How Beneficial is Digital Pathology for the Laboratory Administrator?
Posted 1st November 2017 by Jane Williams
Whether in a research or clinical lab, digital pathology holds a great deal of promise for all stakeholders. Earlier this year, a digital pathology platform obtained FDA clearance for whole slide imaging, thereby increasing both awareness and applicability of digital pathology. It may, however, be difficult for hospitals and laboratories to justify the acquisition costs of digital pathology platforms if one only looks on the surface. Matt Houliston from Definiens looks at the workflow and economic benefits of adopting digital pathology beyond the perhaps more obvious clinical benefits.
Decrease complexity in the lab
Over the past couple of years, various anti-PD-(L)1 drugs have been approved for more indications, with different indications having different anti-PD-(L)1 options available. This is a trend that is likely to continue based on the number of ongoing trials of new and established anti-PD-(L)1 therapies. With most of these drugs being approved alongside companion and/or complementary diagnostics, pathologists need to be able to align the drug, test, indication, line of therapy, and biomarker positivity thresholds in addition to being able to reliably read the slide.
This is no easy task, and digital pathology aided by image analysis can conceivably support the creation of a platform that can:
- Allow a pathologist to input the indication and line of therapy
- Obtain software that identifies the correct reagents to use
- Establish what the biomarker positivity threshold is (or what a harmonized cut-off might be)
- Quantitatively score the slide
This will decrease individual error rates and time spent ensuring the right reagents and cut-offs are used relative to manual methods.
Increase Laboratory Revenues
One task of hospital and laboratory administrators is to ensure revenues for services rendered and to grow those revenues when possible. In the United States, reimbursement codes exist for computer-assisted immunohistochemistry (IHC) that pay out higher rates than codes for manual methods. According to the 2017 Medicare Physician Fee Schedule, the computer-assisted code pays 29% more than the manual code. By adopting digital pathology, labs could bring in more revenue per case, and when amortizing the cost of the acquisition of technology over the thousands of cases, the margin of IHC services should improve.
Additionally, there has been some interesting data that has been presented in the last year or so that indicate that predictive IHC-based signatures may be developed by pharma and their CDx partners for new and established immunotherapies (e.g., Althammer S, et al., 2016). These signatures rely upon quantitating the number of multiple biomarkers simultaneously, observing the morphology of immune and tumour cells, and measuring the spatial relationships between the cells. This is beyond what even the best and experienced pathologists could accurately measure, and adopting a digital pathology platform enables a laboratory to collect on the associated reimbursement that would otherwise go to an outside reference lab.
Integration of Digitised Data into EHRs for RWD
Hospitals and other places of care are treasure troves of valuable real-world data (RWD) that can be utilised by academic and pharmaceutical researchers. Care providers should have a history and physical on all patients, pathology reports including IHC and genomic data, the drugs the patient has tried, and patient outcomes following use of those drugs (including adverse events). Among other relevant data, this is all integrated into electronic health records (EHRs).
Through the adoption of digital pathology and image analysis, images and quantitative data can be seamlessly integrated into EHRs. Researchers can use this to mine valuable data to inform diagnostics and treatment strategies, look at drug development options, and clinical trial designs. This is an opportunity for hospitals and laboratories to increase revenues by selling this data to pharma or increase the number and amount of research grants to fund internal studies and create valuable intellectual property.
While the increase in the number of effective cancer treatments is a clear win for patients, the ability of physicians to decide which treatment is the best option for each patient has become difficult as a result of many choices. This is as hard or possibly harder for pathologists as the number of associated companion and complementary diagnostics increase. By increasing the size of the test catalogue at a hospital laboratory, not only does this increase patient accessibility, but it has economic benefits for the laboratory as well.
By adopting digital pathology and image analysis, the laboratory may improve the financial standing of the laboratory and hospital while putting them in a position to better help patients today and in the future.
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