Liquid biopsy tests are hitting the market soon thanks to biotech company Pathway Genomics Corporation.
The liquid biopsy tests are individual kits designed for consumers to detect whether there cancer-associated mutations are present in their blood. According to Pathway Genomics Corp., the tests are targeted both at healthy consumers, as well as at those who know they are at a high risk for cancer.
Certainly there are benefits to be gained once the liquid biopsy tests hit the market. Among them, the fact that they are non-invasive compared to the conventional tissue biopsies brings an added value both for consumers and patients.
Another positive aspect is that they are low-cost and not as time-consuming. However, while the idea of liquid biopsy tests is warmly welcomed by doctors, they also maintain that their release on the market is premature.
No clinical test results have been released, nor is there sufficient evidence to validate the sensitivity of the liquid biopsy tests. For healthy consumers, an unchecked result that indicates the presence of mutations could wreak havoc.
According to Doctor Keith Stewart, chief of the Mayo Clinic Center for Individualized Medicine and an oncologist:
“For any given test, the rate of false positives causing unnecessary alarm and false negative that provide false security should be known”.
The liquid biopsy test would be sold under the name CancerIntercept Detect. According to the CEO of Pathway Genomics Corp., Jim Plante, the test kit would come at a price of 699 dollars. If a consumer or patient chooses to be screen with CancerIntercept Detect quarterly, then the price decreased to 299 dollars.
Pathway is already known for pushing biotech directly to consumers. Backed by Founders Fund venture capital firm and Business Machines Corp., the startups is pushing its products while bypassing insurance coverage quite often.
While Pathway is not the only company that offers liquid biopsy tests, the technology is still in incipient phases and not backed by sufficient proof of its accuracy and sensitivity. Such tests screen the blood, detecting genetic material fragments coined as circulating tumor DNA.
A by-product of gene sequencing and technological advancements, the liquid biopsy tests hold great promise. Considering that through gene sequencing errant DNA can be spotted easily, even if there are only a few molecules in a sample, the potential of liquid biopsies for both doctors and patients is valuable.
However, with Pathway Genomics Corp. not releasing data on the studies it has conducted regarding the efficiency of liquid biopsy tests detecting circulating tumor DNA in both healthy and active patients, doctors remain skeptic.
According to Glenn Braunstein, the Chief Medical Officer with Pathway Genomics Inc., the studies exist and the results will be submitted to a panel for peer-reviewing.
The liquid biopsy test analyzed 96 genetic markers associated with cancers such as breast, lung, ovarian, melanoma and colon. CEO Plante stated that Pathway is not venturing far from the well-understood mutations for which a number specific treatments already exist.
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