COMPANY:

Pillar Biosci

"Pillar Biosciences, Inc...announced their receipt of the College of American Pathologists (CAP) Accreditation for its CLIA certified reference lab. As one of the most rigorous laboratory certifications, the CAP Accreditation is awarded to laboratories that meet stringent requirements and maintain the highest standards of laboratory quality, accuracy, and consistency."

"Beckman Coulter Life Sciences announced...that it has inked an application development agreement with Pillar Biosciences for next-generation sequencing solutions...Under the agreement, Pillar will develop applications designed for Beckman Coulter's Biomek NGenius System, an automated library preparation platform that includes a reagent input carousel, an integrated thermal cycler, and a labware transport system."

"Pillar Biosciences...announced that its oncoReveal Dx Colon Cancer Assay has received approval from the China National Medical Products Administration (NMPA). The IVD assay is now commercially available in China, the U.S., and Europe as a companion diagnostic (CDx) to identify patients with colorectal cancer whose tumors express wild-type KRAS status and may benefit from treatment with specific targeted therapies."

"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."

"Pillar Biosciences...announced that its abstract, 'Reducing Pre-analytical Sample QC Failure Rates for Cancer Molecular Genetic Assays with SLIMamp® Technology', has been published online in the Journal of Clinical Oncology, in conjunction with the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting...The study showed that oncoReveal™ Solid Tumor Panel with Pillar Biosciences’ proprietary SLIMamp® technology, was able to generate reliable, interpretable results for almost all of the samples that had failed pre-analytical QC for WES."

"Pillar Biosciences...announced the presentation of clinical validation data for the FDA-PMA1 approved oncoReveal Dx Lung & Colon Cancer Assay, along with three additional posters at the 2022 American Association for Cancer Research (AACR) Annual Meeting...Results demonstrate that oncoReveal Dx detects clinically significant variants (KRAS G12/G13, EGFR L858 and exon 19 deletion, and BRAF V600E) from as low as 10ng of DNA input with LoD between 1.5% and 2.6% (VAF, Variant Allele Frequency)."

"Pillar Biosciences...announced that its NGS laboratory, located in Natick, Massachusetts, has passed the onsite inspection and received Clinical Laboratory Improvement Amendment (CLIA) certification from the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS), as well as the Massachusetts state permit."

"Pillar Biosciences...announced that it has entered into an agreement with Labcorp...to provide genomic testing for people with cancer....Under the agreement, Pillar Biosciences will provide the oncoReveal™ Essential Myeloproliferative Neoplasm (MPN) panel. Using NGS, the test simultaneously measures for DNA mutations across multiple genes."

"Pillar Biosciences...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."