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FDA Grants Breakthrough Device Designation to Foundation Medicine Liquid Biopsy Assay

NEW YORK (GenomeWeb) – Foundation Medicine said today that the US Food and Drug Administration has granted Breakthrough Device designation to a new liquid biopsy assay the firm is developing, an expanded version of its existing FoundationACT assay.

Under the Breakthrough Device program, an expansion of the Expedited Access Pathways program, the FDA works with a test developer to reduce the time and cost from development to approval.

The new liquid biopsy assay will be a next-generation sequencing-based in vitro diagnostic device to detect substitutions, indels, copy number alterations, and select gene rearrangements in more than 70 genes, as well as to detect genome signatures that include microsatellite instability (MSI) and blood tumor mutational burden (bTMB), in circulating cell-free DNA isolated from plasma.

Foundation Medicine said it plans to seek FDA approval for the assay as a companion diagnostic to identify patients who may benefit from certain targeted therapies in accordance with approved labeling and to provide tumor mutation profiling for use in cancer patients according to professional guidelines.

If granted approval, the assay could be the first FDA-approved liquid biopsy test to incorporate multiple companion diagnostics and biomarkers to inform the use of targeted therapies, including immunotherapies, according to the company. However, others are working on similar approvals: Guardant Health, for example, said in February that the FDA granted its Guardant360 liquid biopsy assay Expedited Access Pathway designation.

Last November, the FDA approved Foundation Medicine's FoundationOne CDx tissue-based assay for solid tumors as part of a parallel review process that also led to a national coverage determination for the test and others like it by the Centers for Medicare and Medicaid Services.

"We're pleased to continue our work with the FDA applying this expertise to our liquid biopsy franchise with the potential to offer oncologists multiple FDA-approved options that enable biomarker-driven care and ultimately better outcomes for patients," said Vincent Miller, Foundation Medicine's chief medical officer, in a statement. "The acceptance of this assay for Breakthrough Device designation is an important step in advancing precision medicine options for patients, including the potential intended use as a companion diagnostic across multiple types of cancer, which will also help our biopharma partners accelerate their development efforts for these programs."

One criterion Foundation Medicine said it had to meet to have the liquid biopsy assay included in the program is a "large unmet medical need for comprehensive genomic profiling of tumors for cancer patients for whom a tissue sample is unavailable for testing."

Cowen analyst Doug Schenkel said in a note to investors this morning that the inclusion of Foundation Medicine's liquid biopsy assay in the Breakthrough Devices program might help the firm catch up with competitors. "While we remain very enthused about FMI’s position in solid tumors and are enthused about this development with the FDA, our belief is that FMI currently lags Guardant in liquid biopsy product and commercial development efforts," he and his colleagues wrote. "This development could help close the gap."

In Thursday morning trade on the Nasdaq, shares of Foundation Medicine were up nearly 5 percent at $77.50.