An interview with Stephen Miller, Chief Commercial Officer: Why collaboration is the key to innovation

What is Biofidelity’s approach to collaboration?

Biofidelity aims to increase awareness of our company, technology and products via our collaborations. We’re working with partners to aid in our mission of making genomic analysis simpler and more efficient to unlock its full potential, and we are now working to expand this mission with new collaborations. For ASPYRE-Lung®, we aim to partner with institutions and organizations who share our goal of promoting research to identify patients with non-small cell lung cancer biomarkers much faster and more cost-effectively, so more patients may receive the most appropriate therapy as soon as possible after diagnosis.

Why are partners interested in collaborating with us?

Early collaborators have an opportunity to remain on the cutting edge of novel technologies by participating in research to bring new products to market to better serve patients. They want to establish ways to get patients on optimal therapies expediently. ASPYRE-Lung is being developed to address a fundamental problem with lung cancer treatment by bringing testing closer to the patient and returning results far more quickly. This is of significant interest to the market and to researchers at cancer centers. The ASPYRE® technology fills a significant gap in the market, and provides an alternative to expensive and time-consuming multi-gene testing options.

Who does Biofidelity currently collaborate with? 

We are working with a number of leading cancer centers to generate and publish data using our technology. We are also using these relationships to obtain feedback on product performance and workflows from beta testing, and have used this to improve the user-friendliness of our products. Many of the institutions we are working with have internalized next-generation sequencing (NGS), but have a significant issue with turnaround time and costs, with results taking several weeks to return. Even some of the most rapid labs take at least one week, but more likely two to four weeks. Because of these long timelines, often prescribing physicians at a local level don’t have an appropriate treatment to recommend for those patients even if they are eligible for targeted therapy. These labs are seeking a rapid, clinically actionable panel alternative to NGS to expedite patient treatment plans.

How are we successful in our collaborations?

We aim to ensure that all of our partners benefit from working with us, feel supported, and that our collaborations deliver real value both to our partners and, in the future, to the patients they serve. We work hard to set our partners up for success and, in turn, we learn the ideal process, instructions for use, easy setup of the assay internally, staff training, and the most appropriate equipment to use. After identifying the elements to optimize performance, our product becomes more scalable. We’re then able to approach institutions that potentially don’t have the same level of expertise available to run the assay.

What feedback are we getting from our current partners?

The initial feedback is that the assay is straightforward to run, and the product is meeting our targets specifications and sensitivity levels. We can perform testing on lower amounts of input DNA, and the software that interprets the data is working as intended. During set-up, our team works hard to ensure that our partners are thoroughly trained on the assay to ensure that they feel comfortable working with the simple workflow and robust ASPYRE technology.

How can collaborations help overcome some of the barriers that exist for biomarker testing? 

Biofidelity’s CAP/CLIA laboratory in North Carolina can perform ASPYRE-Lung testing for clinicians and hospitals with a two-day turnaround time. Through our collaborations, we are enabling our partners to implement ASPYRE-Lung for research use on their existing PCR instruments, allowing them simple, cost-effective access to rapid genomic analysis. Ultimately, our goal is to enable the decentralization of precision genomic testing, allowing far more patients to access the vital information needed for optimal cancer care. Currently, testing access and reimbursement pose major problems. Many US payers only want to pay for actionable tests. There’s a significant amount of information in NGS reports that’s irrelevant for lung cancer care. Our ASPYRE-Lung assay examines only relevant and actionable genes from NCCN guidelines and runs on a standard real-time PCR platform, the standard for PCR COVID-19 testing. Well-proliferated and underutilized PCR equipment in institutions presents a global opportunity to bring testing closer to patients without the enormous up-front investment required with NGS.

What should people/organizations do if they want to collaborate with us?

If anyone has interest in working with Biofidelity, they should reach out via our website or to our BD team at BD@biofidelity.com, and we can discuss potential collaborations.

For research use only