• Saturday, 16 February 2019

Theranos is Gone, But Single-Drop Testing is Not

ROCKVILLE, Md: While news broke late Tuesday that Theranos will dissolve, after the company's long legal, regulatory and publicity troubles, Kalorama Information said that the concept of running multiple tests from a single drop of blood is alive.

Tests are available from top IVD companies, and there are several innovative tests in development.

The diagnostics industry market research firm detailed single-drop companies in its most recent report on the in vitro diagnostics industry, The Worldwide Market for In Vitro Diagnostic Tests, 11th Edition.

"There's two major IVD companies that have models and there are several companies aiming at the concept of single-drop capillary or fingerstick," Kalorama Information publisher Bruce Carlson said. "You can bet they will all be following a different model, however. More open, more evidence-forward, looking to medical societies for peer review."

The Wall Street Journal reported that the company's current CEO emailed shareholders to announce the blood-testing company will dissolve. The founder of the Silicon Valley startup company is facing criminal charges and potentially 20 years in prison.

While the Theranos concept of a device that runs many tests from one sample was hailed as a disruptor, Kalorama Information notes that studies vary on whether capillary testing improves results or even provides true pain reduction. Also, these systems do already exist. 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.

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.

Here are some other companies who are pursuing single-drop testing:

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. At a demonstration of Genalyte's technology at the J.P. Morgan Healthcare Conference in January 2018, Genalyte's CEO talked up the Maverick's fingerstick capabilities but demonstrated the system on-site with venous blood draws. The company points to two posters presented at the 2016 American College of Rheumatology conference describing pilot studies as its clinical evidence.

In a June 2018 article in Fast Company, the company claimed it can perform 62 rheumatology tests on a 10 microliter sample of blood, but this sample is often collected venously rather than from a finger prick. Genalyte said it hopes to place its Maverick machine in rheumatologists' offices, where patients will have blood drawn and inserted into the machine (which sits on a 3-foot wide cart), then the results will be uploaded into the cloud for Genalyte to analyze remotely and a result will be returned to the patient's smart phone.

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. Similar ADEXUSDx tests for acetaminophen, heart fatty acid binding protein, methanol, salicylate, troponin I, troponin I/myoglobin, and HIV 1 and 2 have received CE marks in Europe but are not yet available in the U.S. Each cartridge takes a single drop of blood and returns a result in minutes.

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.

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 company describes the collection as "virtually painless." Blood is sucked into the collection device and the entire collector is sent to the laboratory for analysis.

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, FierceBiotech reported. CEO Howard J. Weisman told Chemical & Engineering News in 2017, "The idea of testing in a pharmacy is not going away. That's an area, we think, that is ready for significant growth."

Kalorama details the $65 billion-dollar IVD industry in its new report The Worldwide Market for In Vitro Diagnostic Tests, 11th Edition.


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