As the CLIA Laboratory Director at Cedars-Sinai Medical Center, Los Angeles, I can see we are at the beginning of a golden age of medicine. Anticipation about the next generation of diagnostic tests is growing, and clinicians are closely following new developments that could improve patient care and outcomes.
The next generation of clinical laboratory tests include biomarkers for improved diagnosis and tests that give clinicians an early indication of whether a disease may progress or turn into a medically dangerous situation.
One recent example of new diagnostic advancement appears in the journal Clinical Chemistry, where my colleague and I discuss a promising biomarker that predicts the progression of diabetic kidney disease to end-stage kidney disease (1). The findings we discuss appear to be applicable to type 1 and type 2 diabetes and to patients of different backgrounds. Discoveries like this will not only improve patient outcomes, but will also bring us closer to making medicine more efficient and, ideally, more equitable.
How medicine is changing
As science progresses and new diagnostic approaches are proven, well-read physicians and lab directors are eager to implement new tools into clinical practice. Across all our clinical departments at Cedars-Sinai, clinical leaders are acutely aware of the gathering evidence about the utility of new tests. Often, our clinical laboratory is alerted to a new test after a clinician reads about it in a journal or hears from a colleague, but the test may not have yet made it through Food and Drug Administration (FDA) clearance. FDA clearance makes it easier for lab directors to offer a test because it assures us that the test’s analytical performance and clinical validation has been through expert review, and often indicates that the test will soon become the standard of care.
Consider polymerase chain reaction (PCR) technology, which increased in clinical significance and public awareness during the COVID-19 pandemic. Not only did the industry rapidly develop new PCR-based tests – including multiplex tests for flu and respiratory syncytial virus – but there is also accelerated work underway for applications beyond infectious disease. Although PCR and other molecular-testing platforms have been common tools for scientists and researchers for several decades, hospitals and clinical labs are now also adapting and adopting these cutting-edge technologies to support efficient, cost-effective diagnostic testing for all aspects of health and wellness in the future.
Making diagnostics actionable
What clinicians, hospitals, and patients want is testing that informs action. Tests that are immediately actionable can save lives and reduce unnecessary costs. A newly introduced test that assesses a mother’s risk of progression to preeclampsia with severe features is one good example. The test allows clinicians to make critical decisions that affect both the baby’s and the mother’s health, including long-term consequences for the mother, which can include future heart and kidney issues.
In the case of preeclampsia, specialists have urgently lobbied for the development of rapid and reliable tests to predict the risk of disease progression. The challenge? The signs and symptoms of preeclampsia – including blood pressure, proteinuria, maternal symptoms, and basic blood chemistries – were considered nonspecific and highly variable, making them poor predictors of outcome. And that’s why the decision to adopt a first-of-its-kind FDA cleared biomarker test from Thermo Fisher Scientific for the risk assessment and clinical management of preeclampsia was urgently requested by our clinical staff at Cedars-Sinai Medical Center. Now, we have an objective tool to help make critical clinical decisions.
Our clinicians see this test as essential to assess a mother’s risk of progressing to preeclampsia with severe features within two weeks, and 50 percent of mothers who are at high risk of preeclampsia with severe features – based on this test – are ultimately diagnosed with preeclampsia with severe features and their babies have their pre-term babies delivered emergently within seven days of the test result. Just as importantly, we know that mothers who test as being at low risk are almost always able to continue with their pregnancy without needing to have an early delivery. It is this aspect of the test that is especially exciting, because it gives doctors and patients reassurance that they are at low risk, and may prevent a baby from being delivered prematurely, which has serious risks to the newborn’s health and development. Major care decisions, such as whether to immediately transfer a higher risk pregnancy to a tertiary care facility, can now be made quickly, objectively, and much earlier.
Considering how many mothers we care for at Cedars Sinai, and the increasing number of preeclampsia cases nationwide, we did not hesitate to use this test once it received FDA approval. Bringing the new preeclampsia test into the hospital was a collaborative effort between the lab and our heads of obstetrics and family medicine – the ideal model for best medical care at our institution.
Testing and health equity
One additional significant consideration – and benefit – of expanding diagnostic testing is the impact it can have on health equity. Preeclampsia damages the kidneys and can contribute to future development of chronic kidney disease and cardiac risk to the mother; conversely, kidney disease increases a woman’s risk of preeclampsia. Both preeclampsia and chronic kidney disease disproportionately affect African Americans and other people of color who are pregnant. Now, we have an objective tool for assessing disease risk in patients who already have pre-existing risk factors, and this is likely to have a greater impact on the populations at highest risk – a much-needed change.
Health equity isn’t confined to race alone. We improve equity when decisions are made objectively and based on evidence. In this regard, molecular testing and other new diagnostic methods and technologies enable us to use finite resources objectively and more effectively at the point of care. When one mother is not referred to a tertiary care center, for example, because testing showed lower risk, her place could be taken by another mother in greater need, increasing our ability to provide fair, efficient, and equitable use of resources.
When to adopt, and when not to
Some question the wisdom of adding more testing. As a lab director, implementing new tests is our job and we do it all the time – but we don’t do it without justification and deliberate consideration. Our first consideration is always the impact of the test on medical management of patients and the chance of improving their health outcomes. Our second criteria is whether or not the test is FDA cleared, because this provides us with greater confidence in the quality of the test, and because it means my lab won’t have to perform the expensive and time-consuming clinical validation studies required for non-FDA cleared tests under CLIA regulations. Third, we consider turnaround time – which needs to be fast enough to have an impact on medical management decisions. Almost any test can be sent to an outside commercial laboratory, but if the results don’t come back within a time frame that is useful to the doctor and beneficial to the patient, sending out the test can have an unintentionally detrimental effect on care – especially if the care team is waiting for the result to make an important decision. Lastly, we have to consider the cost of the test; every lab director has budgetary pressures and limited resources, but, in the end, the primary consideration is whether the medical impact outweighs the cost.
In the case of the new preeclampsia test, we compared the modest test costs to the significant economic and clinical consequences of a delayed preeclampsia diagnosis or misdiagnosis. The decision was obvious. We created an implementation plan to complete the process in just three months, including validation of tests on our analyzers, adding the new assays to our menu, building the test in our laboratory information system and billing systems and, finally, training laboratory personnel on running the test and providing results. We expect to go live within the next four weeks.
The golden age of medicine will feature increasing numbers of tools that enable more rapid, reliable, and objective diagnostic decisions. We’re already seeing this at Cedars Sinai. Nothing can replace the smart, dedicated, and often overburdened clinicians at the point of care, but, as new tests and testing technologies become available, we can certainly make healthcare more efficient, equitable, and effective for patients.
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References
- A H Bergs, D Sacks, Clin Chem, 69 (673). PMID: 36762398
