The Ascendance of Molecular Point-of-Care Testing

With the Food and Drug Administration’s (FDA) approval last year of four CLIA waivers for nucleic acid-based tests, the field of point-of-care (POC) molecular testing is poised to take off, writes Julie Kirkwood in the June issue of CLN.

Hospitals and clinics are transitioning to more POC testing, and one expert predicted testing companies will rush to bring new products to market.

The leading applications for POC molecular diagnostics are likely to be respiratory infections, particularly influenza, as well as sexually transmitted infections.

Kirkwood found that the faster turnaround time with POC molecular testing pleases both doctors and patients. “Everybody knows faster turnaround time means faster decision-making,” Frederick L. Kiechle, MD, PhD, medical director of clinical pathology at Memorial Healthcare System in Hollywood, Florida, told CLN. “Treatment can be rendered while the patient is sitting there looking at you, instead of going home and coming back for a second visit some other time.” Plus, patients love getting the results back just a few hours after their visit.

POC testing also allows hospitals to stratify patients based on their infectious potential, an important consideration in facilities with shared patient rooms.

As Kirkwood reported, the FDA has given CLIA waivers for POC tests for influenza A and B, strep A, and influenza/RSV. But the potential is tremendous, experts said. In infectious diseases, for instance, such tests could be used for multiplex testing, quantitative assays for viral load, and antimicrobial susceptibility. They also could be used for pharmacogenetics, hereditary genetics, and cancer.

The POC tests are also ideal for use in developing countries to diagnose infectious diseases such as Ebola, dengue, and Zika viruses, as well as HIV and tuberculosis.

“We really can do anything that any PCR instrument can do, so the sky’s the limit,” Dan Kane, lifecycle leader for the cobas Liat System at Roche Molecular Systems, told CLN.

The burgeoning technology brings with it the same management issues as with any POC test, Kirkwood found. As Kiechle stated: “It would be exactly the same. The FDA won’t waive a test unless it’s really easy to do.” Concerns about contamination and mistakes in the pre-analytical phase and interpretation also still exist.

A market report on POC molecular testing predicts the highest uptake in women’s and sexual health clinics, given the cost-competitiveness of the instruments. Lower reimbursement in the respiratory field will limit uptake, the report predicted, given that cheaper rapid tests are already available.

Pick up the June issue of CLN and learn more about the growth and potential of POC molecular testing, including management issues your lab may face.