TEST:

Pan-cancer OncoReveal™ CDx

oncoReveal CDx pan-cancer solid tumor IVD is a rapid and robust kitted assay for the detection of >3,660 CDx and tumor profiling variants in 22 genes. Given the FDA's recent Final Rule on laboratory-developed tests, oncoReveal CDx will be an attractive FDA-approved kitted option for laboratories and pharma partners to quickly assess key oncogenic driver genes for multiple solid tumor types.

As with all assays, this test has its benefits and limitations. A primary benefit is the speed and relative ease of performance. Library preparation is scalable for 6 to 48 samples and can be completed in a day.

We will also review Molecular Pathology Laboratory Network, Inc. (MPLN) experience and data associated with verifying this IVD for clinical and biopharma use.

"Pillar Biosciences, Inc., the leader in Decision Medicine, has announced that Molecular Pathology Laboratory Network, Inc., (MPLN) is now the first national molecular reference laboratory to verify and launch oncoReveal CDx. 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)."

"Pillar Biosciences, Inc...announced that the U.S. Food and Drug Administration (FDA) has approved the company's Premarket Approval (PMA) supplement application for its oncoReveal CDx pan-cancer solid tumor in vitro diagnostic (IVD). The approval expands the indication of oncoReveal Dx from EGFR & KRAS therapy selection in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) to now include general solid tumor profiling."

"Pillar Biosciences...announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Premarket Approval (PMA) supplement application for its Pan-cancer oncoReveal™ CDx. The supplement, if approved, will expand the label/indication of Pillar Bioscience’s oncoReveal™ Dx Lung & Colon Cancer Assay to include actionable targets for eight additional cancer types, bringing the total detectable cancers to ten."