FDA Accepts Review for Pillar Bioscience’s Pan-Cancer oncoReveal™ CDx

The FDA accepted review for the premarket approval supplement application for the Pan-cancer oncoReveal™ CDx.

The FDA has accepted the review for the premarket approval (PMA) supplement application for the Pan-cancer oncoReveal™ companion diagnostic (CDx), according to Pillar Biosciences.1

If the FDA approves, the supplement’s label/indication will expand Pillar Biosciences’ oncoReveal™ Dx Lung & Colon Cancer Assay to include actionable targets for another 8 cancer types, summing the totable detectable cancers to 10 types.

"We are pleased to take the next step towards expanding the clinical utility of the oncoReveal™ Dx, which is the first FDA-approved multi-cancer in vitro diagnostics launched in the market," said Randy Pritchard, chief executive officer of Pillar Biosciences, in the press release. "With our innovative technology platform, we built an assay with extraordinary sensitivity, simple workflow, and fast turnaround time to enable localized testing that can be performed in any next-generation sequencing lab [NGS], whether hospital-based or a commercial reference laboratory. This localized approach demonstrates our commitment to bringing highly accurate and actionable NGS testing to clinical laboratories and biopharmaceutical companies in order to help improve treatment decisions and outcomes that are accessible to everyone, everywhere.”

Covering 22 clinically relevant geneses in 1 multiplex reaction, the panel provides comprehensive genomic results and has an automatable workflow that can be executed with a sample-to-report time of 48 hours in any clinical laboratory.

The PMA supplement application follows the original PMA approval of oncoReveal™ Dx Lung & Colon Cancer Assay in July 2021, for the use of FDA approved EFGR tyrosine kinase inhibitor therapies in non—small cell lung cancer (NSCLC) and colorectal cancer (CRC).2

Pillar’s oncoReveal™ Dx Lung & Colon Cancer Assay is an NGS-based CDx kit to guide prescription of CRC-targeted therapies such as cetuximab (Erbitux) and panitumumab (vectibix), as well as NSCLC-targeted therapies, including erlotinib (Tarceva), afatinib(Gilotrif),gefitinib(Iressa), and dacomitinib (Vizimpro).

The assay covers the KRAS wildtype for CRC in the absence of mutations in codons 12 and 13 and the EFGR gene in NSCLC for exon 19 deletions and exon 21 L858R.3

"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," stated Zhaohui Wang, chief sales officer for Pillar Biosciences, in a press release.

"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, the chief strategy and corporate development officer at Illumina, in another press release.

Pillar biosciences announces U.S. food and drug administration acceptance of premarket approval (PMA) supplement application for pan-cancer oncoreveal™ CDx. Press release. Yahoo Finance. July 19, 2022. Accessed July 20, 2022. https://yhoo.it/3zlIYnK
Pillar biosciences receives fda approval for oncoreveal dx lung and colon cancer assay. Precision Oncology News. August 5, 2021. Accessed July 20, 2022. https://bit.ly/3ziLMSD 
Pillar® oncoReveal™ Dx lung and colon cancer assay. Product sheet. Accessed July 20, 2022. https://pillarbiosci.com/wp-content/uploads/2021/07/MK-0027-2-IVD-Product-Sheet-EU.pdf