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Boulder-based lung cancer diagnostic company Biodesix announced Tuesday that it has entered into an agreement with Thermo Fisher Scientific to bring a blood-based DNA sequencing analysis for liquid biopsies to the general public.

Unlike traditional biopsies, which require a surgery to obtain a piece of the tumor so that a pathologist can determine if the tumor is cancerous and, if so, what kind of cancer it is, liquid biopsies garner DNA that the tumor has shed into blood stream, eliminating the need for invasive surgeries and, by using DNA sequencing, speeding up the process for determining whether or not the tumor is cancerous.

“Time to treatment really matters, specifically for lung caner” David Brunel, the CEO of Biodesix, said. “So being able to draw blood when the patient initially shows up and have a result in two to three days can speed the time to which you’re getting on the correct therapy.”

After factoring in the necessary hospital visit, surgery, and pathology analysis involved in traditional biopsies, Medicare’s $3,000 estimate for the Biodesix and Thermo Fisher Scientific test will be less expensive.

Furthermore, because the test is minimally invasive, and therefore repeatable, it also allows doctors to monitor the response to various therapies in real time, allowing for novel approaches in the therapeutic management of cancer patients, according to a 2019 study conducted by the Department of Tumor Biology at the University Medical Center Hamburg-Eppendorf in Hamburg, Germany.

While the use of liquid biopsies is increasing rapidly, Brunel said less than half of cancer patients receive the test. By seeking FDA approval for their process of blood based sequencing, Biodesix and Thermo Fisher Scientific aims to democratize its use.

“By going through the FDA we get a national coverage decision from Medicare,” Brunel said. “We believe we have the necessary samples and data to convince them that this a high-quality test, that it’s reproducible, that we can perform it in our lab, and that patients and physicians can have confidence in the results.”

With the tests in place, Biodesix expects approval within a year.

Though the program will initially focus on patients with advanced non-small cell lung cancer, according to a news release, Biodesix and Thermo Fisher Scientific are currently working to expand the tests to include all forms of cancer. By targeting 52 genes across multiple cancer types, including lung, colorectal, breast, pancreatic, thyroid and others, the test has broad application for liquid biopsy clinical research applications, the release stated.

“If you have blood cancer, like lymphoma or leukemia, it’s very easy to sequence those,” Brunel said. “If you have lung cancer, breast cancer, pancreatic cancer, prostate cancer, ovarian, sometime it’s harder to get that circulating tumor DNA, but we’re trying to be able to get liquid biopsies for all of these types of tumors.”

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