On July 30, 2024 Pillar Biosciences, Inc., the leader in Decision Medicine, reported that Molecular Pathology Laboratory Network, Inc., (MPLN) is now the first national molecular reference laboratory to verify and launch oncoReveal CDx (Press release, Pillar Biosciences, JUL 30, 2024, View Source [SID1234645179]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The oncoReveal CDx pan-cancer solid tumor IVD kit has been FDA PMA approved for general tumor profiling for 22 clinically relevant genes across all solid tumors, including CDx claims for KRAS (Erbitux & Vectibix) in colorectal cancer (CRC) and EGFR (TKI Class Approval) in non-small cell lung cancer (NSCLC). oncoReveal CDx has a rapid single-day workflow that can be performed by any clinical laboratory enabled with an Illumina MiSeq Dx platform with an integrated sample-to-report time of as little as 48 hours. Up to 46 clinical samples can be performed on a single MiSeq Dx run.

"We are proud to partner with Pillar Biosciences on the global launch this important IVD assay kit," said Dr. Roger Hubbard, Ph.D., Chief Executive Officer, Molecular Pathology Laboratory Network. "MPLN’s goal is to bring innovative technologies to diagnostic care and clinical trial studies. We see this diagnostic assay as an important clinical tool to help quickly select certain cancer patients for 1st line targeted therapy or clinical trials. Given this assay was an FDA approved kit, our laboratory team was quickly able to perform full IVD assay verification within 2 weeks of training. We look forward to working with our physician network and biopharma partners to implement this new solid tumor IVD product."

"The potential of increased FDA regulation on LDTs is putting immense pressure on CLIA-certified molecular reference laboratories," said Dan Harma, Chief Commercial Officer, Pillar Biosciences. "The launch of our oncoReveal CDx now enables these laboratories with an FDA approved solid tumor assay which can be quickly and easily verified and performed in any laboratory with an Illumina MiSeq Dx NGS platform to rapidly profile patients with solid tumors. We see this as a great opportunity to improve care and reduce the delay in patients receiving targeted therapy."