The Solution We Need!
The novel coronavirus that inflicted humanity in late 2019 has taught us that to effectively break transmission chains and slow the spread of any highly infectious pathogenic outbreak, testing is needed at homes, at offices, and schools and that results are needed quickly and on the spot. While fulfilling all essential prerequisites for a scalable and robust solution is a challenging task, various technologies, including Proactive Diagnostics’ own Q-SENS platform, are ready to meet this urgent task and bridge this problematic gap.
Since the break of the COVID-19 pandemic, countless news items have appeared, reporting on imminent testing solutions that could provide relief in these troubled times. But as of the time of writing, 10-months after the first signs of the pandemic were reported, other than the initial and common polymerase chain reaction (PCR) test, which delivers results in many hours or days and fails to meet desired levels of sensitivity and specificity, no new solution has been widely adopted yet, neither globally nor by any particular country.
The reason — While the media is keen to bring hopeful news that drives up the ratings, and while developers seek any bit of exposure to bring their proposed solutions to light, significant gaps in meeting the requirements of a true testing solution to the pandemic, still exist!
As humanity continues to await breaking news of a validated and FDA approved vaccine or effective medication — two endeavors not without their challenges — it would be wise to experiment with new diagnostics technologies and solutions, which could aid in combating the current pandemic, and not least so, prepare for future pathogenic outbreaks that many deem inevitable.
Forget about lab-testing, forget about point-of-care diagnostics.
The term “point-of-care diagnostics” has been the holy grail and, to date, an unattainable goal in the world of molecular and immunoassay diagnostics. Many of the leading companies in the field of medical devices, in light of the recent crisis, have been striving to fill this newly-highlighted gap of achieving point-of-care capabilities. But surely, even this yet to be realized goal has its limitations. Testing patients at the points-of-care on an occasional mandatory basis, even if the reach expands to local pharmacies and other local testing stations, always runs the risk of turning a false-negative when testing patients in the early incubation stages of infection. In light of this, it may be appropriate to move from talking about point-of-care, towards a new term — point-of-need diagnostics, already employed by some.
What the current pandemic has taught us is that testing is needed at homes, at offices, and schools and that test results are needed here and now. Indeed, quick and frequent testing of individuals at various points throughout their daily routine would provide greatly improved means of interrogation. However, multiple models suggest that the only way to keep infection rate down while allowing for re-opening of the economy and schools is by having a daily-home-test that can detect infected individuals as close as possible to the time of contracting the virus, and enable the immediate breaking of transmission chains. This is true for the current SARS-CoV-2 virus and will remain so for all future highly infectious viruses, some of which may prove much more lethal.
What would the ideal solution for curbing pathogenic outbreak, such as COVID-19, look like?
Fulfilling all essential prerequisites for a robust point-of-need solution is no easy task: First, the selected platform must demonstrate performance equal to or better than central lab tests. This means generating high levels of sensitivity to eliminate false negatives and high level of specificity to eliminate false-positives; Second, the time from testing to results must be short enough to enable mass testing and provide people with results within minutes, rather than days or hours, so that they can self-quarantine immediately if needed; Third, the sample used for the test, be it blood, saliva, or any other bodily fluid, must be simple to collect and small enough to allow it to be obtained in a minimally-invasive manner, and without the need for a phlebotomist; and fourth, pricing, both of the analyzing device and the consumables used per test run, must be affordable, to allow wide deployment and repeated testing on a multi-national or global scale. This naturally correlates with the device’s size and portability, which should ultimately be available as a hand-sized instrument that can be conveniently kept in one’s home. And finally, the test-result must be uploaded to the cloud, either through a patient’s phone-analyzer or through the reader of the device itself, to enable big-data collection, integration, analysis, and reporting through use of machine learning and artificial intelligence. The sort of insight that will be drawn from such connectivity takes the value of effective point-of-need testing to a whole new level, enabling informed decision-making on smart lock-downs and targeted quarantines and the crossing of the data collected with clinical outcomes and personal medical history to elicit a more nuanced understanding of patients’ susceptibility to infection.
Home-testing solutions and Proactive Diagnostics’ innovation
The notion of home testing is a broad one that greatly varies between different detection technologies and targeted markers when attempting to diagnose different physical conditions. Some urine, enzyme-based, home testing kits, for instance, combined with phone analyzers, are already available, but the data that can be derived from such tests is limited. Proactive Diagnostics’ vision of enabling immunoassay and molecular assay testing at home, allowing multiplexing up to 32 tests, targeting multiple proteins, nucleic acids, and/or small molecules, simultaneously, is a more ambitious development. Its potential applications and the information that could be derived from it is truly vast and goes far beyond curbing pandemic outbreaks.
We are committed to developing our Q-SENS platform to a product and collaborating with strategic partners to accelerate bringing to market as many tests as possible. Such a solution, once available, will completely change the existing testing paradigm and empower individuals, with guidance from their physicians, to take control of their wellbeing, in a personalized manner, like never before. But for the sake of coherence, let us stay on point — what could home immunoassay and molecular assay testing, do to address a pathogenic outbreak like the one we are currently experiencing and to have helped us avoid a great burden to the global economy and save the lives of so many, worldwide.
We will discuss this question in our next blog post.
Click here to read about how the current COVID-19 pandemic has crystallized the need for point-of-care diagnostics.
Click here to read about how groundbreaking point-of-need technologies could aid in curbing future pathogenic outbreaks.
Click here to learn about our proposed COVID-19 solutions.
