IVDT_In Vitro Diagnostics Technology

IVD Technology, November/December 2012

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PATIENT-DATA MANAGEMENT Ten Economic Motivators for Patient-Centric Diagnostics BRYCE SADY AND MANFRED SCHOLZ Diagnostics is undergoing a trans- formation from identifying specifi c values at specifi c points in time for a specifi c sample (a product) to gen- erating data and decision analysis for patients and their physicians (a service). We are now seeing three complementary models for more sophisticated acquisition and manage- ment of patient data: mail-in tests on patient-collected samples (PCS), phy- sician-offi ce laboratory (POL) tests nexus of symptoms and a large dif- ferential diagnosis, her doctor put an iPad in her hands. For years, she was accustomed to going months between tests and receiving single, typewrit- ten, numeric results. Th is system was replaced by high-frequency diagnos- tics combined with data that she was acquiring and managing herself. Since her last visit, Jennifer had been mail- ing dried capillary blood spots to a lab on a regular basis to establish a trend of TSH levels. She had also been recording daily temperature, weight, and levothyroxine doses with her smartphone. For the fi rst time in her medically complex life, Jennifer felt she was invited to share in the clinical decision-making process. W hen Jennifer went to her endocrinolo- gist after almost three years of living with a mysterious ivdtechnology.com on small systems, and the consumer- ization of diagnostics through patient self-testing (PST). Th ese models will make Jennifer's experience a reality for more people. Patient-Collected Samples One development is to have patients send samples through the mail or in person to high-complexity labs. Patient-collected samples can be generated with high frequency, and results can be used to determine baselines and trends for multiple ana- lytes. One company, Siscapa Assay Technologies (Rockville, MD), is developing a proprietary method to accept capillary blood spots from fi nger-pricks on treated fi lter paper that contains a bar code with a patient identifi er. Th e patient sends these samples to a central lab, where high- rate mass spectrometry can be used to determine results for up to 50 pro- teins. Th is new delivery model off ers several advantages: • Patients are more likely to complete these tests, baselines can be estab- lished, and intra-exam trending values can provide better diagnosis • Capital costs are concentrated on very few facilities. than a one-time measurement. • Sample collection is cost-eff ective because the patient can perform it without an offi ce visit. Small Systems Another trend is toward low- throughput, small, inexpensive sys- tems that can be distributed where they are needed. In the 1990s, tro- ponin tests made it into the emer- gency department on the backs of small instruments such as Roche's Cardiac Reader. Th ese systems require no sample preparation or calibration, performing just one urgent assay on a microliter sample size. Generally, they can send results right into the electronic medical record, although such electronic connectivity is not yet ubiquitous. Roche, Alere Biosite, and Hemocue (Quest) have pioneered this model with designs suitable for a coat pocket or for the closet-sized "lab" or exam room at many practices. Th ey off er ambulatory platforms for infec- tious disease tests, and tests for hemo- globin, cholesterol, albumin, HbA1C, and prothrombin time/international IVD TECHNOLOGY | NOVEMBER/DECEMBER 2012 25 IMAGE BY ARAKONYUNUS/ISTOCKPHOTO.COM

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