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Liquid Biopsy for Solid Tumors Now Available

Blood sample tubes

(CDC.gov)

24 September 2018. A test that inspects a patient’s blood sample for characteristic indicators of solid-tumor cancer, and can be part of a comprehensive precision analytics program, is now on the market. FoundationOne Liquid is a product of Foundation Medicine in Cambridge, Massachusetts, a subsidiary of the Roche Group, a pharmaceutical and diagnostics company in Basel, Switzerland.

FountationOne Liquid analyzes blood samples from patients suspected of having a solid-tumor cancer, such as breast, colon, or lung cancer. The blood test, says Foundation Medicine, uses a form of high-throughput genomic sequencing to look for circulating tumor cells that break away from the primary tumor and can be detected in the blood stream. The test targets 70 genes associated with cancer using algorithms looking for 4 types of genomic alterations: base substitutions, insertions and deletions, copy number alterations, and rearrangements.

FoundationOne Liquid also detects high levels of microsatellite instability, a condition where the number of short, repeated DNA sequences differ from the number of repeats in inherited DNA, which makes repairing errant copied DNA difficult. Blood samples are analyzed in Foundation Medicine labs, says the company, with results returned in less than 2 weeks.

The company says FoundationOne Liquid can also be used as part of FoundationOne CDx, a more comprehensive genomic profile for cancer patients that provides evidence for precision medicine treatments. FoundationOne CDx performs high-throughput genomic sequencing of DNA samples from cancer patients reporting on 324 genes most associated with tumor growth to help determine the most promising available treatments. As reported by Science & Enterprise, FDA approved FoundationOne CDx in December 2017 for patients with certain types of non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer, or breast cancer where the results are matched to 15 treatment options approved for those conditions, including 12 first-line therapies.

FoundationOne CDx also reports on microsatellite instability, as well as tumor mutational burden, a quantitative measure of the total number of mutations per coding error in a tumor genome. Tumors with a higher level of mutational burden are considered more likely to express immune-system targets specific to those tumors, making them better candidates for immunotherapies. Unlike Foundation One Liquid, however, FoundationOne Dx requires tissue samples from patients.

“Cancer is a disease of the genome and genomic profiling of every patient’s tumor at the start of their treatment journey will provide transformative outcomes for patients,” says Sandra Horning, Roche’s chief medical officer, in a Roche Group statement. The company believes FoundationOne Liquid will meet a particular need for people without sufficient or adequate tissue for a traditional biopsy. About 15 percent of patients with non-small cell lung cancer, for example, do not have tissue for biopsies, while 10 percent of individuals with this disorder produce biopsies too small to assess.

Foundation Medicine began in 2010, founded by researchers from Harvard Medical School, Dana-Farber Cancer Institute affiliated with Harvard, and MIT. In January 2015, Roche took a $1.2 billion equity stake in the company. In June 2018, Roche completed the acquisition of Foundation Medicine in a deal valued at $2.4 billion.

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