The technology behind Viome's at-home saliva test has received FDA breakthrough designation, powering the first test in the world to detect biomarkers associated with oral cancer and throat cancer with 95% specificity and 90% sensitivity rates
BELLEVUE, Wash., Aug. 4, 2022 /PRNewswire/ -- Viome Life Sciences, a mission-driven biotechnology company, announces the arrival of its CancerDetect™ test for oral & throat cancer, the first to launch in a series of diagnostic tests in development. This test is the first to detect biomarkers for early-stage oral and throat cancers based on technology that has received FDA Breakthrough Device Designation. CancerDetect™ is available to individuals at higher risk of developing these cancers, fulfilling an unmet need for advanced, earlier detection when it is most easy to treat. Viome's launch of the CancerDetect™ signifies a promising future for saliva-based, early cancer detection testing with Viome's advanced mRNA technology and AI-powered platform.
CancerDetect™ brings unprecedented accuracy to early cancer detection and prevention as the only oral and throat cancer test to offer detection with 95% specificity and 90% sensitivity. Oral and throat cancer is notoriously difficult to detect. Until now, it can often go undiagnosed until it has reached an advanced stage due to a lack of effective diagnostics tools, leading to low survival rates. Only 28% of patients receive an early diagnosis, and those receiving a late diagnosis face a prolonged battle with oral cancer. (National Library of Medicine). Early detection directly increases the 5-year survival rate for oral cancer patients, from 50% to 84%. With CancerDetect™, Viome has developed a much-needed aid to detect early-stage cancer, leading to more successful treatment outcomes when confirmed with a biopsy.
"Despite all the innovations across the health landscape, oral and throat cancer has remained life-threatening diseases with few options for early detection," said Naveen Jain, Founder and CEO of Viome Life Sciences. "As an industry leader on a mission to identify and address the roots of chronic disease, we have been working for years to bring to market clinically-backed diagnostics solutions for cancer detection and other life-threatening and debilitating diseases. With the launch of CancerDetect™ for Oral and Throat Cancer, we have achieved this goal and plan to follow this in rapid succession with detection tools for additional life-threatening chronic diseases and cancers."
CancerDetect™ marks the latest addition to Viome's suite of clinically-backed Intelligence™ wellness tests, including the recently-launched Full Body Intelligence™ Test, the most advanced at-home microbiome test available. Following the success of CancerDetect™ for oral and throat cancer, Viome is focused on enhancing its tests for the spectrum of GI disorders, including cancers.
About Viome Life Sciences
Viome Life Sciences is a mission-driven biotechnology company founded in 2016 to address the epidemic of chronic diseases, cancer, and aging. To help individuals improve their health and to understand the root of chronic diseases better, Viome is strategically split into two divisions. Viome Consumer Services is focused on growing its established consumer products, including wellness tests, nutrition plans, and supplements. Viome Health Sciences is devoted to advancing its precision diagnostics and therapeutics platform. By conducting mRNA analysis at a mass scale, Viome digitizes human biology and ultimately prevents the onset and progression of chronic diseases. For more information on CancerDetect™, please visit viome.com and viomelifesciences.com.
SOURCE Viome Life Sciences