Output from a DNA sequencer. [Image courtesy of National Human Genome Research Institute]
The concept of “locality” differentiates a business or company and conveys its value. Phrases like “shop local,” “locally sourced” or “local place” demonstrate the importance of something that doesn’t require significant time, travel or expense, offers convenience and is trustworthy. Locality breeds familiarity and comfort, particularly in healthcare, where it can heavily influence decisions. Patients trust local physicians. Those physicians have faith in local laboratories where they conduct tests and send samples for analysis. The ability to say something is “local” is important in healthcare decisions because time and resources are minimized when consultations, procedures, and tests are done in familiar venues, in close proximity to patients.
For people battling cancer, the concept of locality is essential. Local oncologists, local treatment centers, and local support networks are of the utmost importance. Locality also affects the speed at which diagnosis is confirmed and treatment is initiated. Until recently, targeted therapies were selected based on results of Next Generation Sequencing (NGS) tests performed at large, central laboratories. These tests are not easily accessible, expensive and entailed extended wait times – approximately three weeks – to deliver critical genetic data to physicians who use the results to inform treatment decisions. Additionally, the risk of a lost, mislabeled, damaged or inadequate samples meant the process may need to be repeated, further delaying the matching of the ideal medication to patients. These needless, avoidable barriers compound fear and anxiety for patients, and negatively impact the entire healthcare ecosystem. But what if those three weeks could be reduced to as little as 48 hours?
Despite the importance of NGS test data, a substantial unmet need remains for tests that can be done quickly, conveniently, and cost-effectively, and produce accurate results regardless of sample size or integrity. The NGS cancer testing market will reach $110 billion in the United States by 2030, and more than three quarters (75.6%) of oncologists reported using NGS tests to guide treatment decisions or identify patients eligible for pharmaceutical clinical trials for new therapies.
Improvements in testing accessibility, affordability, and accuracy can alleviate some of the financial, physical, and emotional burdens of cancer treatment, and bring peace of mind to patients who know their treatment journey can begin faster. Working to overcome inefficiencies in the NGS testing process isn’t a new endeavor, however the solution isn’t to just scale up the size of testing facilities, nor is it to only focus on one aspect of the process, such as cost or expedience.
The cause of the majority of challenges can be addressed the same way companies improve connections to customers – by enhancing locality. A localized approach can revolutionize NGS testing – from sample collection, library preparation, to sequencing, data analysis, and reporting. Bringing testing into local hospitals and clinics can minimize time needed to provide the data required to make prescribing decisions that may improve patient outcomes.
The means to localize NGS testing lies in improving the technology that powers the test. Pillar Biosciences is pioneering a concept called Decision Medicine, which is the utilization of highly accurate and sensitive NGS testing technology to generate data that optimizes selection of precision therapies, from tumor profiling to therapy selection, and recurrence monitoring.
Decision Medicine is possible due to a simple, yet robust NGS technology called SLIMamp, a complementary, AI-enabled, VersaTile primer design algorithm, and the PiVAT data analysis software platform. These are FDA-cleared, and CE marked for clinical use, in the United States and Europe respectively, with NMPA approval pending in China, to seamlessly integrate NGS testing into any pathology lab with a sequencer. Clinical studies have shown SLIMamp assays enable pathologists to achieve accurate, actionable data in as little as 48 hours, allowing physicians to quickly select appropriate therapies and conduct post-treatment monitoring.
NGS testing with SLIMamp technology detects clinically relevant mutations and variants by inhibiting amplification of inconsequential regions of the gene early in the library preparation. This enables examination of thousands of genetic targets in one reaction tube (versus others requiring multiple tubes), and requires fewer patient samples, resulting in an improved patient experience, and a more accurate, timely, and cost-effective result.
By localizing NGS testing and bringing it into easily accessible community facilities, and simplifying the workflow, pathologists have a more efficient path to generate accurate, actionable data. Studies expected to be published in 2022 will demonstrate that Pillar’s cfTNA assay achieves better sensitivity on low volume samples than a competitive assay on three gene variants or mutations that are commonly associated with non-small cell lung cancer diagnosis (ex19Del; L858R; T790M). In addition, Pillar’s to-be-released cfTNA core panel targets and reports variants and mutations on 106 genes, which exceeds a competitor’s offering that only reports 55 gene targets.
This improved locality and accuracy creates an economically feasible ecosystem, resulting in enhanced access and expedited treatment, which may reduce overall cost-burden on the healthcare system. These cost-efficiencies have been demonstrated via comparative analyses between commercially-available NGS tests. The overall economic and operational efficiency driven by this type of streamlined workflow allows NGS testing to be localized by any CLIA-certified laboratory.
Empowering treatment decisions through testing across the entire healthcare journey for everyone, everywhere, is the mission of Pillar and the core of its commitment to Decision Medicine. The Company has more than 20 IVD or RUO NGS testing products, and several others in various stages of development, including a pan-cancer oncoReveal CDx assay, and two liquid biopsy offerings.
Randy Pritchard is the chief executive officer of Pillar Biosciences. Zhaohui Wang, Ph.D. is the company’s chief scientific officer.