Genomic Tests: Two New Assays Win FDA Breakthrough Device Designation
Earlier this month, the FDA finalized new rules designed to relax the regulatory obstacles faced by manufacturers in commercializing new genetic health risk assessment tests. And now an earlier liberalization program called the Breakthrough Devices program is starting to have an impact on diagnostics test makers. The Breakthrough Device Designation For decades, the FDA has been criticized for blocking patient access to new treatment technologies. Adopted as part of the 2016 21st Century Cures Act legislation addressing those concerns by, the Breakthrough Device program is an expansion of the Expedited Access Pathways program that enables test makers to work together with the FDA to cut development costs and approval lead time. In the past six weeks, a pair of test makers announced Breakthrough designations for new assays. According to the company, if the assay is ultimately approved, it would become the first FDA-approved liquid biopsy to incorporate multiple companion diagnostics and biomarkers to inform the use of targeted therapies, including immunotherapies. FoundationACT Assay On April 26, Foundation Medicine announced that the FDA had granted Breakthrough Device designation to the new liquid biopsy assay the company is developing as an expanded version of its FoundationACT assay. The NGS-based IVD for detecting […]
Earlier this month, the FDA finalized new rules designed to relax the regulatory obstacles faced by manufacturers in commercializing new genetic health risk assessment tests. And now an earlier liberalization program called the Breakthrough Devices program is starting to have an impact on diagnostics test makers.
The Breakthrough Device Designation
For decades, the FDA has been criticized for blocking patient access to new treatment technologies. Adopted as part of the 2016 21st Century Cures Act legislation addressing those concerns by, the Breakthrough Device program is an expansion of the Expedited Access Pathways program that enables test makers to work together with the FDA to cut development costs and approval lead time.
In the past six weeks, a pair of test makers announced Breakthrough designations for new assays.
According to the company, if the assay is ultimately approved, it would become the first FDA-approved liquid biopsy to incorporate multiple companion diagnostics and biomarkers to inform the use of targeted therapies, including immunotherapies. |
FoundationACT Assay
On April 26, Foundation Medicine announced that the FDA had granted Breakthrough Device designation to the new liquid biopsy assay the company is developing as an expanded version of its FoundationACT assay. The NGS-based IVD for detecting substitutions, indels, copy number alterations and gene rearrangements in 70 genes as well as genome signatures in circulating cell-free DNA isolated from plasma, is being created as a companion diagnostic to identify patients who may benefit from certain cancer therapies. According to the company, if the assay is ultimately approved, it would become the first FDA-approved liquid biopsy to incorporate multiple companion diagnostics and biomarkers to inform the use of targeted therapies, including immunotherapies. However, other firms, including Guardant Health, are developing similar products.
AutoGenomics Opioid Dependency Panel
On June 6, AutoGenomics said that it had gained Breakthrough Device designation for its Infiniti Neural Response Panel, a genomic test for assessing opioid dependency to be used by physicians in prescribing pain medications. "We believe that this multi-variant addiction panel with its predictive algorithm represents a significant tool for healthcare practitioners to identify and better manage patients at risk of opioid dependency," noted AutoGenomics President and CEO Fareed Kureshy in a statement.
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