Nathan Patton speaks to MLO about how molecular diagnostics is used at the point of care to test for certain sexually transmitted infections, including chlamydia, gonorrhea, human papillomavirus, and trichomonas vaginalis.
Q. What trends are you seeing in MDx testing?
A. An emerging area includes patients collecting certain sexually transmitted infection (STI) samples in non-traditional settings. For example, the U.S. Food and Drug Administration (FDA) just approved HPV self-collection, which allows women and people with a cervix to take their own vaginal samples in a healthcare setting that can be used with the cobas HPV test. This type of flexibility opens up options to testing patients who wouldn’t otherwise be tested.
Q. Why is HPV an important focus area for self-collection?
A. This is especially important where certain populations are more vulnerable to cervical cancer than others. This solution could potentially assist in lessening health disparities in cervical cancer, which is more prevalent among Black women and Hispanic-Latina women. Black women are less likely to be diagnosed with cervical cancer, yet they have the highest death rates compared to all other racial and ethnic groups due to profound survival disparities, which may be attributed to a lack of access to timely, high-quality care.1
When patients, healthcare providers and labs have had a chance to become more familiar with HPV self-collection, we see the potential for patients being able to take their samples at home. These trends indicate that molecular diagnostics are advancing quickly, collectively contributing to more effective, efficient, and patient-centered healthcare.
Q. What point-of-care STI tests are available today?
A. To date, there are only two FDA-approved tests to diagnose STIs at the point-of-care, including a chlamydia, gonorrhea and trichomonas vaginalis (CT/NG/TV) assay and CT/NG assay. Both tests have limited indications compared to the epidemic the U.S. is facing, and some turnaround times are not conducive to the POC setting.
Innovation in this space is well underway, and I expect one day there is the potential for molecular point-of-care testing to cover the whole spectrum of STIs, including expansion to genital lesions, mpox, causes of vaginosis or even HIV. These anticipated advancements suggest a future where molecular diagnostics become more integrated into everyday healthcare, driving improved patient outcomes.
For more on the latest MDx trends, see our most recent State of the Industry article by Kara Nadeau: MLO releases findings of 2024 SOI survey on MDx.
- Cohen CM, Wentzensen N, Castle PE, et al. Racial and ethnic disparities in cervical cancer incidence, survival, and mortality by histologic subtype. J Clin Oncol. 2023;10;41(5):1059-1068. doi:10.1200/JCO.22.01424.
