When will the U.S. market be ready for disruptive mobile health diagnostics tools? That’s a question at the front of the mind of mBio Diagnostics CEO Christopher Myatt. The company is gearing up for the commercial launch in sub-Saharan Africa this year of its mobile, point-of-care diagnostics platform to better monitor the health of people with HIV. By obtaining CE Mark approval to commercialize its product outside the U.S., it hopes to gather additional data to ease headwinds to regulatory approval in the U.S. in the long-term.
Its CD4 T-cell enumeration test assesses the strength of HIV patients’ immune systems by getting the white blood cell count. The company views the technology as meeting an unmet need — as 33 million people are infected with HIV worldwide.
In an interview at the JP Morgan Healthcare conference, Myatt said mBio is working with diagnostic partners who have existing businesses in countries such as Mozambique and Kenya.
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What distinguishes the company’s diagnostic platform from other companies in this space is that it can do protein detection assays and cellular analysis. It would also allow clinics worldwide to run these tests without having to send out a blood sample to a centralized lab and track down the patient later.
mBio also has a second diagnostics platform — an immunoassay system that’s designed to give a simultaneous and accurate measurement for multiple conditions using a single sample, according to its website. Initial indications have focused on infectious diseases applications. The first is a combined HIV/syphilis/hepatitis C virus serology system evaluation. It has also patented a diagnostic test for TB. .
University of California at San Diego and Seattle-based PATH’s Center for Point-of-Care Diagnostics for Global Health are among its collaboration partners. It provides the device to international aid groups and government health departments.
mBio plans to take a selective approach in choosing which diagnostic tests it will seek clearance for in the U.S., with hepatitis C a strong contender. “This technology translates very well with U.S. healthcare demands,” Myatt observed.
Clinicians tend to be the ones who order tests and so would be the initial users of the technology, but Myatt said the technology is designed to that nonclinicians could administer the test. Although he sees its potential to disrupt healthcare delivery, he’s unsure how long it will take to penetrate the U.S. market.
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