Imagine a portable device in your home that, with a drop of blood from a finger prick, could tell you instantly your blood cell counts, vitamin levels, or whether you’re positive for a virus. That’s the dream device of many entrepreneurs who want to move laboratory-based testing to the consumer. One of them today announced a modest step in that direction.
Cambridge, Massachusetts-based rHEALTH received Europe’s CE mark to test for a blood marker for the bleeding disease hemophilia A using chemistry compatible with its portable device, the company reported today. The approval is rHEALTH’s first regulatory clearance.
Hemophilia A is a genetic disorder caused by a missing or defective clotting protein called FVIII, or “factor eight.” The condition causes people—mostly men—to bleed longer both internally and externally. Approximately 400 men born in Europe are diagnosed with hemophilia annually.
That’s a small market, but validating a portable test for any new blood marker is an achievement, and a step toward the ultimate goal of bringing diagnostics to the consumer. “We see this [regulatory approval] as a stepping stone for making a name for ourselves in the hematology space,” says Eugene Chan, founder and CEO of rHEALTH. He plans to do that “one test at a time,” he says.
Chan is aiming to build a name in a sector that is overshadowed by skepticism. Suspicion around consumer-based diagnostics arose in 2015 when it was reported that one blood test developer—Theranos in Palo Alto, California—had taken everyone for a ride. The company, launched in 2003, infamously claimed it could do practically any test on a few drops of blood collected at finger prick kiosks at drug stores. That claim turned out to be bogus, leading to lawsuits and investigations by federal authorities over the last three years. (The company has since tried to reinvent itself.)
When Theranos imploded, it tarnished the entire sector, leaving personalized diagnostics companies suddenly climbing their way out of a crater. Those companies have for years been plodding along, miniaturizing basic blood tests one at a time, with a few dozen to show for it. Now, collectively, they have a big black smudge on their record.
Chan says rHEALTH’s new regulatory clearance helps his company build credibility and distinguish itself from Theranos, which did not secure regulatory clearance for its tests. Indeed, rHEALTH’s first target—FVIII—is an analyte that may prove better suited to portable devices.
Measuring FVIII helps doctors diagnose hemophilia A and determine the dosing of medicines used to treat the disease. Such analyses are typically conducted on large equipment in centralized laboratories, involving multiple sample preparation steps that require human hands. But a hemophiliac’s FVIII levels tend to vary, and could even change from the time the blood is drawn to the time the test results come back.
FVIII tests that can be run more often, wherever the patient may be, should enable doctors to choose medication doses that better match the patient’s needs, Chan says. So his company streamlined the test in a way that reduced the sample preparation steps involved, making it compatible with a handheld device.
The company achieved that by discovering a key fluorogenic peptide that, when exposed to violet light following enzymatic reactions, fluoresces in ways that can be measured. The fluroescence of the peptide indicates the quantity of FVIII. “We think we’re the first to develop FVIII assay chemistry that is compatible with portable, small-volume blood analysis,” says Chan. “The complexity of blood factor tests precludes many others getting into the space.”
rHealth aims to add more tests to its menu, including a complete blood count, which quantifies the number of red blood cells and white blood cells in a sample. Several other companies are also building upon the menu of tests that can be performed on portable blood analyzers. That includes diagnostics multiationals such as Abbott, Philips and Roche, which are developing tests using technologies such as electrochemical detection, magnetic nanoparticles and reflectance photometry, respectively.
Among the smaller companies, Cepheid, a Sunnyvale, California-based subsidiary of Danaher, is developing quantiative tests for HIV, hepatitis C, and Ebola. And San Diego-based Genalyte has demonstrated that it can run a panel of rheumatology tests on one drop of blood from a finger stick. The company does this using photonic detectors lithographically printed on silicon chips.
Read more on IEEE Spectrum here.