Micrograph of metastatic breast cancer to lymph node
Metastatic breast cancer to lymph node. Estrogen receptor positive. [OGphoto/Getty Images]

Epic Sciences, a diagnostics company applying a novel approach to classifying prostate and breast cancers to help guide therapy and detect disease recurrence announced it will partner with Fulgent Genetics for comprehensive genomic profiling of patients with metastatic breast cancer (MBC). The deal will leverage Fulgent’s CAP/CLIA next-generation sequencing capabilities with Epic’s new DefineMBC liquid biopsy test.

“Our deep collaboration with Fulgent has enabled Epic to bring this novel test to market and improve care for metastatic breast cancer patients much sooner,” said Jason Christiansen, CTO of Epic Sciences in a press release. “As we realized the interest in our early-access program, and high level of anticipation for the clinical launch, it became clear that Fulgent’s capability of delivering high-throughput testing with high quality and accuracy is essential for our launch.”

Epic announced the launch of DefineMBC in mid-December, a test that has been in development for the past couple of years using the company’s novel approach to liquid biopsies by both analyzing circulating tumor DNA (ctDNA) while also capturing live circulating tumor cells (CTCs). The combination of effectively providing both cell-based and cell-free analysis from a single blood draw has proven to be an effective diagnostic tool when there is no tissue available for analysis.

According to Epic, DefineMBC provides detection of CTCs, determination of intra-cell copy number variation of CTCs, assessment of HER2 and ER expression, plasma-based cell-free DNA analysis for identification of single nucleotide variants, indels, fusions, copy number variations (CNVs), as well as the calculation of microsatellite instability and tumor mutational burden.

Fulgent Genetics brings its expertise as a leader in the U.S. market in applying next-generation sequencing to the analysis of oncology samples and was one of the first companies I the country to offer copy number variation detection using NGS.

“We are pleased to collaborate with the Epic team on this important test for metastatic breast cancer,” said Brandon Perthuis, chief commercial officer of Fulgent Genetics. “Our highly scalable technology platform for Next Generation Sequencing makes Fulgent extremely well suited to power Epic’s clinical testing leveraging cfDNA, and for other high-volume blood-based offerings.”

Epic Sciences has been enrolling community cancer centers in an early access program for DefineMBC since its launch late last year, and has also offered the test to its existing research partners in the academic and pharmaceutical sectors.

According to Rick Wenstrup M.D., chief medical officer of Epic Sciences, the new test helps overcome the hurdles of limited tissue samples or in cases of advanced MBC where tissue biopsy is not routinely performed. “But patients’ cancers often evolve due to the impact of targeted therapies, ongoing clonal variations, and other known cancer dynamics,” he noted.

“DefineMBC delivers on the full potential of liquid biopsy, ensuring no information is left behind,” said Lloyd Sanders, CEO and president at Epic Sciences at the time of DefineMBC’s launch. “We are excited about the positive impact this product can have on patient care as well as the opportunity to provide critical data to drug development efforts.”

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