Viome Life Sciences, a biotechnology company founded in 2016, has launched CancerDetect, a diagnostic test for oral and throat cancer that uses mRNA technology and an AI-powered platform, the company announced last week.
The test is a direct-to-consumer product and costs $399. If people want to take the test, they order it from Viome’s website. Customers have to complete a questionnaire that assesses age, health habits, smoking and other areas. A healthcare provider — from New York City-based PWNHealth, which partners with Viome — reviews the questionnaire request within 48 hours.
If consumers are eligible, the test is shipped to their house. They then take a saliva sample first thing in the morning and send it to Viome’s lab, said Dr. Guru Banavar, the company’s chief technology officer.
“The saliva sample is very easy to collect,” he said. “It fits first thing in the morning after a good night’s sleep and fasting for eight hours without brushing your teeth to get the best possible result.”
Bellevue, Washington-based Viome then tests the product using a technology called metatranscriptomics, which identifies RNA and is able to detect cancer as early as Stage 1. A clinical study done on the test determined that CancerDetect has 95% specificity, meaning there are few false-positives, and 90% sensitivity, meaning there are few false negatives.
Within four weeks, a PWNHealth provider reviews the test and then contacts the consumer by email with a PDF report of the results. If cancer is detected, the physician then conducts a telemedicine consultation via phone to go over the results, answer any questions and walk patients through the next steps, Banavar said.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
CancerDetect differs from other cancer tests because it takes a saliva sample that tests for RNA instead of a blood sample that tests for DNA, making it less invasive, Banavar touted. A person’s RNA is always changing and is more reflective of people’s lifestyle habits, making results more accurate, he said. DNA is stagnant and does not change depending on people’s choices. Other cancer tests include one from biotechnology company Grail and another from molecular diagnostics company Exact Sciences. Both take a blood sample instead of a saliva sample and require consumers to go into a healthcare facility.
CancerDetect received FDA Breakthrough Device Designation in May 2021 because of its advances and testing for RNA instead of DNA, Banavar said.
While Viome is able to to market the test, the company is doing a pivotal study to receive FDA market authorization, which will allow the test to receive insurance coverage. Banavar expects to receive market authorization in about a year, he said.
Viome is planning to create more diagnostic tests for a range of chronic diseases and cancers beyond oral and throat cancer. Currently, the company is thinking about developing a test for colorectal cancer and other gastrointestinal cancers, Banavar said.
“We expect to develop many diagnostics like CancerDetect in the future,” he declared.
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