The assay, being developed in partnership with Johnson & Johnson, will complement computed tomography imaging by combining 26 genes and clinical variables for lung cancer detection.
While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
The company announced this week the expansion of a genetic testing program for US patients with inherited retinal disease that it has run with partners since 2017.
According to Natera CEO Steve Chapman, the agreement will not detract from Natera's own efforts to establish its exome sequencing-based Signatera assay.
The company said it has seen progress in efforts to get FDA approval for its tissue and liquid biopsy tests as data continues to accumulate for pan-cancer utility.
