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rHealth Gains CE-IVD Mark for Factor VIII Test, Plans to Launch More Blood Tests


NEW YORK (360Dx) – rHealth, a Cambridge, Massachusetts-based diagnostics company, announced recently that it had achieved a CE-IVD mark for its Fluorogenic Factor VIII Test kit, making the kit available for clinical use in Europe.

According to CEO Eugene Chan, the regulatory designation is just the first of more to come, as the company enters the diagnostics market with a focus on hematological testing.

"We have a deep interest in blood analysis for patients as well as in being able to measure their general health and vital signs," said Chan. "This test falls squarely into the hematology space, which is of great interest to us." In the coming year, Chan said that rHealth expects to introduce new assays addressing blood testing segments that could benefit from its platform.

Among the assays in the pipeline is a complete blood count with differential test, which Chan said is among the most common hematology tests and in general is one of the most frequently ordered tests in the clinic. "We have made hematology a priority in our company," he said.

Chan founded rHealth in 2010 as a spinout of the Cambridge-based medical technology incubator DNA Medicine Institute. The company's long-held vision is to bring diagnostics directly to patients, with the idea that patients should be able to test and monitor their health, wherever they happen to be.

That makes the company's debut offering for Factor VIII in some ways an ideal first foray into the burgeoning direct-to-patient diagnostic market, as the assay can be used to quantify Factor VIII levels in the blood of patients with hemophilia A, who often are deficient in Factor VIII. According to the World Federation of Hemophilia, while only about 400 males are born in Europe with hemophilia A annually, they require routine testing during the course of their lives. About 150,000 people suffer from the condition globally.

rHealth is, therefore, marketing its test to identify Factor VIII deficient patients and to flag those who could benefit from certain therapies, while at the same time monitoring patients' Factor VIII levels once they begin taking anti-hemophilic factor therapies.

Rather than go the conventional route of setting up a European sales office to sell the test, Chan said that rHealth is managing the European launch of its new kit directly from Cambridge, and will offer clients direct support via Internet video conference.

"We don't expect too much troubleshooting but we do offer support," said Chan. The assay is "pretty straightforward," he added.

rHealth's new test currently retails on its website for 530 ($650). The company said it currently ships the test to Belgium, Bulgaria, Cyprus, Ireland, Latvia, Slovenia, and the UK. Chan noted that these are countries that accept English-language labeling, and that the product would be made available in other languages soon.

The company does intend to make the assay available for clinical use in the US, but has not publicly set a timetable for that, Chan noted.

At the core of the assay is rHealth's fluorogenic method, which relies on a series of reactions for Factor VIII, Factor IX, and Factor X, as well as phospholipids, plus the addition of S-FLXa, an internally developed peptide, in order to produce fluorophore-dependent Factor VIII activity that can subsequently be measured in the sample. Each kit enables users to measure 288 data points, and can detect Factor VIII levels between a single range of 1 percent and 200 percent.

Chan stressed that rHealth's test provides a single calibration range, in contrast to the two calibration ranges used in conventional chromogenic two-stage assays that have a high- and low-calibration range. "The single calibration range decreases the sample preparation required for performing the assay and thus allows it to be compatible with our reader," Chan said. "The competing chromogenic assay requires a very large robotic instrument to perform the test, partly because of the complex sample preparation involved."

rHealth's assay is designed to be run on its benchtop rHealth Reader, a portable microfluidic platform that carries out sample dilution, mixing, and preparation. The reader contains lasers that measure cells and analyte-specific nanostrips using fluorescence and light scattering. The company describes its nanostrips as barcoded rectangular microparticles enabling multiplexing.

"There is chemistry, hardware, software, and our unique nanostrip reagents that allow us to perform diverse tests in a wide range of different settings," said Chan of the company's platform. "The nanostrip technology is unique," he noted, "this idea of being able to take regular test strips and make them the size of single blood cells is novel."

Much of the IP related to the company's approach has been accumulated in the past year, and includes 17 patents, either awarded or pending. In February 2017, the US Patent and Trademark Office assigned rHealth Patent No. 9,568,425, "Multicoded analytical nanostrips," which describes elongated nanostrips consisting of assay zones for measuring analytes, standards, detectable signatures identifying the assay, and a signal for determining the direction of the strip in question, as well as provides for the use of the strips in a flow cytometry assay system.

Chan noted that rHealth's European certification for the Factor VIII test covers its chemistry in a manner that it can be implemented on other platforms in addition to its reader, including different automatic robotic coagulation analyzers found in clinical facilities and research laboratories. "The Factor VIII test is for clinical labs and medical professionals," Chan said.

rHealth has not set a list price for its reader. Chan said it will cost "in the range of important consumer medical devices."  

NASA partnership

While hematology remains a priority for rHealth, its technology is widely applicable, Chan maintained. "These tests are broad tools," Chan said. "They are not focused on one medical specialty per se," he said. "This could be applied in all medical specialties."

And environments. Chan said that rHealth has been working with NASA — a supporter of the DNA Medicine Institute – to implement its technology in space for use in future manned Mars missions.

"You can imagine if you are sitting in a spaceship, and you have no access to medical care, this would give you the ability to perform a kind of diagnosis," Chan said. "It also empowers the person to perform a test." 

According to Chan, astronauts undertaking space missions are bombarded not only with space radiation, which can lead to changes in their immune systems, but also weightlessness, which can lead to a reduction in bone mass. The company's assays, therefore, would be capable of measure immunity-linked markers, such as particular cytokines, or markers related to bone health, like vitamin D and calcium.

The company is currently developing a wearable device called the Skye Sensor for the real-time continuous monitoring of vitals and health, meaning that using either the Skye Sensor or the rHealth instrument, crew members on future missions could carry out self-diagnosis without any technical training. Vitals measured with the sensor include electrocardiography and heart rate, respiratory rate, oxygen saturation, core temperature, and cuffless blood pressure, according to the company.

The rHealth platform has been tested by NASA already in a weightless environment. Chan said that NASA plans to further evaluate the system at the International Space Station sometime between 2020 and 2028, when it is decommissioned.

To make such a device available to customers in the US or EU will require a higher-level of scrutiny than conventional tests, Chan noted, involving more extensive studies and data. "The specific route is determined for the particular test in conversation with the [European Medicines Agency] and the FDA," he said.