Our journey to win the Prize: Lessons and road ahead

27 Sep 2016
Written by
Dr. Robert Sambursky
RPS Diganostics' FebriDx diagnostic test

Dr. Robert Sambursky is the Founder, Chief Executive Officer, and President of RPS Diagnostics, the developer of the revolutionary FebriDx® test. He earned his BA from Brown University, MA from Boston University, and MD from Boston University School of Medicine and he is an expert in diagnostic testing for inflammatory and infectious diseases.  

Why the Longitude Prize?

RPS Diagnostics is a small company based out of Sarasota, FL, applying for arguably the most esteemed healthcare prize in the world because we’re on a mission, poised and ready to tackle the biggest health challenge facing the world today: antibiotic overuse and resistance. And we’re confident we have the right diagnostic tool to do it, available now. What we’ve learned is development is just the first step in the start of a long road ahead.

It starts with the technology.

At RPS, we have what we believe to be a breakthrough innovation called FebriDx®, a test that not only identifies a clinically significant acute respiratory infection but also aids in the differentiation of viral from bacterial infection in as soon as 15 minutes.

FebriDx requires only a fingerstick blood sample and both the patient and the healthcare provider have results almost immediately. That means patients have a diagnosis and an accurate treatment plan before even leaving the doctor’s office or community clinic, taking the guess work out of whether or not a patient needs an antibiotic.

As a practicing physician, I understand the value of a quick and precise diagnostic to guide therapeutic decision-making.

Next, is your diagnostic relevant globally? And how do you drive regulatory approvals worldwide?   

The World Health Organization, The Review on Antimicrobial Resistance, President Obama’s administration, and countless other government and advocacy groups have declared antibiotic overuse and resistance the greatest global health threat. It was also voted for by the UK public as the topic for the elusive and esteemed Longitude Prize. Zika in the Americas and the spike of MERS and Dengue Fever in the Middle East mean a test like FebriDx is key in preventing the spread of disease and reducing antimicrobial resistance.

We know the world needs it. How do we make sure patients have access? Most diagnostic companies fail because of the inability to obtain regulatory approvals and designations (such as a CLIA waiver). FebriDx overcame the years-long road of regulatory hurdles, securing CE mark in Europe, Health Canada approval, and clearance in Saudi Arabia and Singapore. Plus, FebriDx is currently in U.S. FDA clinical trials. The road continues as we work to extend our reach and access to our test everywhere.

But is it enough to have a revolutionary technology that can potentially solve the world’s biggest health challenge and is commercially available in many parts of the world? Not even close...

The hurdles continue. We’ve developed and manufactured the product. We’ve adhered to the WHO Assured Criteria. We’ve established the clinical need and gathered data from clinical trials. We’ve worked to elevate the visibility of FebriDx by educating key stakeholders about its clinical differentiation. We’ve garnered some high-profile advocates, including Homeland Security (U.S.), which helped fund FebriDx’s development, and government agencies and ministries of health in different parts of the world—including recognition from the Longitude Committee. It’s taken us, from concept to commercialization, almost 7 years to get to this moment. It’s a mission, a personal and company-wide commitment.

If I talk to anyone—investors, doctors, government agencies, customers—the one question I consistently get is:  What do you need now for FebriDx to succeed and to benefit as many patients as possible?

The answer is REIMBURSEMENT. The next major hurdle is payment for the test. While physicians and institutions understand the importance of driving antibiotic stewardship and want to do the right thing for their patients, the reality is they will not implement a test based on a clinical benefit alone.

Reimbursement is the true path to adoption of a new diagnostic tool.

And to drive reimbursement you need government support. You need clinical approval from government experts and key opinion leaders (KOL) within the field. To get those KOLs onboard you need a rigorous prospective multicenter clinical trial—and maybe more.

Depending on region, KOLs may insist on implementing a new clinical trial specific to their region (at your expense). You need access to national health services and ministries of health. You need support from clinical guidelines authors and researchers.

All of these groups need more than education. They need to believe. And to make them believers, you need to link the public health need, AMR, to the cost-effective, proven solution.

Our Longitude Journey…continues?

We submitted an application to win the Longitude Prize for the 31 May deadline. We learned soon after that we wouldn’t be moving on to the next round. 

It’s sincerely one of the most disappointing calls we’ve received, but we’re proud to be among only a handful of entrants from the U.S. and we’re even more emboldened by the feedback we’ve received from members of the Longitude review team.

Don’t count us completely out of the race just yet. While our current FebriDx test is commercially available today for primary and urgent care outpatient settings worldwide, our test doesn’t yet have the ability to be used over-the-counter (OTC) or as a home-based test. However, our second generation FebriDx test should meet that Longitude Prize OTC requirement, and we may just be ready to apply again before the final deadline comes around in 2019.

Congratulations to each of the remaining hopefuls. It’s truly an honor to be in the company of such a strong group of contenders with the shared mission of reducing antibiotic overuse and resistance.

Learn more about FebriDx.

RPS Diagnostics is registered team competing for the Longitude Prize.