Josh Griffith is vice president of global marketing for Luminex Corporation, which develops, manufactures, and markets biological testing technologies in the clinical diagnostic and life science industries. Over his nearly 10 years at Luminex, he has held multiple marketing and business management roles. Before joining the company, Josh spent eight years in sales management at companies including Roche Diagnostics and Forest Pharmaceuticals. He received his bachelor’s degree from Drew University in Madison, NJ.
As we brace for the peak of what could be a worse-than-usual flu season amidst the COVID-19 pandemic, the importance of syndromic testing for respiratory infections is clear. Unfortunately, panel-based molecular diagnostic testing has been a mixed blessing for clinical laboratories.
While syndromic testing for a series of common infections with overlapping symptoms significantly accelerates a lab team’s ability to get actionable answers to physicians in a clinically relevant time frame, insurance companies have been less enthusiastic about their use.
Typically, reimbursement is straightforward for single-target tests. For panel-based tests, though, the reimbursement landscape has evolved rapidly and it can be challenging for labs to keep up. Teams must strike a balance between generating broader results more rapidly and the potential negative impact of panel tests on laboratory budgets.
Respiratory infection testing has been a clear use case for syndromic testing, and the emergence of COVID-19 made a multiplex approach even more critical. Patients and their health care providers simply do not have the luxury of waiting several days to get the answers to a number of single-target tests run in serial fashion, with new samples needed at every turn. But clinical actionability and costs must be carefully balanced.
There is a better approach—one that takes the best of both single-target and panel-based tests: Flex testing.
Flex testing is a relatively recent concept in the clinical diagnostics field. It allows lab teams to run full syndromic panels without having to pay for every result.
Here’s how it works:
Clinical labs implement a syndromic panel with a flex testing option; in this case, we’ll assume that panel is for respiratory infections. Like any syndromic panel, the test will cover the most common viral and bacterial pathogens responsible for respiratory infections, such as SARS-CoV-2, influenza A/B, RSV, and pertussis.
Lab staff prepare the patient’s sample and run the test, generating results for each pathogen. Critically, though, all results are masked, and labs pay only for the results they choose to view. Based on the symptoms and the physician’s hypothesis about the cause of the infection based on symptoms and patient history, a lab tech will unmask the result for the most likely culprit—say, influenza.
If that result is positive, no other results need to be unmasked and the physician can proceed with clinical intervention if needed. If it’s negative, the physician can ask to have more results unmasked until the causative pathogen is determined.
Flex testing allows lab teams to care for a patient’s health and financial well-being at the same time. Answers are generated quickly enough to make a difference in clinical treatment, but costs are managed to carefully to balance clinically necessary testing while minimizing cost to the institution and patient.
This approach also allows labs to expand their test menus, avoid time-consuming sendout tests, cater testing to their specific patient population, and scale to meet seasonal spikes in testing demand.