Randy Pritchard Pillar Biological Sciences The CEO, in answering MedCity News’s email question, highlighted some of the progress that Oncology Solutions has made in the development of in vitro diagnostics.
Why did you join Pillar Biosciences?
Pillar’s technology and excellent team have left a deep impression on me. They have done a lot of work to bring us Tumor display™ Dx Lung and Colon Cancer Test, a market-oriented next-generation sequencing (NGS), tissue-based companion diagnostic test. Our FDA-approved products can be used by any laboratory that conducts NGS testing, enabling all cancer patients to receive precision medicine. I am also excited about our unique approach to the NGS market. Finally, our current investors, our world-class board of directors and scientific advisory committee left a very deep impression on me.
What does the company do?
Pillar Biosciences is a global oncology solutions company that provides in vitro diagnostics (IVD), providing accurate, reliable, timely, and clinically actionable insights to guide patients’ treatment decisions throughout the care process. We power the tumor ecosystem through our proprietary, automatable, NGS platform-agnostic, SLIMamp® and PiVAT® technologies, and accelerate the delivery of robust and reliable clinical test results through simplified workflows. Our mission is to enable all NGS laboratories to provide all patients with high-quality and affordable professional NGS testing as clinical-level testing closer to home.
Randy Pritchard
What makes your company unique?
Pillar’s flagship technology SLIMamp® targeted enrichment chemistry can automatically amplify overlapping amplicons from as low as 2.5 ng DNA in a single tube in less than 8 hours. Pillar’s supplementary PiVAT® bioinformatics platform can implement variant calls as low as 1% VAF for almost all types of variants with minimal computing resources and processing time.
To make precision medicine widely available, pathologists need a simplified NGS workflow to provide timely results, especially for first-line cancer treatments. Pillar Biosciences’ technology and products focus on providing pathologists with efficient solutions, making precision medicine the norm.
What are your specific needs in the healthcare/life sciences field?
We are working hard to make precision medicine the first-line treatment for every cancer patient by bringing detection closer to the individual. Pillar also uses our unique technology to solve the huge cost burden of current sequencing solutions.
At what stage of development is your leading product?
OncoReveal™ Dx lung and colon cancer test is the first multi-cancer product to receive pre-market approval from the FDA. Our product is a companion diagnostic test based on NGS tissue for the qualitative detection of somatic mutations in DNA derived from non-small cell lung cancer (NSCLC) and colorectal (CRC) cancer tumors.
Is your product clinically validated?
Absolutely. As part of submitting a PMA application to the FDA, we implemented a rigorous clinical validation protocol to evaluate the clinical performance of our oncoReveal™ Dx lung and colon cancer test. Our validation study included a large number of FFPE tissue samples from CRC or NSCLC patients of different stages and age groups. These samples come from multiple locations in the United States, Australia, and Europe to ensure that our verification tests cover different populations.
The samples were tested in parallel in multiple US laboratories using our product and two other FDA-approved comparative analyses. The results of all sites show that the clinical agreement between our oncoReveal™ Dx lung and colon cancer test and the comparative test is close to 100%. In order to confirm the repeatability of the test, we also conducted verification tests at multiple U.S. sites (including industrial reference laboratories and academic medical centers), and 2 operators at each site conducted independent tests on discrete days . With our simple workflow and robust chemical reaction, 100% reproducibility has been confirmed in all tests.
What are your milestone achievements?
US Recently announced an agreement with Labcorp (NYSE: LH), a leading global life science company, provides genomic testing for cancer patients. According to the agreement, Pillar Biosciences will provide oncoReveal™ Essential Myeloproliferative Neoplasm (MPN) panel. Using NGS, this test can measure DNA mutations in multiple genes at the same time.
We also raised more than US$85 million, and recently raised US$20 million in the D round of financing that ended in May of this year.
What is the next step for the company this year?
We plan to expand the intended use of oncoReveal™ Dx lung and colon cancer testing by preparing supplementary documents for our PMA approval. We are also committed to applying our proprietary technology to liquid biopsy therapy selection and tumor-related disease monitoring.
At Pillar Biosciences, we believe that high-quality professional testing should be provided in the place closest to the patient’s place of residence, especially for cancer patients. We look forward to accelerating our future development plans and bringing more innovative FDA-approved products to suppliers and partners in the community environment.
