The company announced last week that Viome Life Sciences, a biotech company founded in 2016, has launched CancerDetect, a diagnostic test for mouth and throat cancer that uses mRNA technology and an artificial intelligence platform.
The test is a direct-to-consumer product priced at $399. If people wanted to take the test, they would order from Viome’s website. Customers must fill out a questionnaire assessing age, health habits, smoking and other aspects. Health care providers at PWNHealth in New York City, working with Viome, review questionnaire requests within 48 hours.
If the consumer is eligible, the test will be shipped to their home. The company’s chief technology officer, Dr. Guru Banavar, says they take a saliva sample first thing in the morning and send it to Viome’s lab.
“Saliva samples are easy to collect,” he said. “It’s ideal first thing in the morning after a good night’s sleep, fasting for eight hours without brushing, for best results.”
in Bellevue, Washington Wiom The product is then tested using a technique called metatranscriptomics, which can identify RNA and be able to detect cancer as early as the first stage. clinical research The completed test determined that CancerDetect has a specificity of 95%, which means few false positives, and a sensitivity of 90%, which means few false negatives.
PWNHealth providers review the tests, then contact consumers via email and provide a PDF report of the results within four weeks of sending the saliva sample. If cancer is detected, doctors conduct a telehealth consultation over the phone to review the results, answer any questions and guide the patient through the next steps, Banavar said.
Banavar touts that CancerDetect is different from other cancer tests because it requires a saliva sample for RNA rather than a blood sample for DNA, making it less invasive. A person’s RNA is always changing and more reflective of people’s living habits, making the results more accurate, he said. DNA is stagnant and doesn’t change based on people’s choices.Other cancer tests include those from biotech companies Holy Grail and molecular diagnostics exact sciencewhich takes blood samples instead of saliva samples and requires consumers to enter a health care facility.
CancerDetect received FDA Breakthrough Device Designation in May 2021 because of its advancements and tests for RNA rather than DNA, Banavar said.
While Viome is able to market the test, the company is conducting a pivotal study to gain FDA marketing authorization, which would allow the test to be insured. Banavar is expected to gain market authorization in about a year, he said.
Viome plans to create more diagnostic tests for a range of chronic diseases and cancers beyond mouth and throat cancer. Currently, the company is considering developing a test for colorectal and other gastrointestinal cancers, Banavar said.
“We hope to develop many diagnostics like CancerDetect in the future,” he declared.
Credit: Apple Design, Getty Images
