How emerging molecular technologies help improve the speed & accuracy of diagnosis
Recent advances in molecular diagnostic technology have dramatically altered testing capabilities.
With the healthcare industry turning to value-based payment models that reward organizations for controlling costs and improving outcomes, many providers are asking the same question: What will it take to succeed in this world, where clinical outcomes and efficiency are paramount?
The answer is complicated, of course, but one place to start is improving the speed and accuracy of medical diagnoses. Just as healthcare reimbursements are evolving, so are the tools that providers have to quickly diagnose patients and begin treatment.
Leading the way in this area are molecular technologies like polymerase chain reaction (PCR) tests. These tests identify the genetic material in abnormal cells or the pathogens responsible for disease.
Molecular diagnostics (MDx) has been part of the medical landscape for nearly 30 years, but its adoption by physician practices has accelerated only relatively recently as its capabilities have increased and costs have gone down.1,2 Now, many providers have begun to see MDx as a potentially critical part of their overall strategy for helping their patients get better faster.
With the help of two McKesson Medical-Surgical leaders who consult with physician practices, we take a look at what they believe are the three big trends that explain why this is the case.
Molecular diagnostic technology has become easier to implement for physician practices
Molecular testing works by amplifying DNA or RNA so it's possible to detect and identify bacteria, viruses and other pathogens in a patient's laboratory sample. There are a wide variety of MDx platforms, but most follow roughly the same process to analyze specific sequences in an individual's genetic code for telltale markers of disease.
"Up until a few years ago," says Patrick Bowman, regional sales director with the McKesson Medical-Surgical laboratory equipment specialist team, "the equipment required to run a molecular diagnostic test was so substantial, it would only fit in a very large room." Similarly, those testing platforms were so complicated, "they required that you have a highly complex lab and the personnel and equipment to go with it." That's no longer true today, however, as advances in technology have allowed manufacturers to drastically simplify their systems and processes.
"The equipment has been condensed down so much that now we're seeing analyzer platforms the size of a small toaster," Bowman says. At the same time, though, the equipment works as well as ever, "with a level of sensitivity and specificity that have made molecular testing the gold standard."
That evolution in platform design was the primary reason the Food and Drug Administration (FDA) granted its first Clinical Laboratory Improvement Amendments (CLIA) waiver for a molecular diagnostic test in early 2015.3 Now, says Mary Ferguson, regional sales director at McKesson Medical-Surgical, many MDx tests are CLIA-waived, including certain point-of-care tests for detecting COVID-19.
"This has meant that in many cases, you no longer need a special license and a medical technologist to run and interpret your results," Ferguson says. With that in mind, healthcare facilities of all kinds — from urgent care offices and pediatric practices to family medicine and community health centers — can now offer molecular testing to their patients.
"Now that the barriers to implementation are virtually gone," Ferguson explains, "they're turning to these platforms because they're better than the alternatives. They're faster, more accurate and they're capable of so much more."
Molecular testing has become more versatile & efficient
Improvement in the versatility of molecular testing is what Bowman and Ferguson both believe to be the second major trend behind its growing popularity. Today, they explain, there are many molecular systems that support syndromic point-of-care testing.
"It used to be that you could only test for one thing at a time," Bowman says. That was a significant deterrent to MDx adoption, as providers often thought twice about investing in equipment that might only prove useful in certain situations. "Now that's increasingly rare, and instead, what we have are a number of new platforms with three, four, or even ten or more testing targets."
Bowman explains that you can see the advantage of that among many of the tests used to detect COVID-19. The need for fast and accurate diagnostics to help limit spread of the disease during the pandemic has "hit the accelerator button for molecular testing and syndromic tests in particular," Bowman says. Now, when a patient has a coronavirus test done, they often also have an opportunity to be tested for flu, RSV and other respiratory diseases. "And they can do multiple tests using the same sample and the same cartridge."
The primary benefit of in-office syndromic molecular testing is rooted in its impact on operational efficiency. When a single swab can get results across an array of potentially similar conditions, that not only helps the provider identify effective treatments faster, but it speeds up the overall testing time — and opens up time to see other patients.
Likewise, for patients themselves, syndromic molecular testing can offer a single sample collection and eliminates the need to go back and forth for successive doctor's appointments each time a single test comes up negative. Instead, the patient can get an accurate diagnosis on the spot and immediately move on to the next step in their care, while minimizing the risk of exposure for others. "That's obviously critical for something like COVID, but it can also be important for other conditions, like sexually transmitted diseases," Bowman says.
CLIA-waived STI panels are among the most recent innovations in point-of-care molecular testing, he explains. Bowman also thinks they're just the start when it comes to emerging MDx capabilities.
For patients, molecular diagnostic testing is increasingly preferable
The final big trend influencing MDx adoption has to do with patient preferences, Bowman and Ferguson believe. The more consumers hear about molecular testing and the more they experience it as patients themselves, the more they (and their families and friends) come to expect its availability the next time they need care.
The technology can be a practice differentiator — a chance for providers to stand out from their competition. If one practice only offers antigen tests, which are highly specific but less accurate than molecular diagnostics, it may be at a distinct disadvantage compared to a similar practice that offers both.
A healthcare provider that adopts molecular diagnostics and markets it to their patient population can expect a strong response from those who'd prefer to have access to the accuracy that comes from a molecular diagnostic test. Similarly, organizations that offer mail order MDx testing — in which the patient collects their swab sample and submits it to a reference lab for analysis — tend to receive high marks from consumers who prefer added accuracy along with added convenience.
Bowman observes that molecular diagnostic testing may give patients peace of mind with immediate, conclusive results, just like it does for providers who've decided to make it part of their practice.
For the provider, it's an efficient and highly effective way to support better clinical outcomes — a key to success in current and emerging models of healthcare reimbursement. For the patient, meanwhile, it can be a convincing reason to choose one practice over another.
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Point-of-care molecular testing vs. over-the-counter tests
Point-of-care (POC) molecular testing solutions offer many benefits compared to over-the-counter (OTC) antigen tests. Here are some of the benefits and drawbacks of each.
POC molecular testing solutions
- Requires patient to visit clinician
- Real-time results (in minutes)
- Highly accurate
- Small & portable systems support rapid, efficient decision-making; syndromic testing options available
OTC antigen testing solutions
- Convenient: pick up at your local pharmacy & run the test at home
- Results in about 15 minutes, but not as accurate as MDx
- Accuracy can vary from brand to brand, but generally less sensitive compared to POC testing
- Relatively inexpensive
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1: https://psychesystems.com/wp-content/uploads/2019/07/History_Molecular-Diagnostics_WPv1_2018-11.pdf
2: https://www.mlo-online.com/home/article/13005002/multiplex-molecular-diagnostics-shifting-the-paradigm
3: https://www.legistorm.com/stormfeed/view_rss/452675/organization/31504/title/fda-grants-first-clia-waiver-for-nucleic-acid-based-flu-diagnostic-test.html
4: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013705.pub2/full
Be advised that information contained herein is intended to serve as a useful reference for informational purposes only and is not complete clinical information. This information is intended for use only by competent healthcare professionals exercising judgment in providing care. McKesson cannot be held responsible for the continued currency of or for any errors or omissions in the information.
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