Your career began with a focus on hematopathology and you’ve grown to assume broader roles in the industry. Was there something that drew you to this area of specialization within the lab diagnostics industry?
I also chose it because it afforded the opportunity to be part of the most innovative area in lab medicine. Hematopathologists have been at the forefront of most advances in medicine – the first cancer linked to a chromosomal defect was a leukemia (CML), and the first cancer treated by a drug targeting a chromosomal defect was also a leukemia.
More recently, the first cancer type characterized by gene expression profiles - allowing for better prognostic information and better tailored chemotherapy – was a hematological cancer, diffuse large B-cell lymphoma.
You’ve described your role at Ortho Clinical Diagnostics as ensuring assays “are best positioned to meet unmet clinical needs, improve patient outcomes and lower overall healthcare costs, through better and faster diagnostics.” What are some of the ways you accomplish this?
Primarily, I maintain close communication with clinicians and other KOLs for careful understanding of patient-care pathways. Together, we define the roles a lab test plays in these pathways, and carefully review the published literature to confirm the true value of each test.
Finally, we assess the real impact to patient care, which is evidenced through actionable test results. For example: in the sepsis space, there were nearly 200 proposed biomarkers in the last decade. The majority of those provided information on patient prognosis, but the major opportunity to improve patient outcomes was in early diagnosis/early treatment. There was a disconnect between what was being published and where the main clinical needs were.
Within Ortho’s product family, patient safety and avoiding lab errors are top priorities. Has lab automation had any influence on how you achieve these goals?
Automation is clearly an operational improvement, but it also critically impacts patient safety. Ortho`s analyzers, both in chemistry and immunoassay, have unique-in-industry safety features which significantly lower the risk of interferences and erroneous results.
This happens in many ways. Our XT MicroSlides have a filtering layer which removes interfering proteins. Our chemistry analyzers do not use water and are not impacted by the water quality problems prevalent in many labs. Automated detection for hemolysis, icterus and lipids removes impact on testing workflow and works at low sample volume. We have automated detection of sample integrity issues such as bubbles and clots and disposable aspiration tips, which eliminate analyte carryover.
All of these are critical, unique safety features of Ortho`s analyzers. In this context, the addition of automation to our offering enables more labs and more patients to benefit from these unique technologies critical to patient safety. Recently, for example, we announced the completion of Ortho’s VITROS XT Solutions, a comprehensive suite of lab solutions that brings all of these unique safety features to an integrated platform with greater throughput for the lab directors, physicians and patients relying on quick and accurate results.
Along with sepsis, what are the top diseases and/or challenges facing the clinical lab industry, and what is the forecast for addressing these issues in the future?
The main challenges and opportunities for clinical labs today lie with acute and critical-care diseases, such as acute coronary syndrome, acute heart failure and acute kidney injury. With these conditions, speed is the critical factor impacting costs and outcomes.
Yet, patient history is often weak or absent, the consequences of erroneous results are most serious, and typical measures to mitigate technology limitations are not possible (i.e. sending out tests to mitigate menu gaps). These factors are among the main drivers of increasing healthcare costs worldwide; as such, they should be of primary concern to all stakeholders. Labs need to make the quality of care they provide to their acute- and critical-care patients a main priority.
As such, there are several new advances becoming available to labs, which enable them to meet the needs of these patients. Novel assays allow for identification of patients at greater risk of acute kidney injury. Recently developed high-sensitivity troponin assays - with precision performance superior to IFCC requirements - allow for new clinical uses of HS troponin through the detection of minimal myocardial necrosis, even in patients not having an AMI.
For these acute and critical patients, accurate test results that are free of interferences are of paramount importance, and labs need to consider patient safety their primary driver when assessing their possible business partners. While in medicine we take pride in innovation, one core value has not changed in over 2,000 years, “First, do no harm.”
