Pillar Biosciences Seeks Precision Medicine as First-Line Treatment for Cancer Patients
Randy Pritchard, Biosciences pillar CEO, highlighted some of the progress the oncology solutions company has made in developing in vitro diagnostics, in response to questions emailed by MedCity News.
Why did you join Pillar Biosciences?
I am incredibly impressed with the technology and the amazing team at Pillar who have put in so much work to bring our oncoReveal™ Dx Lung and Colon Cancer Assay, a next-generation sequencing companion diagnostic (NGS) test on the market. Our FDA approved product can be used by any lab that performs NGS testing, making precision medicine accessible to all cancer patients. I am 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 providing in vitro diagnostics (IVD) that deliver accurate, robust, timely and clinically actionable information to guide treatment decisions across a patient’s continuum of care. We power the oncology ecosystem with our proprietary, automatable, platform-agnostic NGS, SLIMamp® and PiVAT® technologies with a streamlined workflow to accelerate the delivery of robust and reliable clinical test results. Our mission is to provide access to high quality, affordable, specialized NGS tests performed by any NGS lab as clinical grade tests, closer to home, for all patients.
What sets your business apart?
Pillar’s flagship technology, SLIMamp® target enrichment chemistry, enables automated amplification of overlapping amplicons in a single tube from 2.5 ng DNA in under 8 hours. Pillar’s PiVAT® Complementary Bioinformatics Platform makes it possible to invoke variants up to 1% VAF for virtually any variant type with minimal computing resources and processing time.
For precision medicine to become widely accessible, pathologists need streamlined NGS workflows that deliver rapid results, especially for first-line cancer therapies. Pillar Biosciences’ technology and products aim to provide pathologists with productive solutions so that precision medicine can become the norm.
What specific need do you meet in the field of health / life sciences?
We are working to enable precision medicine to be the first-line treatment for every cancer patient, bringing the tests closer to the individual. Pillar also addresses the significant financial burden of current sequencing solutions through the application of our unique technology.
What stage of development is your flagship product at?
The OncoReveal ™ Dx Lung and Colon Cancer Test is the first multi-cancer product to receive pre-market approval from the FDA. Our product is an NGS companion tissue diagnostic test for the qualitative detection of somatic mutations in DNA derived from non-small cell lung cancer (NSCLC) and colorectal cancer tumors (CRC).
Do you have clinical validation for your product?
Absoutely. As part of our PMA application to the FDA, we have 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 patients with CRC or NSCLC of different stages and age groups were included in our validation study. These samples came from multiple sites in the United States, Australia and Europe to ensure that our validation test covers diverse populations.
The samples were tested in parallel in several US laboratories with our product and two other comparison tests approved by the FDA. Results from all sites show close to 100% clinical agreement between our oncoReveal ™ Dx test for lung and colon cancer and comparison tests. To confirm the reproducibility of the test, we also performed our validation test at several US sites (including an industrial reference laboratory 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 in all tests.
What are the steps you have taken?
We recently announced an agreement with Labcorp (NYSE: LH), a leading global life sciences company, to provide genomic testing to people with cancer. Under the agreement, Pillar Biosciences will provide the oncoReveal ™ Essential Myeloproliferative Neoplasm (MPN) panel. Using NGS, the test simultaneously measures DNA mutations in multiple genes.
We also raised over $ 85 million, most recently $ 20 million in a Series D round that closed in May of this year.
What’s next for the company this year?
We plan to expand the intended use of the oncoReveal ™ Dx test for lung and colon cancer by preparing an additional dossier for our PMA approval. We are also working on the application of our proprietary technology for the selection of liquid biopsy therapies and tumor-based disease monitoring.
At Pillar Biosciences, we believe that high quality specialist testing should be provided closest to the patient’s place of residence, especially for a cancer patient. We look forward to accelerating our future development plans and bringing more innovative products approved by the FDA to suppliers and partners in the community.