Pillar Biosciences Presents New Clinical Validation Data Confirming the Accuracy of its oncoReveal™ Dx Lung & Colon Cancer Assay in Detecting Clinically Relevant Variants

– Laboratory and software validation testing determined ability to accurately identify key companion diagnostic targets within KRAS and EGFR genes, and specify associated approved therapy

– These data, plus three additional studies, presented at the 2022 American Association for Cancer Research (AACR) Annual Meeting

NATICK, Mass. – April 11, 2022 – (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 oncoRevealTM 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 oncoRevealTM 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 oncoRevealTM MSI panel”, investigators evaluated the oncoRevealTM 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.

Investor Contact:
Dawn Schottlandt
Argot Partners
212-600-1902
Pillar@argotpartners.com

Media Contact:
Joshua R. Mansbach
Argot Partners
212-600-1902
Pillar@argotpartners.com

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