Rockville (MD), July 2, 2018 —
In the wake of the failure of the highly publicized company that promised to disrupt the diagnostics industry by performing hundreds of tests on a single drop of blood. IVD market research firm Kalorama Information notes that several test companies are pursuing just that, and some of them have systems marketed. While Theranos never had technology remotely capable of fulfilling CEO Elizabeth Holmes’ claims (Theranos Edison was nothing more than a mechanical arm performing traditional laboratory chemistry inside a box), there are several new companies with technologies more in line with standard diagnostics.
Kalorama’s most recent report in Point of Care Diagnostics, covers a wide range of IVD players, some of whom are making single drop tests.
“When start-ups pitch their revolutionary new idea for a fingerstick blood test that returns results in minutes, they typically fail to acknowledge that such devices already exist,” said Bruce Carlson, Publisher of Kalorama Information.
Kalorama notes that the Abbott Laboratories i-STAT System handheld blood analyzer can perform tests for common blood gases, electrolytes, chemistries, hematocrit, blood clotting, and glucose on fingerstick samples, as well as tests for several cardiac biomarkers in venous or arterial blood. Its disposable test cartridges are FDA approved and many of them are CLIA waived. Results are returned by the device in minutes. The cartridges tests for around a dozen analytes on a single sample. Outside the U.S., Abbott sells a newer version, the i-STAT Alinity, which it claims has the largest menu of blood testing on a single device and provides results in two to 10 minutes.
Also, the epoc Blood Analysis System by Siemens Healthineers competes with the i-STAT in critical care and hospital settings. The system includes a wireless handheld reader that accepts a test card. The epoc BGEM Test Card performs multiple blood gas and metabolite tests (pH, pCO2, pO2, sodium, potassium, ionized calcium, chloride, glucose, lactate, creatinine, and hematocrit) on a single 92 microgram blood sample. It can accept capillary blood samples, as well as arterial or venous blood. The company received 510(k) clearance in February 2018 to add blood urea nitrogen and total carbon dioxide tests to its test card.
Kalorama notes some of the many companies who, undaunted by the challenges, are still pursuing tests for multiple analytes in a single drop of blood:
- NOWDiagnostics - An Arkansas-based start-up called NOWDiagnostics is working on a handheld device for fingerstick blood tests called the Lateral Flow Reader that “can be adapted for almost any qualitative or quantitative rapid test.” The company’s ADEXUSDx hCG pregnancy test received 501(k) FDA clearance in 2015. The company has been compared to Theranos, but so far its tests require a drop of blood for each analyte; it does not test for a wide range of biomarkers in one sample.
- ApolloDx - ApolloDx, a start-up based in Salt Lake City, Utah, announced in 2014 that it had developed the ApolloDx Diagnostic Platform, a 7-ounce handheld device that would eventually be able to perform multiple tests cheaply in just minutes. Three years later, in 2017, the company announced that its technology had been licensed by CibusDx, Inc., also in Salt Lake City, to be used as part of a food safety test system, an early step toward commercializing the device. The ApolloDx website describes the technology as based on a proprietary probe that binds to the analyte and can be detected and analyzed through “an electrochemical process.” Through this method, the company believes it can “detect almost any substance in a liquid sample.”
- Genalyte - One company often compared to Theranos is Genalyte, Inc., a private company based in San Diego founded in 2007. Genalyte has developed the Maverick Detection System, which uses photonics rings and silicon chips to run multiplex immunoassays on small volumes of blood to produce results in 15 minutes or less. The Maverick has not been approved for clinical use. The technology has been described in several peer-reviewed publications, but little research has been published on its performance in patients. The company points to two posters presented at the 2016 American College of Rheumatology conference describing pilot studies as its clinical evidence. One poster described a small feasibility study in which they collected blood from rheumatology patients and tested it on a Maverick chip designed to detect 8 anti-nuclear autoantibodies. The fingerstick results showed good agreement with venous samples run on the Maverick, as well as venous samples run on a FIDIS Connective 10 in their CLIA-certified laboratory. In the other preliminary study, Genalyte tested whole blood samples on a Maverick chip designed to detect 13 anti-nuclear autoantibodies and concluded they would not have missed any of the diagnoses of connective tissue disease made by a traditional laboratory.
- 1Drop Diagnostics - 1Drop Diagnostics, a start-up with offices in Switzerland and Boston, is developing microfluidic chips to “automatically detect multiple biomarkers after the addition of one drop of sample.” Its systems incorporate photonics for the detection of fluorescence light emitted by fluorescent labels. The company cites several research publications related to its capillary-driven microfluidics technology, though no clinical studies are cited. In 2017, 1Drop Diagnostics announced a partnership with Massachusetts General Hospital to work on a portable diagnostic device that could detect heart disease in primary care settings from fingerstick samples. The project received funding from the Consortia for Improving Medicine with Innovation & Technology and the National Institute for Biomedical Imaging and Bioengineering. Broadly, the company aims to develop “multiplexed assays of proteins, nucleic acids and peptides” for use in clinical research and clinical diagnostic tests, but it does not point to any particular product that is ready for commercialization.
- Seventh Sense Biosystems - If the goal is to avoid the inconvenience of a venous blood draw and the pain and variability of a fingerstick, why not find a better way to collect capillary blood? That’s the approach pursued by Massachusetts-based Seventh Sense Biosystems. Its TAP blood collection device is a single-use push button collector, about the size of the bell of a stethoscope, that draws 100 microliters of whole blood from a patient’s upper arm through an array of microneedles that rapidly puncture the skin. The device received 510k approval from the FDA for use with Hemoglobin A1c tests in February 2017, with plans to expand the test menu and ultimately offer it for home use.
“The challenges are many, not the least of which is that fingerstick blood samples have inherent problems, such as interstitial fluid mixing with the blood, hemolysis, and sample variability,” said Carlson. “But that there are so many attempts is a signal that the Theranos concept, if not an original one, is a popular goal and one shared by providers and patients.”
Carlson notes that a 2015 study by researchers at Rice University found a high drop-to-drop variation in fingerstick blood for several blood components. Also, finger pricks can be painful, which is one reason blood glucose test makers are racing to develop alternatives to fingerstick samples.
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