IVDT_In Vitro Diagnostics Technology

IVD Technology, November/December 2012

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PATIENT-DATA MANAGEMENT Patient Self-Testing (PST) Cost Distribution Typical Test Frequency Reimbursement $100−$1000 devices Equipment sometimes leased with $2−$20 consumables Millions of patients Multiple days per week to continuous Time to Result Seconds to minutes Sometimes available to patient, often via FSA; sometimes reimbursement to physician for training patient Example IVD Tests Blood glucose INR/PT Albumin Ketone Data Collection Regulatory Patient collection; often proprietary software for trend analysis; rarely connects to physician office in practice 510(k), CLIA-waived Table I. Models for patient-centric diagnostics. normalized ratio (PT/INR). Th ese tests and their results have moved to where they can perform a service. When Sir Th omas Albutt invented the clinical thermometer in 1866, he did not imagine that every house- hold would consider it an essential medicine cabinet accessory and com- mon diagnostic tool that would be used by patients themselves. Today, from pregnancy to cholesterol tests, consumers are not only able to pur- chase dozens of diagnostic tests at their pharmacies, they can also pay for them from their employer-off ered fl exible spending accounts. Sales from 2009 to 2011 have increased 35% in this segment.1 Th e most noticeable shift, however, has happened outside the pharmacy. Apple online sells glucose monitors from Sanofi and blood pressure cuff s from Withings. AT&T stores sell a device that tracks your physical activ- Consumerization of Diagnostics ity and sleep while Nike puts health sensors in shoes. Th is consumerization of medicine is not just a health phenomenon among the "worried well," but also an important component in chronic- disease or intensive therapeutic man- agement. Self-management of blood glucose (SMBG) is a standard of care because it may lead to improved glycemic control, and consequently a reduction of HbA1C.2 when Medicare approved home PT/ INR use, new consumer-friendly models of PT/INR meters were designed to transmit data wirelessly to computers and, ultimately, physi- cians, who could optimize therapy. In several studies, the number of complications under this regimen declined.3 After 2009, clinical in appearance and not user friendly. Newer devices are "smart" and have designs that take their cues from Apple and Herman Miller; some examples include Alere INRatio2, Zio Patch, Bayer Contour, Tandem TD, Animas Ping, and Ferraris Piko. Big Data for Big Decisions Why would patients want access to digital diagnostic devices at home? Patients cannot diagnose themselves, cannot prescribe themselves medica- tion, and often cannot control the course of their diseases. What they can do is regain a feeling of control by having the data. Reimbursable home diag- nostics include pulse oximetry, peak fl ow meters, blood pressure cuff s, glucose meters, ketone urinalysis, microalbumin, as well as pregnancy and ovulation tests. Th e original designs of these devices and tests were 26 IVD TECHNOLOGY | NOVEMBER/DECEMBER 2012 Nicholas Genes, MD, PhD, an emergency physician in New York and editor of the online medical blog MedGadget, has noted a rise in patients showing up in the emer- gency department with self-reported elevated blood pressure readings. He notes that unlike a patient who has received diabetes education and can understand trends, these consum- ivdtechnology.com Physician Office Lab (POL) $1,000−$10,000 devices $2−$20 consumables 200,000 points of care (physician's office, emergency care, pharmacies, etc.) 3 months to annually Seconds to hours Sometimes reimbursement for offering the test, blood draw, etc. HbA1c CD4 INR/PT Chemistry WBC Test-by-test results; sometimes available to EMR; rarely offers trend analysis 510(k), CLIA certification Patient-Collected Samples (PCS) $500,000−$1,000,000 device $5−$10 consumables, shipping and handling 2–3 high-complexity hubs Biweekly to monthly Days Reimbursement being studied TSH HbA1c Cancer markers Lipids and cardio-metabolic health IGEs ALT, AST Therapeutic drug adherence Test-by-test results, reported to physicians and patient; sometimes connects to EMR; sometimes offers trend analysis Lab developed test (LDT)

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