I have been closely tracking the development of new at-home lab testing devices because I think, accompanied by expanded telemedicine choices, the face of healthcare will be changed forever. A recent article in Dark Daily announced such a device for complete blood counts (CBC) (see: New At-Home CBC Device Enables Complete Blood Testing for Cancer Treatments and Biological/Viral Monitoring). Below is an excerpt from it:
.....[N]ew devices that enable chronic disease patients to monitor and report findings to care providers continue to be developed and embraced by healthcare consumers. 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....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....According to Athelas, in about 60 seconds the blood analyzer provides accurate reading for: Neutrophils; Lymphocytes; Platelets; White blood cells; Morphology; and, Cell activation.....The home-testing platform will cost consumers $20 per month, which Athelas hopes will eventually be covered by insurance companies....
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 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.
So, as a quick review, we now have devices for home CBC testing as noted above, home hemoglobin testing with the Germaine AimStrip as one example, and home coagulation testing with the Roche CoaguChek as one example. This latter device is relatively expensive at $555.55 but all of these devices are CLIA-waived and thus could also be deployed in walk-in clinics such as CVS's MinuteClinics. Coagulation status monitoring is complex but could reasonably be performed with the oversight of a well-trained pharmacist. I blogged about a similar coagulation monitoring program at Geisinger 12 years ago (see: Pharmacist-Staffed Coagulation Clinics in a Large Health System).
Here's a few observations I have made about the Athelas CBC device described above:
- After a finger prick, a drop of blood is placed on a proprietary testing strip which is then placed in the testing device. Like other home testing devices, information can be sent to a smart phone and subsequently transmitted to a healthcare professional. This is similar to the strategy used for other home testing devices for which smart phones serve a key function (see: AliveCore).
- Athelas has chosen a monthly rental of their pricing strategy. This makes sense for the first entry into the market of such a device where the purchase price may be prohibitively high. Renting allows devices to be reused. Moreover and because the initial use is targeted for cancer patients, demand will be limited to the period when the patient is being intensively treated.
- Also of interest is that the Athelas web site emphasizes that the company is working hand-in-hand with the FDA ("Working with the FDA from Day One") and also boasts about the fact that its device is clinically validated (Read our third-party clinical white paper on the accuracy of our capillary WBC and Neutrophil results versus venous blood samples on the Sysmex 500")
- As I have stated previously, at-home testing coupled with telemedicine visits will inexorably whittle away at the volume of on-site ambulatory care visits in the U.S. In time, this new approach to care will also reduce the test volume of hospital-based clinical laboratories (see: Telemedicine and Home Monitoring Will Promote Healthcare Transformation).