Posted by Michael Wonder on 05 Aug 2021
Pillar Biosciences receives premarket approval from FDA for its oncoReveal Dx lung and colon cancer assay
5 August 2021 - Pillar Biosciences today announced the U.S. FDA has given premarket approval to its oncoReveal Dx Lung and Colon Cancer Assay, an next generation sequencing tissue based companion diagnostic test for the qualitative detection of somatic mutations in DNA derived from non-small cell lung cancer and colorectal cancer tumours.
The oncoReveal Dx Lung and Colon Cancer Assay premarket approval was based on clinically validated data, and allows for the test to be used as a companion diagnostic for all FDA approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor therapies for non-small cell lung cancer targeting EGFR mutations (exon 19 In frame deletions and exon 21 L858R substitution mutations), and KRAS wild type tumour tissue (absence of mutations in codons 12 and 13) for metastatic colorectal cancer patients, guiding clinicians where targeted treatment with Erbitux (cetuximab) or Vectibix (panitumumab) is warranted.
