For immunocompromised patients, such as those with cancer or organ transplants, the novel coronavirus crisis has made going to hospital for regular blood tests an even greater health risk.
Home-based or remote-based testing kits for Complete Blood Count (CBC) — the most common blood test used to check overall health — could eliminate this danger.
And that’s exactly what PixCell Medical, an Israeli innovator of rapid point-of-care (POC) diagnostic systems, hopes to achieve.
“Patients receiving oncology therapies are immunocompromised and susceptible to infection,” says Dr. Avishay Bransky, CEO of PixCell Medical. “A hospital environment presents a major risk, due to potential contact with other patients, staff and for hospital-acquired infection. As such, we believe that enabling the shift to home care settings for oncology, in particular, is a crucial evolution in cancer care.”
The debate for chemotherapy treatment at home has been on health agendas for years. Now, the COVID-19 pandemic is prompting healthcare organizations the world over to scale up digital health adoption and focus on new medical device solutions.
PixCell has collaborated with health funds, hospitals and health studies in Israel, Australia, the US, Denmark, and Sweden.
This month, PixCell announced a collaboration with Interreg Germany-Denmark’s Changing Cancer Care (CCC) initiative to assess the ability of PixCell’s HemoScreen hematology analyzer to enable home-based testing of blood values to support oncology treatment of cancer patients in homecare settings.
Through the study, patients will be trained to use the HemoScreen system to perform the five-part CBC test required to manage patients’ oncology therapy treatments and support clinical decision making.
“Nowadays, there are chemo treatments that can be taken at home. The problem is that you must have a full CBC to determine if the patient can get the chemotherapy treatment or not,” Bransky tells NoCamels. “Once they can do this blood test at home, the physician can remotely monitor the treatment, and this will make [at-home cancer treatment] feasible. Giving patients the ability to use HemoScreen for CBC at home could be the next revolutionary evolution enabling at-home oncology treatment.”
The FDA-cleared and CE-marked PixCell platform shortens diagnostic results delivery from days to within six minutes.
“We needed a simple, intuitive and portable device that was easy to operate, and could provide both rapid and accurate results,” Ditte Luise Hartvig, project manager at the Department of Research Projects and Clinical Optimization at Zealand University Hospital, said in a statement. “HemoScreen fulfilled these criteria and offered the sophisticated CBC analysis required to meet the monitoring needs of clinicians, and also met the ease-of-use and portability criteria for our patients to participate in this study from their homes.”
The goal of this study, led by the Department for Research Projects and Clinical Optimization at Zealand University Hospital, is to enable patients to test their blood levels safely and routinely at home.
“Draw blood, insert the cartridge into the device and get a result,” Bransky says, in summing up the rapid and simple blood sampling and analysis PixCell offers.
The company’s analyzer uses disposable cartridges for its CBC blood count of 20 standard parameters, including RBC count, RBC indices, absolute WBC count, WBC 5-diff, and hemoglobin and platelets.
Of course, PixCell is not the only lab-grade blood testing solution on the market. Israeli-founded company Sight Diagnostics received initial FDA clearance in December for its OLO analyzer, a device that performs blood tests including CBC.
But PixCell says there are important differences.
“We’re the first and only FDA-cleared full CBC, which is intended for use in point-of-care. We have 10 years of research and development, and over two dozen patents,” Bransky tells NoCamels. “Our competitors use imaging, as we do, but they use a chip and not a cartridge. We have a ‘lab on a cartridge’ and this is where our innovation lies. The standard practice is flow cytometry. We combine flow and imaging cytometry. The cartridge automatically prepares a sample. It simplifies blood testing.”
The patent-protected device uses an underlying technology known as viscoelastic focusing (VEF), which was first discovered at the Technion–Israel Institute of Technology. VEF causes cells to perfectly align into a single cell layer while flowing, thus accelerating their analysis.
HemoScreen’s disposable cartridge includes all necessary reagents and requires no maintenance or calibration. This eliminates cross-contamination risks and accelerates automatic sample preparation including labeling, staining, and incubation.
“Our device is very accessible, and anyone can run a test. You need no expertise,” adds Branksy. “This makes it accessible in remote areas or at home.”
For oncology patients worldwide, this device could save time and keep other infection risks to a minimum.
“Currently, ill patients must travel to clinical centers for blood tests, not knowing if they are ready for treatment, spending hours waiting for their CBC result, only to be told that they aren’t ready yet,” Dr. Niels Henrik Holländer, Leader of Changing Cancer Care, Department of Clinical Oncology at Zealand University Hospital in Næstved, said in a statement. “With HemoScreen, we can potentially save patients significant time and energy exertion when undergoing these serious treatments, and also save time and costs for hospitals.”
“Governments are aware of the need”
Indeed, it is not just cancer patients or the immunosuppressed who could benefit from this portable blood diagnostics system.
The portable POC device performs highly complex tests, currently confined to high-end labs. CBC is used to detect disorders including infection, anemia and leukemia. Making CBC tests accessible at the point-of-care can enable early detection of health issues and thus save lives.
Earlier this month, PixCell, located in a hilly region of the lower Galilee at the base of the Carmel Mountains, sent its kits to Australia. Bransky tells NoCamels that the “small health clinics in remote areas are ill-equipped” and some residents Down Under need to drive four hours just to get a blood test.
“Governments are aware of the need and lack in devices,” he says. “They can screen earlier for cancer but also for other health issues — be it a car accident or anemia or even allergies. All of these decisions are made based on CBC. If we can make a common test more accessible, people everywhere can get better healthcare service.”
This article first appeared in NoCamels, which covers innovations from Israel for a global audience.