Chronic disease monitoring at home has become a boon to patients as well as hospitals that are finding cost savings in programs designed to monitor/treat patients at external locations
Many clinical pathologists and medical laboratory scientists will be wary about the news that a California company wants to have cancer patients do their own CBCs at home, and that a device to enable such testing is being prepped to go through the FDA clearance process.
Home-based medicine care and chronic disease therapy treatments are gaining in popularity. Patients, understandably, would prefer to stay in the comfort of their homes then be exposed to stressful, germ-laden healthcare environments. And healthcare providers are finding cost savings in home-healthcare programs, which Dark Daily recently reported.
However, each new breakthrough in home medical care impacts clinical laboratories when specimen collection, near-patient medical laboratory testing, and therapy administration/monitoring shifts from traditional healthcare environments to home settings.
Nevertheless, new devices that enable chronic disease patients to monitor and report findings to care providers continue to be developed and embraced by healthcare consumers.
Complete Blood Count at Home
One such device from Athelas, a diagnostic test developer based in Mountain View, Calif., makes it easier and less expensive for patients undergoing cancer therapy to monitor their complete blood counts (CBC) at home without the need to travel to a doctor or medical laboratory to have the blood work performed, Medgadget reported. The device, which is undergoing the FDA Class 2 clearance process, enables patients to test their complete blood count (CBC) in the privacy of their own homes and report the results to their oncologists.
To use the Athelas device, patients perform a simple finger prick and place a drop of blood on a proprietary testing strip. The strip is then inserted into the device where the blood is analyzed. Patients can view their lab-grade blood test results in about a minute.
Information gathered by the device can be sent to Android or iOS devices/apps and also to the patient’s doctor. The process allows patients and their doctors to receive frequent updates for monitoring treatments and disease progression and precisely observe changes in immune health.
According to Athelas, in about 60 seconds the blood analyzer provides accurate reading for:
“Athelas is bringing cancer patients a quick and reliable way to test their blood levels from within their home,” noted Alfred Lin, partner at Sequoia, in a statement. “Their new platform empowers patients to confidently monitor their condition and will cut down on unnecessary urgent care visits. We believe in Tanay and Deepika’s bold vision to transform at-home blood tests into an easy and accurate diagnostics tool that’s as trusted as a thermometer.”
The home-testing platform will cost consumers $20 per month, which Athelas hopes will eventually be covered by insurance companies.
Additional Benefits to At-Home Monitoring
The Athelas device also has functions beyond chronic disease monitoring. It can be used to determine if a viral or bacterial infection is present in an individual. In addition, the company is currently testing the machine with 100 patients at risk for a cardiac event to evaluate whether or not it can predict such an event days before it occurs.
“There’s a lot of research out there that shows inflammatory markers inside your own body will spike a couple days in advance,” Tandon told TechCrunch.
The Athelas device is not yet cleared to market by the Food and Drug Administration (FDA) and more clinical research may be needed to validate the efficacy of the product. Athelas is currently loaning the device to cancer patients for the purpose of monitoring their chemotherapy progress, and is conversing with healthcare professionals, hospitals, and pharmaceutical companies regarding the benefits of the device.
Other CBC Devices
In 2017, Sysmex America announced it had received clearance from the FDA for the Sysmex XW-100 hematology analyzer, the first CBC system that allows in-house staff to perform CBC tests at Clinical Laboratory Improvement Amendments (CLIA)-waived locations. The Dark Report reported on this last year. (See TDR, “FDA Clears Waived CBC For Near-Patient Testing,” November 20, 2017.”
The XW-100 device enables physicians to perform in-office blood tests and receive results in as little as three minutes. This allows treatment plans to be initiated without interacting with clinical laboratories, which clearly impacts test ordering and lab revenue.
At-home and onsite blood testing devices serve an important role in patient care and provide healthcare professionals with expeditious and convenient test results. However, with the arrival of these new technologies, clinical laboratories will need to find new ways to bring value to physicians who employ them in their offices.