NEW YORK – Pillar Biosciences said Thursday that the US Food and Drug Administration has granted premarket approval for its OncoReveal Dx Lung and Colon Cancer Assay, a next-generation sequencing, tissue-based companion diagnostic test for the qualitative detection of somatic mutations in DNA from non-small cell lung cancer and colorectal cancer tissue samples.
OncoReveal Dx is an in vitro diagnostic kit that uses Pillar's amplicon-based target enrichment technology and is intended to be used on the Illumina MiSeq Dx instrument.
The PMA, issued July 30, provides for its use as a companion diagnostic to guide the use of FDA approved EGFR tyrosine kinase inhibitor therapies, such as cetuximab (Eli Lilly's Erbitux) and panitumumab (Amgen's Vectibix), in NSCLC and CRC patients in accordance with established drug labels.
"We believe high quality specialty tests should be provided closest to where a patient resides, especially for a cancer patient. We look forward to accelerating our future development plans and bringing more innovative FDA-approved products to the providers and partners in the community setting," Pillar CSO Zhaohui Wang said in a statement.
"Increasing patient access to content on our Dx instrument fleet through partnerships such as those with Pillar Biosciences speaks to our mission to improve human health by unlocking the power of the genome," added Joydeep Goswami, Illumina's chief strategy and corporate development officer.