Healthy individuals who are at risk of developing carcinomas could benefit from a newly-developed liquid biopsy that is capable of detecting blood mutations associated with cancer.
Researchers at Pathway Genomics Corp. have developed the new biopsy to serve as an affordable and non-invasive option to traditional and well-established tissue biopsies.
Despite the prospective benefits of liquid biopsies, doctors still stress the need for additional evidence in order to validate the sensitivity of the tests before the procedure could be offered to patients, particularly those who do not suffer from disease.
Jim Plante, the chief executive officer of Pathway Genomics, said that the company is offering liquid biopsy, known as CancerIntercept Detect, for $699. Consumers who will sign up to be tested by the company once every quarter will be allowed to avail of the treatment for only $299.
Plante said that the cost of the test provides people with a large advantage as undergoing a liquid biopsy could only be one-10th or one-20th of the price of an invasive biopsy.
The new liquid biopsy procedure involves screening the blood of patients for tiny genetic material fragments often released by tumors, which are called circulating tumor DNA. The test has only become available recently as sequencing of genes became even more affordable.
The technology used for the new biopsy has also improved significantly that researchers can now detect even the smallest amount of errant DNA molecules in a single vial of blood.
The first company to introduce monitoring for cancer patients through testing was Guardant Health Inc.
According to Plante, Pathway Genomics will also offer a separate liquid biopsy for active patients valued at $999 for each draw.
The San Diego-based Pathway Genomics joins a group of fellow health startups that offer affordable biopsies for healthy individuals, which often bypasses the coverage of insurance programs.
Some companies, including 23andMe Inc. and Color Genomics Inc., inform consumers about their vulnerability to certain illnesses through genetics, while others, such as Theranos Inc., encourage their consumers to pay close attention to general fitness by regularly monitoring key metrics such as cholesterol.
Some medical experts have expressed concern regarding the new liquid biopsies, stating that there are no available long-term studies on the ability of the procedures to identify early-stage cancer in healthy people.
Keith Stewart, head of the Center for Individualized Medicine of the Mayo Clinic, said that the liquid biopsy is not sensitive enough that it could result in false positives or false negatives diagnosis.
Stewart pointed out that he would like to see research that tracks high-risk individuals who undergo both traditional and liquid biopsies. He called the claim of Pathway Genomics to be premature.