A portable, easy-to-use bedside device could make it easier for clinics in developing countries to test for HIV, hepatitis, syphilis and other infectious diseases.
mBio Diagnostics Inc. just brought in $3.9 million to begin commercializing its first products overseas, according to co-founder and CEO Christopher Myatt.
Those first products include a CD4 T-cell enumeration test, which is useful in assessing the immune system of patients with HIV infections, and a device that would screen pregnant women for HIV and syphilis.
According to Myatt, one thing that sets mBio apart from other companies making point-of-care diagnostic tests (like Abbott, Alverix, OraSure Technologies and Alere) is that it can do protein detection assays and cellular analysis, and potentially combine some tests into a single device. It would also allow clinics across to world to run these tests without having to send out a blood sample to a centralized lab and track down the patient later.
Starting overseas will allow the company to initially avoid long regulatory processes in the U.S. while also delivering the products where they’re needed most, in markets with severe constraints on medical resources, facilities and training. In July, the company initiated a pre-market clinical evaluation of its tests in Mozabmique.
Although initial applications of the technology put it in the hands of clinical professionals, we’ll eventually see these kinds of easy-to-use tests at kiosks in our local Wal-Marts and Walgreens, Myatt noted. “We’re trying to make technology that is highly sensitive and able to run in these settings with less training,” he said.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
mBio is a spin out of laser optics company Precision Photonics, which Myatt led until it was bought by IDEX for $20 million in April. It’s based in Boulder, Colorado.
[Photo from Flickr user US Army Africa]
