NATICK MASSACHUSETTS, Nov. 29, 2017 /PRNEWSWIRE/ – Pillar Biosciences, Inc. a manufacturer of precision next-generation sequencing (NGS) panels and software solutions for robust and cost-effective clinical sequencing, announces it has received ISO 13485:2016 certification for design, development, manufacture, and distribution of products for the clinical oncology laboratory within a comprehensive quality management system (QMS). The first Pillar Biosciences assay produced under this QMS is the recently-launched ONCO/Reveal BRCA 1/2 panel targeting the entire coding region of the BRCA genes. All current products are based upon Pillar Biosciences’ patented SLIMamp™ targeted sequencing technology platform and proprietary PiVAT™ analytics software. While current products are for research use only (RUO), Pillar intends to file selected targeted NGS panels with proven clinical utility for regulatory approval.
The ISO 13485:2016 certificate was issued to Pillar Biosciences by Intertek on November 24, 2017. Pillar Biosciences’ Quality Management System will assure the quality and efficacy of its products and services in accordance to applicable regulatory and statutory requirements.
Gang Song, Ph.D., CEO, stated “Pillar Biosciences is enabling affordable precision medicine by producing products for the clinical NGS laboratory that are accurate, streamlined, reliable and cost-effective. Our customers can be confident that Pillar Biosciences’ future RUO and Illumina MiSeq™ Dx in vitro diagnostic products are developed, manufactured, and distributed under the most recent quality standards.”
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About Pillar Biosciences Research Panels
Research-use-only (RUO) panels sold by Pillar (including the ONCO/Reveal Solid Tumor Panel) are neither intended for use in clinical investigations or diagnosis, nor are they intended for validation as laboratory developed tests. Pillar Biosciences does not assist in performing validation or verification of test performance for clinical diagnostic use.
About Pillar Biosciences
Pillar Biosciences is a clinical cancer diagnostics company based in Boston, Massachusetts and Shanghai, China. Our automatable variant detection technologies deliver robust results with rapid turnaround times through streamlined NGS workflows. Today, our SLIMamp®- and PiVAT®-based products help high-throughput laboratories boost their research productivity. Regulatory approval for clinical panels is pending.