From the frequency of Internet searches to the advent of patient-centered care, it is undeniable that patients are more involved in their own health care than ever before. At the heart of the patient-empowerment movement are tools for information sharing and easy-to-use medical devices, including point-of-care (POC) diagnostic testing.Aside from patient preference, policy experts are looking at POC testing, including at-home sampling and testing strategies, as a means of broadening screening efforts for a variety of diseases while containing costs. As a result, in addition to ensuring test accuracy, laboratories and diagnostics manufacturers are now increasingly considering lay user interfaces in sample collection and test design efforts.Patients Willing and Able
Researchers are exploring rapid, at-home tests for common conditions such as strep throat, sexually transmitted diseases (STDs), and even cancer screenings. Since the 1970s with the commercial availability of at-home pregnancy tests and glucose monitoring kits, patients have demonstrated a willingness to participate in self-testing. These POC tests give immediate results in nontraditional settings and, in addition to encouraging patient responsibility in their own care, they also address patient preferences such as convenience, logistic and travel issues, and privacy concerns. However, over the years, critics have raised many questions about at-home testing. These concerns include questioning the reliability of the tests, particularly with inexperienced users. With the recent commercial release of the OraQuick In-Home HIV test by Orasure (Bethlehem, Pa.), these concerns again came to the forefront in discussions about whether patients were equipped to handle receiving sensitive results on their own and if they would act upon those results. As is the case with the OraQuick HIV test, it has traditionally been incumbent upon the patient to relay at-home results to the appropriate physician and follow up for any needed treatment. While empiric data is still forthcoming from Orasure, traditionally patients do a pretty good job of conducting tests and following up, say experts. Still, there are skeptics. “There is a whole group of people who don’t like at-home testing,” says Catherine Klapperich, Ph.D., director of the Center for Future Technologies in Cancer Care at Boston University. “If we can use fluidics and nanotechnology, we can get more sensitive tests faster and eliminate the barrier of having to send it off to skilled people, [so] why hold the technology hostage?” Experts tell DTET
that the technology to open up at-home testing options for a wider spectrum of diseases is rapidly developing and will begin to be available in commercial markets over the next three to 10 years. In the meantime, POC advocates are still addressing quality concerns. “The problem with POC is that it is less sensitive, but if a patient doesn’t come back to get their results, the sensitivity is zero and then you have to pay to find them and get them treated,” says Charlotte Gaydos, Dr.P.H., professor of infectious diseases at Johns Hopkins University Center for STD Point of Care Tests. “A little less sensitive is OK if you can get them treatment before they leave the clinic. It still saves money and prevents more disease.” Gaydos expects POC tests for STDs to continue to emerge in clinics before they are available for at-home testing, although continued research shows that patients are capable of self-collecting samples. “Patients do a really good job [self-sampling] and the data supports that. Self-vaginal swabs do just as well as [from] a clinician; with good instructions, it is not a concern,” says Klapperich. “With simple devices that are very intuitive it is very difficult to mess up. If people really want to know, if they are motivated, and it is not that expensive—it’s the perfect storm [to drive at-home testing]. . . . It has to be actionable information to empower people to use it at home.” Design will also play a role in driving an increase in at-home testing. “You have to focus on user interface simplicity and reliability because you are putting this technology in untrained hands,” explains Mick Withers, managing director at the global product development advisory firm Sagentia. “Users expect to be treated like consumers, as compared to traditional medical devices that have boring user interfaces. But it is a strong case if you can get medical devices to behave like consumer devices with an intuitive user interface. It is a race to see if consumer products can up the quality to be medical products fast enough.” Models Evolving
A variety of models are emerging to better understand how at-home testing fits into the greater health care system. Some foresee broader access for middle- and upper-income patients who have the education and resources to purchase do-it-yourself tests for themselves at the local pharmacy.
