The Theranos fiasco (see: The rise and fall of Theranos, the blood-testing startup that went from Silicon Valley darling to facing fraud charges) served to cast a pall over the micro-sample diagnostics market. Now comes news about an Israeli company with a similar strategy but this time with an instrument providing a complete blood count (CBC) and a green light from the FDA (see: Unlike Theranos, startup’s blood test device ‘delivers on promise’ with FDA nod). Below is an excerpt from the article:
Israeli startup Sight Diagnostics has received US Food and Drug Administration clearance to market a blood test device that can extract the results of a standard complete blood count test from just a drop of blood in minutes....Sight’s OLO is a new type of blood analyzer that promises the same accuracy as large laboratory machines but is cost effective and can be used at the point of care, giving physicians the results “in minutes” ....To use Sight’s product, the physician or nurse pricks the patient’s finger and places a drop of blood into a disposable plastic cartridge that is inserted into the OLO, which looks like a small home printer. The machine, equipped with a camera, takes thousands of images of the millions of cells within the sample. Software developed by the firm based on machine learning algorithms analyzes the images and provides the results in a printout or via email....Recently, Sight also initiated a pharmacy pilot program with major UK chain Superdrug to bring blood testing to its health clinics, the company said in its statement.
Basically, the Sight technology involves obtaining a couple of drops of blood from a patients and transferring them to a plastic cartridge that creates a "live" cellular monolayer. This monolayer is then scanned and analyzed with machine vision and AI techniques to count and distinguish between the various types of cells in whole blood. This technology was initially developed by the company to diagnose malaria. Although the device is currently designed to provide only a CBC, it seems to me that the technology could be extended to diagnose various types of leukemias and other blood dyscrasias in the future.
One of the key points to consider here is where this new technology will be optimally deployed. For me, the options are: (1) central hospital labs; (2) point-of-care (POCT) testing locations such as hospital clinics or physician offices; or perhaps (3) retail drug store clinics. I would rule out central labs which already have sophisticated and highly automated hematology analyzers. The deployment of POCT devices in walk-in retail drug store clinics is still unusual in the U.S. I also think that the first such instruments to be deployed in these settings will be i-STAT type handheld devices for performing routine serum chemistry panels. I thus believe that the logical and preferred location for these OLO devices, if they prove to be efficient, accurate, and cost-effective, will be physician offices and hospital-based hematology, oncology, and surgery clinics. For them, rapid CBC results from such a devices on a POCT basis would be invaluable. Ultimately, I think that this device may also yield information about white cell morphology which will make them even more useful.
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