of chromosomes, to help assess health status, disease and mortality risk, and response to specific therapies. Data presented at the American Society of Human Genetics (ASHG) annual meeting (San Francisco; Nov. 6-10) demonstrates the prognostic utility of the test.“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 one’s disease risks and, potentially, the effects of lifestyle changes,” said Telome Health co-founder Elizabeth Blackburn, Ph.D., who received the Nobel Prize for her telomere discoveries. “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 acquired the worldwide rights to the quantitative polymerase chain reaction-based telomere test from the University of Utah in 2010. This new study also confirmed that clinical associations with telomere length remain preserved when using saliva specimens rather than blood. The TeloTest diagnostic test measures the average telomere length, which is known to shorten with age. But the rate of shortening can be accelerated because of stressors—a variety of biochemical, viral, or mechanical stressors. The company believes using telomere length as a “health barometer” can be useful in personalizing clinical care and health maintenance. The Kaiser Permanente-University of California San Francisco study linked subjects’ medical records with telomere testing results in 100,000 participants. The study showed that individuals who had the shortest telomeres had a significantly increased risk of death over the three-year follow-up period, even after adjusting for lifestyle factors. Smoking, heavy alcohol consumption, lower education, and poor environments were associated with short telomeres, while moderate exercise was associated with longer telomeres. “If you understand your baseline telomere length you can change your lifestyle or drug regime and use telomere length to monitor it,” Calvin Harley, Ph.D., Telomere Health’s chief scientific officer, tells DTTR. “We also know that rate of loss of telomere length is important and we can monitor over time.” Harley explains that the company plans a three-stage commercial rollout. In the first stage, the test will be offered as a measurement for wellness, with a soft launch expected first quarter. The lab-developed test will be run in the company’s soon to be licensed Clinical Laboratory Improvement Amendments-waived laboratory with a hard launch to follow in the second quarter. Physician orders are required and the test will initially require out-of-pocket payment, anticipated primarily through concierge physicians and corporate wellness groups. In the second phase, expected in 2014, the test will incorporate telomere length as a clinical diagnostic factor including a clinical diagnostic threshold for which doctors can take “more aggressive drug intervention,” Harley says. The third phase, which will be two years to five years away, would be to get TeloTest approved through the U.S. Food and Drug Administration as a companion diagnostic to monitor therapeutic effect.