Randy Pritchard, Pillar Biosciences CEO, highlighted some of the progress the oncology solutions company has made in developing in-vitro diagnostics, in response to emailed questions from MedCity News.
Why did you join Pillar Biosciences?
I am incredibly impressed with the technology and the amazing team at Pillar that have done so much work to bring our oncoReveal™ Dx Lung and Colon Cancer Assay, a next generation sequencing (NGS), tissue-based companion diagnostic test to the market. Our FDA-approved product can be used by any lab that conducts NGS testing, making precision medicine accessible to all cancer patients. I’m also excited about our unique approach to the NGS market. Finally, I am incredibly impressed with our current investors, our world-class Board of Directors, and our Scientific Advisory Board.
What does the company do?
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.
What sets your company apart?
Pillar’s flagship technology, SLIMamp® target enrichment chemistry, enables automatable amplification of overlapping amplicons in a single tube from as little as 2.5ng DNA in less than 8 hours. Pillar’s complementary PiVAT® bioinformatics platform enables variant calling down to 1% VAF for virtually every type of variant with minimal computing resources and processing time.
For precision medicine to become widely accessible, pathologists need streamlined NGS workflows that deliver timely results, especially for first line cancer therapies. Pillar Biosciences’ technology and products focus on providing pathologists with productive solutions so that precision medicine can become the norm.
What specific need are you addressing in healthcare/life sciences?
We are working to make it possible to enable precision medicine to be first-line therapy for every patient with cancer, by bringing testing closer to the individual. Pillar is also addressing the significant cost burden of the current sequencing solutions through the application of our unique technology.
At what stage of development is your lead product?
OncoReveal™ Dx Lung and Colon Cancer assay is the first multi-cancer product to receive pre-market approval from the FDA. Our product is 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.
Do you have clinical validation for your product?
Absolutely. As part of our PMA application to FDA, we implemented a rigorous clinical validation protocol to assess the clinical performance of our oncoReveal™ Dx Lung & Colon Cancer Assay. A huge amount of FFPE tissue samples from CRC or NSCLC patients of different stages and age groups were included in our validation study. These samples came from several sites in the US, Australia and Europe to ensure our validation test covers various population.
Samples were tested in parallel at multiple US labs with our product and two other FDA-approved comparator assays. Results from all sites shows close to 100% clinical concordance between our oncoReveal™ Dx Lung & Colon Cancer Assay and the comparator assays. To confirm reproducibility of the assay, we also ran our validation test at multiple US sites (including industrial reference lab and academic medical centers), with 2 operators at each site performing independent testing on non-consecutive days. With our simple workflow and robust chemistry, 100% reproducibility was confirmed at all tests.
What are some milestones you have achieved?
We recently announced an agreement with Labcorp (NYSE: LH), a leading global life sciences company, 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.
We have also raised more than $85 million, most recently raising $20 million in a Series D round which closed in May of this year.
What’s next for the company this year?
We plan to expand the intended use of oncoReveal™ Dx Lung and Colon Cancer assay by preparing a supplemental filing for our PMA approval. We are also working to apply our proprietary technology for liquid biopsy therapy selection and tumor-informed disease monitoring.
At Pillar Biosciences, we believe high quality specialty tests should be provided closest to where a patient resides, especially for a cancer patient. We look forward to accelerating our future development plans and bringing more innovative FDA-approved products to the providers and partners in the community setting.
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.