|Mailed FIT Tests Significantly Improve Screening|
|Kaiser Permanente of Northern California sends every member due for colorectal cancer screening an in-home fecal immunochemical test (FIT) kit accompanied by a letter from the individual’s primary care physician explaining the importance of regular screening, as well as directions on how to complete and send in the kit to a central laboratory for processing. Phone, mail, and e-mail reminders are sent to those who fail to return a sample.Between 2004 and 2009 the program nearly doubled screening rates (an increase from 35 percent to 69 percent), allowing Kaiser to almost reach the 90th percentile of performance among commercial health plans and achieve an internal target five years ahead of schedule. Kits are batch mailed by an outside vendor and returned by the patient via mail to a centralized laboratory for analysis.According to Theodore R. Levin, M.D., the gastroenterologist who oversees Kaiser’s colorectal cancer screening program, 3,000 samples arrive daily at the lab. If a test is positive, patients are called back for a colonoscopy. When the project started, Kaiser had 60 gastroenterologists performing 25,000 colonoscopies a year. It now has 105 doctors doing 90,000 colonoscopies annually. After an initial increase in cancers detected, there has been a decline in the number of patients diagnosed with colon cancer, but there is more early detection of cancer. Kaiser’s internal analysis has found that performing annual FIT on members aged 50 years to 75 years represents the least costly approach to screening within U.S. guidelines.|
“A pediatrician colleague buys for all his patients a box of lateral flow strep tests,” says Klapperich. “It becomes ‘run a strep test and call me in the morning’ and then he can prescribe antibiotics. It is a time sink for him to see viral patients. It is an amazing model. Young, middle-class parents will test their own kid for strep—that will be routine.” For others, though, access to these tests is lacking and self-pay drugstore tests remain cost prohibitive. So policymakers are looking toward other models, especially in light of the Affordable Care Act, in which health care providers or payers facilitate at-home testing, ensuring greater integration of testing and results into the continuum of care. In many of these models the patient collects at-home samples and mails samples to laboratories for results. Kaiser Permanente’s colorectal cancer screening program utilizes at-home sampling for mailed fecal immunochemical test kits and provides a large evidence base that a health care system-facilitated screening strategy works to improve population-based screening. All agree that coordination of at-home sampling and testing between patients and health care providers is essential. “You just need to get this connected to the health system to ensure the ability to get treatment,” says Withers. “It requires a great amount of infrastructure for information to flow continuously, but you have to be connected, otherwise there is not much point to doing it.” What Does At-Home Testing Mean for Laboratories?
With technological advances in microfluidics and nanotechnology, development of miniaturized devices is increasingly possible. Wireless communication is already infiltrating home glucose monitoring, ensuring that results are properly reported to health care providers, thereby improving timely communication and disease management. It is a model like this, in which care quality is transformed through cost-effective means, that will drive expansion of at-home testing.
|Allergen Testing for the Home Market|
|This spring the U.S. Food and Drug Administration cleared the MyAllergyTest (ImmuneTech; Foster City, Calif.), the first at-home allergy test. Individuals collect a few blood drops from a finger stick that is mailed to a lab for analysis of 10 common allergens (including food, environmental, inhalants, and animal). The test is available for a list price of $49.95 at chain pharmacy stores, as well as in wellness centers. Results are available within days of sample receipt via a secure Web site or mail.“There are less and less allergists practicing each year. But the number of people with allergies is increasing, so there are lots of parts in the country where allergists are not so available,” explains Lisa Elkins, CEO of ImmuneTech. “Allergies are the number-one self-managed conditions with most medications available over the counter, but allergies are largely addressed by avoidance, so they are conducive to patient testing.”Elkins says the company encourages communicating results with physicians but believes overall “we are definitely moving in the direction of more at-home testing. People want it. Laws are working in its favor, and more and more the FDA is allowing it.”|
“From a policy point of view this is not going away. The Affordable Care Act mandates preventive testing and cost cutting,” says Klapperich. “The only way to do that is POC—in the doctor’s office, at home, or in the minute clinic. . . . We know what powerful forces it could be if a major payer pushes it.” As the Kaiser example shows, at-home sample collection may actually facilitate higher overall testing volumes, as more people who might not otherwise have been screened are brought into health care system. Many scenarios are being pondered as to how the rise of at-home testing will affect laboratories’ work. “There could be a separate stream of business flowing directly from patients. In that scenario the laboratory plays more of a quality control role. Is the sample good? Was it done properly? Did it get here on time?” says Klapperich. “Simultaneously, the demand for personalized medicine will support the clinical lab’s more highly specialized tests. Are we using the right drug combination for optimized therapy? We’ll never do personalized medicine at home. That’s a laboratory function with highly trained staff and highly specialized tests.” Takeaway: As policymakers look for strategies to address the need to enhance quality of care while cutting health care costs, there is growing interest in at-home sampling and testing models. Advances in microfluidics and nanotechnology are nearing a tipping point where broader availability of commercially available of at-home testing products will be feasible. Preliminary research indicates that these at-home testing strategies drive increases in screening volumes for laboratories.