State of the Industry: Disease Management

Respiratory testing trends

When asked how many platforms/analyzers their lab uses for polymerase chain reaction (PCR) testing, 64% of respondents said two-to-three PCR platforms/analyzers, 18% said more than three and 14% said they use only one. 

Tamara Ranalli, Senior Vice President of Molecular Business Unit, QuidelOrtho, commented on PCR trends:

“Laboratory quality molecular testing solutions, especially those using reverse transcriptase-polymerase chain reaction (RT-PCR), continue to move closer to the patient while becoming easier to use and with time to results rivaling those of rapid antigen tests. More syndromic tests are likely to emerge, reflecting the need to test numerous pathogens quickly while reducing technician hands-on time and supporting antibiotic stewardship. In addition, ease of use, even within a laboratory environment, is a desired feature given the reduction in available molecular biologists in labs.”

Regarding reimbursement for PCR tests to detect SARS-CoV-2 and related COVID-19 conditions, 18% of those surveyed said reimbursement is covering their costs, 9% said it was not, and 64% said they were unsure.

“As SARS-CoV-2 volumes decreased, labs have been looking for ways to take their new PCR capacity and use it as an opportunity to offer other tests, such as onboarding tests for sexually transmitted infections or monitoring of viral infections in transplant patients,” said Alesia McKeown, Ph.D., Scientific Partner, Roche Diagnostics. “That shift can help labs avoid sending tests out, saving expenses and decreasing the time to get results in the hands of clinicians and patients.”

The 2022–2023 respiratory season

Lab professionals were asked if they had seen an increase in respiratory testing (COVID-19, flu, RSV) as predicted this year. Most reported an increase, with 14% seeing a significant rise in tests and 55% a moderate uptick. About one-third of respondents (32%) said they experienced no increase in respiratory testing.

Lee Panton, former Lab Director from California who now serves as a consultant, said she has seen an increase in requests for complete panels for respiratory virus screening, but the lab for which she consults does not have molecular testing capability. She described how they handle these test requests:

“In each case, we need to contact the ordering MD and ask for a list of the individual tests that are needed. Then we do the influenza, RSV and COVID tests in house with antigen kits. Other tests are sent to an outside reference lab. This does not allow for prompt diagnosis of all potential respiratory infections. The volume of panel testing is still low. Our corporate office must approve any new testing systems that each of our hospitals are interested in acquiring. Currently, we do not have approval to bring in the new molecular panels.”

Pandemic-driven changes remain in place

The survey found many changes in diagnostic processes for respiratory testing that were implemented in response to the pandemic are now permanent. Topping the list was multiple vendors for consumable testing supplies (59%), followed by more electronic data and less paper (36%), and reallocated or increased physical space for molecular testing (32%).

“As labs continue to struggle with increased post-pandemic testing volumes and decreased staffing, automation is more important than ever to help improve access to testing, accuracy of testing, and speed of testing,” Nikos Pavlidis, VP/GM Diagnostics, BD Life Sciences, commented. “High-throughput, fully integrated preanalytical and analytical systems can enhance both laboratory operations and patient management around STI testing by processing tests at a faster rate and at a higher volume than a lab might previously have experienced." 

Nearly a quarter of survey respondents (23%) said they continue to have less reliance on just-in-time delivery of products and instead have more standing orders in place with suppliers. Increased use of high-throughput platforms and digital pathology remain in place in 18% of labs surveyed, and 5% say they are still using multiple reference labs.

STI testing trends

U.S. medical lab professionals surveyed reported an increase in STI testing, but mostly modest, with 41% reporting a moderate increase in testing in this area, and 5% a significant increase. Over half of survey respondents (55%) reported no increase in STI testing over the past 12 months.

“There has been an increase in the number of reported cases of STIs, which could be due to factors like access to care and the willingness of professionals to talk to patients about the importance of screening when asymptomatic,” said Dr. Damian Alagia III, MD, MS, MBA, FACS, FACOG, Senior Medical Director for Advanced Diagnostics and Women’s Health, Quest Diagnostics. “It seems the more discussion there is about the impact STIs can have on fertility, quality of life, and a person’s health and well-being, the more concerned people are. Yet, STIs are an area of healthcare with significant gaps in care relative to guidelines.”

Patient hesitancy to pursue education on STIs and testing was called out as a challenge by various experts interviewed.

“The focus is less about volume and more about making it easier for people to get tested, reducing stigma to get tested, and providing patients with education on testing,” said Allison McMullen, Scientific Partner, Molecular, Roche Diagnostics.

Pavlidis commented on a 2023 BD commissioned Harris Poll survey that found women feel less knowledgeable about STI testing and treatment options compared to other vaginal diseases and infections:¹ 

“These findings show the importance of providing patients with the knowledge they need to address and prevent STIs. With the CDC reporting that STIs make up five of the top 10 reportable diseases in the U.S.—with increasing incidence—knowledge and education are critical for patients, as is the development of targeted point-of-care diagnostic technologies.”