By Jim Poggi
From respiratory pathogens to cancer screening, molecular testing is expanding rapidly. Here’s how healthcare providers and distributors can adapt as more diagnostics move into the physician office.
We know molecular tests have rapidly penetrated the respiratory testing market. Starting with influenza, they quickly provided assays for strep, RSV, CoV-2 and a wide range of less commonly encountered respiratory pathogens.
Availability of these tests at the point of care has been especially valuable as the nation was challenged by the COVID-19 pandemic, but with flu season hitting millions of Americans annually, respiratory testing needs to be continued to be performed where it is most useful, in the physician office.
Every seasoned distribution sales manager I know has multiple customers that rely on molecular tests for flu, strep, COVID and RSV. From a viewpoint of making sure negative results are truly negative, molecular tests have been especially valuable for strep and RSV.
The use of molecular tests is also spreading into other areas in traditional microbiology and displacing tests formerly done on culture plate assays. There are many reasons for this, including:
- Speed
- Accuracy
- Ease of use
- Objective end result
- Reimbursement
- CLIA classification ranges from CLIA high complexity to CLIA moderate and waived.
The changes in the extent of molecular testing and whether they are performed in the physician office or a hospital or private reference lab has impacted some of us more than others. Many of less common infectious disease tests remain CLIA high complexity and are out of the capability of most of our customers’ physician office labs. But, as all infectious disease tests became easier to perform, with friendlier testing platforms, the migration of clinically necessary microbiology tests to the physician office is only a matter of time.
You and your lab manufacturers have helped customers see the need to perform microbiology tests in the physician office. Some, like respiratory tests, are already there, with many of these respiratory tests CLIA waived for easy integration into our customers’ testing practices. Others, like HPV, tuberculosis and STIs have been slower to be adopted, but are moving in the physician office direction, nonetheless.
Testing while the patient is in the office provides assurance that the test will be performed, patient convenience, assures effective counseling whether a result is positive or negative, allows the physician to initiate or modify a patient treatment program and for infectious diseases assures antibiotic stewardship, with antibiotics only prescribed when needed. As cancer testing assays become easier to use, with more friendly CLIA classification, the trend for cancer screening to migrate to the physician office becomes ever more likely.
What does the future look like?
The future is in our hands and those of our trusted lab manufacturers. As distribution account managers, we cannot keep track of all the rapid advances being made by molecular tests displacing traditional microbiology tests. These advances not only include a breathtaking range of new tests but also advances in the testing platforms they are used on. These changes challenge where these tests are performed. Consequently, it is imperative that we keep in close touch with our trusted lab manufacturers as the trend from traditional microbiology tests advances and these tests are replaced by a new generation of molecular tests.
For those of us who have significant revenue associated with current microbiology tests, we need to hold frequent meetings with current customers to understand their approach to adopting new molecular tests and which tests they plan to incorporate into their labs. This is a revenue protection strategy. As microbiology testing shifts to molecular platforms, assuming key manufacturing partners offer these assays through distribution, this is also a revenue growth opportunity.
Beyond microbiology is probably where the trends in market shift due to molecular testing are the greatest and where the new technology is most likely to migrate to the physician office. Screening for cancers is most effective when it is performed closest to the patient. In addition, most cancers can be treated more effectively when diagnosed early.
It is my assumption that not only will sample collection continue to be provided by the physician office (think FOBT and FIT) but the testing for the most common cancers will reside there as well. Advocacy groups including the American Cancer Society and the Unites States Preventive Screening Task Force have created recommendations for which cancers should be screened for and how frequently. Your customers are familiar with these recommendations and you should be as well.
There are some companies communicating directly to consumers and offering tests which can have the sample collected at home and then sent to a private reference laboratory to be performed with results sent back to the patient or their physician. Given the need to streamline the screening process from identifying the need to screen to sample collection to test performance to test reporting, I believe that at home tests will continue to appeal to the “worried well” but that broader screening networks will be offered through physician offices and the core laboratories of associated IDNs. We need to work with and stay in communication with our trusted lab manufacturers as these market trends become clearer and the location of testing becomes more apparent.
It will be up to us and our trusted lab manufacturers to work with our customers whether they are IDNs or individual physician offices to point out the advantages of testing in the physician office.
Are you up to the task? If you want the next generation of cancer diagnostics to be performed by our customers, you had better be. Help work with your trusted lab manufacturers to mold the future to ensure testing is done where it is most effective: in the physician office.
The following link provides the USPSTF screening recommendations: https://www.uspreventiveservicestaskforce.org/uspstf/recommendation-topics/uspstf-a-and-b-recommendations.
Follow this link for ACS recommendations: https://www.cancer.org/cancer/screening/american-cancer-society-guidelines-for-the-early-detection-of-cancer.html)
Where else are molecular tests making valuable contributions to patient care?
Cancer predisposition (whether a patient is more susceptible to a certain cancer than the general population)
Cancer diagnosis, including colorectal cancer, breast cancer and a wide range of others
Cancer treatment follow up using tests that detect very small amounts of circulating cancer cell DNA or other cancer markers
Which traditional microbiology tests have been replaced by molecular tests
- Respiratory, flu, RSV, COVID, multiple less common respiratory pathogens
- Tuberculosis
- Human Papilloma Virus (HPV)
- STIs, including chlamydia, gonorrhea strep B, trichomonas, candida and others
- GI pathogens including salmonella, shigella, and others
- Pathogen culture and sensitivity testing