Avishay Bransky, PhD, CEO and co-founder of PixCell Medical, is an expert in microfluidics, with extensive industrial experience in applied physics, and software and systems engineering. He is one of the inventors of the viscoelastic focusing technique, a cell analysis method, and the microfluidic-based lab-on-a-cartridge. Dr. Bransky holds a BA in physics, BSc in materials engineering, and a PhD in biomedical engineering, all from the Technion Israel Institute of Technology.
The COVID-19 pandemic has highlighted the innate flaws in centralized health care and spurred a momentous shift toward point-of-care (POC) and at-home testing. This trend is expected to continue beyond the COVID-19 era and lead to a renewed interest in POC and at-home testing within the diagnostic industry.
Regulatory constraints, such as those put in place by CLIA (Clinical Laboratory Improvement Amendments), abound in this industry. For example, due to their complexity, most blood tests rated as “moderately complex” by CLIA, like the complete blood count (CBC) test, have been restricted to centralized laboratories. This is due to the risk of attaining erroneous results associated with a lack of standardization outside the quality control processes found in day-to-day laboratory routine. Without following strict lab procedures and lacking the expertise of clinical lab technicians, the results of these diagnostic tests can become compromised.
To provide at-home diagnostic services, these regulations have been overcome by implementing remote oversight of the entire medical operation. Various models have been used, such as complete mobile labs, such as Phlebotomy on Wheels, which collects blood samples and transfers them to private labs for testing; traveling doctors and nurses who simply collect blood samples at home for hospitals; and mobile testing units like Dispatch Health, which provides professional at-home treatment and blood testing for a variety of medical conditions.
"Diagnostic tools must become more robust, portable, easy to use, and reliable."
While these solutions are a step in the right direction for hematology testing, advancement in diagnostic tools remains the most promising avenue for development. Diagnostic tools must become more robust, portable, easy to use, and reliable.
As POC and at-home testing tools, CLIA has started to acknowledge novel technological advancements in blood diagnostics and waive specific instruments for use outside of the lab. Some examples of these waivers include blood gas and hematology analyzers and molecular tests (e.g., influenza tests).
In addition, CLIA now offers individualized quality control plans (IQCP) that help leverage technological advancements in the industry, enabling a transition to greater reliance on instruments with novel internal controls. These systems contain sophisticated built-in mechanisms, sometimes referred to as "electronic controls," that eliminate some of the traditional oversight and the need to run external controls.
One of these built-in mechanisms is imaging-based POC hematology, which uses imaging and artificial intelligence, or AI, to detect different interferences or failures that may compromise results.
As regulatory authorities and lab directors gain more confidence in these technologies and their internal quality control, assays should become more accessible outside the lab setting. This will provide more flexibility for health care providers in treating patients around the globe, from isolated rural areas to the center of bustling cities.
These developments will also reduce costs associated with maintaining highly regulated centralized laboratories and allow lab technicians to focus on the most complex diagnostic cases that require their full expertise.