Content not available in all countries.
Recent changes in health policies regarding molecular diagnostics, especially those involving infectious disease syndromic panels and PCR testing for infectious agents, have increased the challenges labs face when designing infectious disease molecular panels that are both clinically relevant and payor-supported.
As Marcus Cognetti, Co-Founder of national lab network P4 Diagnostix, explains in this webinar, reference labs and other testing facilities are now at an “inflection point” created by evolving guidelines, the end of the SARS-CoV-2 public health emergency, and diminished COVID-19 testing volumes. “There are labs like P4 that were in infectious disease and molecular testing beforehand, but there are many others afterwards that had spun up testing for COVID and are now looking or have been looking for new ways to utilize those testing platforms,” he said.
In the webinar, Cognetti is joined by Ari Frenkel, MD, Co-Founder and Chief Science Officer at Arkstone Medical Solutions, for an informative and topical discussion exploring how labs can best chart a path forward in this evolving regulatory landscape. The conversation covered how to review the existing clinical literature and guidelines, and gaps in clinical utility that will impact reimbursement.
Designing molecular panels to meet customer needs
When it comes to content selection, Cognetti recommends that labs begin by identifying their customer base. Then, they should pick markers and panels that are tailored to address the specific needs of these clients and the patient populations they serve.
“You can look at existing tests for guidance on where to start,” he explained. “But you need to design the test off of medical efficacy and understanding what the reimbursement landscape is going to be with your providers. Design it for the best outcome in terms of what that test result will look like.”
Building molecular panels is typically a complex process since content selection not only differs between diseases, but also depends on each lab’s capabilities and business goals. Cognetti says Diagnostix takes a multi-dynamic approach and is constantly adapting panels based on current markers, new and existing literature, and ongoing analysis of different modalities.
Growing importance of antimicrobial stewardship when selecting gene targets
The webinar also covered emerging concerns about antimicrobial resistance (AMR). As Dr. Frenkel points out, researchers estimate that in 2019 there were 4.95 million deaths associated with bacterial AMR, including 1.27 million deaths attributable to bacterial AMR—and that is more than the number of people who died from HIV/AIDS and malaria that year combined [1]. “Antimicrobial resistance is becoming a more central conversation,” Dr. Frenkel said. “It’s the silent pandemic.”
“Antimicrobial resistance is critical in healthcare. It’s going to affect our rates of hospital-acquired infections and admissions, and whether or not these infections are even treatable,” continued Dr. Frenkel. “We fear in the future that even the simplest infection could be impossible to treat due to antimicrobial resistance.” With increased awareness of the dangers of AMR, guidelines are beginning to change.
To help ensure antibiotics are tailored appropriately, “you almost want to design the panel backwards,” Dr. Frenkel explained. He suggests answering questions such as: What are we trying to diagnose? What are the most common microbes causing this? What are the most common associated resistances to those microbes? “Working from that side of the equation we often find is best to determine what to put on these panels,” he added.
To learn more about selecting relevant organisms and antimicrobial resistance gene targets for diagnostic testing, watch How to choose clinically relevant targets for your infectious disease panels on demand. The 60-minute webinar is full of practical advice to help labs navigate today’s clinical evidence requirements, assess emerging AMR concerns, and develop successful reimbursement strategies.
To learn more about Thermo Fisher Scientific’s infectious disease testing solutions, please visit here.