Point-of-care diagnostics: a boon awaits you with remote health care
From appointments with the general practitioner by telephone to remote patient monitoring technologies: it is difficult not to miss out on telemedicine. Over the past two years, the Covid-19 pandemic has catalyzed a trend that might otherwise have developed much more gradually.
According to McKinsey, the use of telehealth skyrocketed at the start of the pandemic, before leveling off. The “new normal”, however, was a significant departure from what had existed before. The consultancy reported that in February 2021, levels of office and outpatient visits conducted virtually were 38 times higher than before the pandemic.
This change also affects diagnoses, especially when it comes to patients with chronic conditions who need frequent testing. For example, cancer patients may need repeat complete blood count (CBC) tests to see how their condition has progressed and how their body is responding to treatment.
Before the pandemic, this would have involved seeing their doctor. However, since many cancer patients are immunocompromised, this simply has not been possible for most of the past two years. This has sparked demand for home testing solutions, which patients can perform themselves without any risk of catching Covid-19.
“Covid-19 has highlighted the need for decentralized health services as hospital systems have been overstretched to the point of collapse during the pandemic,” says Dr. Avishay Bransky, co-founder and CEO of PixCell Medical. “One of the major delays is in providing diagnostic results to physicians to enable them to make informed clinical decisions quickly. Rapid diagnostics at the POC are changing the way blood tests are managed and performed. »
Wearable platform technology
PixCell Medical has developed precisely such technology. Its HemoScreen device is a miniaturized diagnostic platform for performing the point-of-care CBC test. It allows patients to perform accurate lab diagnoses at home and receive their results within five minutes.
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“The user takes a finger prick blood sample – one drop of blood is enough,” says Bransky. “Blood is drawn in our ‘cartridge lab’ and placed in the HemoScreen analyzer. The technology uses AI and other tools to deliver accurate results in the lab.
While standard hematology analyzers are large and complex, only suitable for use by trained technicians, HemoScreen is lightweight and portable and can be used by anyone. Since its FDA approval in 2018 — and especially since the start of the pandemic — it has been rolled out across the continuum of care.
“It has been used to triage people in emergency rooms, assess the readiness of oncology patients for treatment in infusion centers, in operating rooms to determine if a blood transfusion is needed and in rural settings where access to health care is limited,” says Bransky. “In primary care, HemoScreen can be used in a pediatric setting, reducing anxiety about needles and blood tests for children and parents.”
As this is a technology platform, PixCell Medical is currently developing additional tests that would work on the same analyzer. These include a test for C-creator protein and procalcitonin, markers of infection that would inform clinical decision-making.
An evolution of laboratory diagnosis
HemoScreen is far from the only POC diagnostic device on the market. Medical technology company Athelas is very active in this area, having launched Athelas One in 2017. This device is used to monitor the white blood cell count of patients taking clozapine, an antipsychotic drug. Since its release, the company has launched a full suite of remote patient monitoring devices.
Another technology, currently in the prototype stage, is OmniVerita M, a POC diagnostic platform in development by Biological Dynamics and designed to be used with a normal smartphone. It can be applied in many indications.
“In the field of oncology, we are developing general and high-risk screening tests,” explains Dr. Paul Billings, consultant at Biological Dynamics. “For infectious diseases, rapid testing of potentially exposed people is critical to managing outbreaks and triaging life-threatening cases. There are other areas, such as traumatic brain injury, where being able to rapidly deploy a test can have a profound and long-term positive impact on patients.
He envisions the platform being used in medical offices, or even at home. In low-income countries, the technology could allow humanitarian organizations and local communities to carry out tests if necessary.
“The reason we can imagine our products serving such disparate environments is the ubiquity of smartphones, which we leverage to perform many functions previously only available on lab benchtop instruments,” he says. “Unlike common dipstick-based tests, the integration of smartphone technology enables rapid transmission of test results into a patient’s health record.”
This platform, he says, is more an evolution of existing laboratory diagnostics than a deviation from them. The company will initially run tests using its technology in a lab environment, before migrating to a commercial POC system.
“Many of the components of our tests are similar to those of existing laboratory methods and tests,” he says. “For example, we use dyes found in other labs to stain DNA to determine its abundance in a sample. The difference with our test is that instead of relying on lab equipment, we were able to reduce the form factor to a small device, powered by a cellphone battery.
In addition, the smartphone can replace the laboratory computer; access to the telephone network can replace the networks used by laboratories to send data; and the phone camera can be used to replace a laboratory microscope.
Although Biological Dynamics has yet to begin the regulatory and reimbursement processes for its system, it has received FDA Breakthrough Device designation for one of the tests it is developing. His short-term goal is to create tests that can detect cancer.
Guarantees in place
These types of technologies could hold promise in many branches of healthcare. According to GlobalData, there are currently 65 point-of-care tests in active development, including 15 in infectious diseases and seven in oncology.
However, as the field evolves, questions may arise regarding user error and patient privacy. If patients self-diagnose from home, how can we be sure their findings are accurate? And when it comes to connected objects of this type, how can confidentiality be guaranteed?
In the case of OmniVerita M, the phone’s camera feature is explicitly designed to relieve patient stress. This relieves them of the burden of playing doctor and correctly interpreting the test.
“One of the benefits of using a smartphone is the ability to provide more advanced testing to a broader group of patients,” says Billings. “We can leverage the phone’s camera to ‘photograph’ analytes from a test and then send that image to the cloud where the results can be analyzed objectively. This decentralized diagnostic format is a trend that we are following closely.
He adds that additional test controls will be put in place to confirm that the test was performed according to system specifications. The privacy of patients, meanwhile, will be protected on a case-by-case basis, in accordance with applicable standards.
HemoScreen, on the other hand, uses dozens of internal checks to ensure that erroneous results are not generated. For example, if the user does not collect the sample correctly, the HemoScreen will detect the problem and display an appropriate message.
“The HemoScreen does not store any personal information. Identifying a specific sample can only be done at the hospital’s laboratory information management system,” Bransky adds.
While these types of systems were in development before the pandemic, the events of the past two years have shown us exactly why they are needed. We shouldn’t expect labs to disappear overnight – but at least in some cases, it may not be long before comparable diagnostics are available in our homes.