Pillar Biosciences has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its OncoReveal CDx pan-cancer next-generation sequencing (NGS) test for general solid tumor profiling.
The FDA’s premarket approval decision expands the 2021 indication of OncoReveal Dx for EGFR and KRAS-targeted therapy for patients with non-small cell lung cancer (NSCLC) and colorectal cancer.
Pillar Biosciences said the companion diagnostic vitro diagnostic (IVD) test could be used for solid tumor profiling in any NGS lab running an Illumina MiSeq Dx System, whether in a hospital or a commercial reference laboratory.
The test covers 22 clinically relevant genes; 46 clinical samples can be batched on a single MiSeq Dx run within 48 hours, the company said.
Under a partnership agreement signed last year, Pillar Biosciences, based in Natick, MA, is making its targeted NGS assays available as part of Illumina's portfolio of oncology products.
“This approach demonstrates our commitment to bringing highly accurate, actionable, and reimbursable NGS testing to clinical laboratories and biopharmaceutical companies to help improve treatment decisions and deliver outcomes that are accessible to everyone, everywhere,” said Gang Song, founder and executive chairman of Pillar Biosciences.
Kevin Keegan, general manager of oncology at Illumina, said, “Broadening the market for tumor profiling and therapy selection options is a key enabler of precision medicine and harnesses the power of the genome to improve human health.”
