What to Expect in Molecular Diagnostics for 2018

January 11th, 2018 / Erin McCombs

All signs point to the rise of smart, flexible testing

2018 is still new enough that many of us are reflexively writing the wrong year on paperwork. But it’s just the right time to look ahead and consider what to expect in the molecular diagnostics field. Based on what we see, flexibility and smart testing will play a major role in the coming year.

What to Expect in Molecular Diagnostics for 2018

On the economic front, we believe that reimbursement issues will continue to be the biggest storyline in 2018. The widely anticipated Palmetto guidance, in addition to growing pressure for clinical labs to justify panel testing, will keep this topic in the spotlight. Lab professionals are being asked to make a business case for the use of panels — and while it’s simple to show the positive impact for reducing labor and time in the lab, it’s been more challenging to demonstrate the clinical utility for broad patient populations. It seems likely that targeted tests will remain the first choice for typical patients, while panel tests will be acceptable for cases such as immunocompromised, elderly, and other high-risk patients. In this environment, it will be more important than ever for clinical labs to have flexible solutions, with both targeted and syndromic tests available, as well as flexible testing options to keep costs in check.

Looking at the clinical realm, antibiotic resistance is a major theme that will have a long-term impact in the molecular diagnostics space. There is now consensus that the optimal way to address this public health crisis involves an integrated approach of rapid testing, antimicrobial stewardship programs, and clear actions based on results. Without all three elements, medical teams are unable to make a real difference. Ongoing debate around whether more rapid susceptibility testing should be phenotypic or genotypic has led to the idea that there’s a place for both. Rapid genotypic tests that produce positive results for a resistance marker offer fast, actionable information to improve patient care. Phenotypic tests will remain important for determining susceptibility and when resistance to a particular antimicrobial agent may be caused by multiple mechanisms.

Finally, in operational considerations, we expect that the twin trends of centralization and decentralization will continue to reshape molecular diagnostic testing. Already, some tests are moving from local clinical labs to large reference labs for the economies of scale they can offer. Meanwhile, in many cases, rapid tests have been moving toward the point of impact, so results get to medical teams faster. The major shift here is that instead of running tests where the equipment and expertise dictate, we are now seeing tests deployed where they make the most sense for patient care. Ultimately, this means that physicians will receive results more quickly when it is important, and costs can be reduced for tests that are not as time-sensitive. The trend has largely been driven by the increased availability of automated, easy-to-run diagnostics platforms and rapid molecular assays that are flexible enough to be run as stat or batch tests.

In 2018, we look forward to doing our part to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health.

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