NATICK, Mass. & SHANGHAI– Pillar Biosciences, an innovative next-generation sequencing (NGS) solutions in-vitro diagnostics (IVD) company, today announced the U.S. Food and Drug Administration (FDA) has given Premarket Approval (PMA) to its oncoReveal™ Dx Lung and Colon Cancer Assay, an NGS tissue-based companion diagnostic test for the qualitative detection of somatic mutations in DNA derived from non-small cell lung cancer (NSCLC) and colorectal (CRC) cancer tumors.
The oncoReveal™ Dx Lung and Colon Cancer Assay PMA was based on clinically validated data, and allows for the test to be used as a companion diagnostic (CDx) for all FDA approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapies for NSCLC targeting EGFR mutations (Exon 19 In Frame Deletions and Exon 21 L858R Substitution Mutations), and KRAS wild-type tumor tissue (absence of mutations in codons 12 and 13) for metastatic colorectal cancer (mCRC) patients, guiding clinicians where targeted treatment with Erbitux® (cetuximab) or Vectibix® (panitumumab) is warranted. This panel is intended to be used on the Illumina MiSeq™ Dx instrument, Illumina’s NGS platform for in vitro diagnostic testing.
“We are committed to providing high quality and accurate IVD tests to enable better treatment decisions for cancer patients,” said Gang Song, Ph.D., Founder and CEO at Pillar Biosciences. “Our FDA-approved product can be used by any lab that conducts NGS testing, making precision medicine accessible to all cancer patients.”
“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,” said Joydeep Goswami, Chief Strategy and Corporate Development Officer at Illumina. “We are committed to our ongoing partnership with the team at Pillar.”
“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,” said Zhaohui Wang, Ph.D., Co-founder and Chief Scientific Officer at Pillar Biosciences.
