NATICK, Mass.--(BUSINESS WIRE)--Pillar Biosciences, an innovative, next-generation sequencing (NGS) solutions, in-vitro diagnostics (IVD) company, today 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 of the validation study of Pillar’s oncoReveal™ Dx Lung & Colon Cancer Assay established that this FDA-approved IVD assay can accurately identify key companion diagnostic targets,” said Helen Fernandes, Ph.D., Professor of Pathology at Columbia University Medical Center. “These findings are important, as they enable clinicians to confidently use results from the oncoReveal™ Dx test to inform therapeutic decisions, helping patients begin their treatment journey with confidence that their physician has selected the appropriate treatment for the specific cancer.”
The validation study was conducted using various DNA input amounts between 5-160ng, from Formalin-Fixed Paraffin-Embedded (FFPE) tumor tissues. 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). In addition, across 263 clinical samples, positive percent agreement (PPA) and negative percent agreement (NPA) between oncoReveal™ Dx and an externally validated comparator were >99% each. For reproducibility, the average percent positive agreement (APA) and average percent negative agreement (ANA) were each >95%. These results show that oncoReveal™ Dx is highly accurate for the detection of clinically relevant variants and specification of associated approved therapy, and can accurately identify key companion diagnostic targets within KRAS and EGFR genes, as well as additional variants outside the companion diagnostic targeted list.
“The collective data presented at AACR adds to the robust body of evidence supporting the accuracy and efficiency of Pillar’s suite of diagnostic testing solutions,” said Randy Pritchard, CEO of Pillar Biosciences. “We believe that by decentralizing NGS testing and providing physicians with actionable, highly accurate genetic data in as little as 48 hours, we can significantly optimize selection of precision therapies to treat various cancers. We are pleased to share these data with the industry and to continue developing our NGS test portfolio in order to help make the selection of an appropriate therapy a more efficient process for the oncology community.”
Three additional posters were presented at AACR. These studies were designed to support the technology of Pillar’s NGS testing platform. In a poster entitled “Single tube PCR-based NGS assay for detection of multiple gene fusions from cell free total nucleic acid”, results demonstrated that Pillar’s single tube assay successfully detected fusion from cfRNA down to 0.5% VAF, and had over 99% sensitivity and specificity down to 4% VAF with as low as 10ng of DNA input. In the poster entitled, “Accurate detection of microsatellite instability (MSI) in matched and unmatched clinical tumor samples using the Pillar oncoReveal™ MSI panel”, investigators evaluated the oncoReveal™ MSI Panel’s accuracy in the detection of tumor microsatellite instability (MSI) status without a matched normal tissue comparator, and found that results were comparable to the normal matched tissue context. The company also presented data on the accurate detection of tumor sequence of low tumor content samples in MRD monitoring, in a study entitled, “Accurate detection of tumor sequence at low tumor content for MRD”.
The four posters are available in the “Posters” section of the company’s website at www.pillar-biosciences.com/our-presence/.
Poster Presentation Details
Abstract 5795: Validation of FDA approved oncoReveal Dx lung and colon cancer assay (oRDx-LCCA)
Date/Time: Friday, April 8, 2022, 12:00 PM - 1:00 PM ET
Session: Genomics
Session Type: E-Poster Session
Presenter: Gloria Chan Johnson
Abstract 5996: Single tube PCR-based NGS assay for detection of multiple gene fusions from cell free total nucleic acid
Date/Time: Friday, April 8, 2022, 12:00 PM - 1:00 PM ET
Session: Metastasis
Session Type: E-Poster Session
Presenter: Tejashree Modak
Abstract 5694: Accurate detection of microsatellite instability (MSI) in matched and unmatched clinical tumor samples using the Pillar oncoReveal MSI panel
Date/Time: Friday, April 8, 2022, 12:00 PM - 1:00 PM ET
Session: DNA Damage and Repair
Session Type: E-Poster Session
Presenter: Jordan Aldersley
Abstract 5066: Accurate detection of tumor sequence at low tumor content for MRD
Date/Time: Friday, April 8, 2022, 12:00 PM - 1:00 PM ET
Session: Convergence Science and Systems Biology
Session Type: E-Poster Session
Presenter: Andrew Conley
About Pillar Biosciences
Pillar Biosciences is a global oncology solutions company delivering in-vitro diagnostics (IVD) that provide accurate, robust, timely, clinically actionable insights to guide treatment decisions throughout a patient’s continuum of care. We power the oncology ecosystem with our proprietary, automatable, NGS platform agnostic, SLIMamp® and PiVAT® technologies with a simplified workflow to expedite the delivery of robust and dependable clinical test results.
Our mission is to enable access to high quality, affordable, specialty NGS testing, performed by any NGS laboratory as clinical grade tests, closer to home, for all patients. Pillar has operations in Natick, MA and Shanghai, China. For more information, visit www.pillar-biosciences.com.
