Two Bahamians are awaiting the green light from the United States’ Food and Drug Administration (FDA) to be able to widely distribute a COVID-19 serological rapid test kit throughout the United States. In the meantime, they want to provide Bahamian government officials and local health officials with the test kits, which have already been approved to be sold within the European Economic Area (EEA) and by South Korea’s Ministry of Food and Drug Safety.
Bahamians Aisha Bowe and Matthew Rose, who both reside in Washington, D.C. with their partner Shannon Clark of California, have already had their COVID-19 rapid test short-listed by the FDA and are, therefore, now able to sell them to labs within the United States.
According to the team, their tests are already being sold in Brazil, Chile and Argentina. In addition, they have begun the registration process for the tests in the Philippines, Japan, Columbia, Ecuador, UK, Malaysia, Kazakhstan and Italy.
Bowe said their company Mahiri Med (Mahiri means skillful in Swahili) would like to provide the Bahamian government with free kits to vet and test. Bowe is also the founder and chief executive officer of STEMBoard, a tech company that creates smart systems and software solutions for private and public sector clients.
“We recognized that in order to successfully combat the pandemic, we would need to enable reliable, affordable and quickly distributable testing and right now, what you’re seeing is a lot of testing is based on the molecular [approach]; the swab,” she said.
“Because of the way that COVID-19 is spread, once you get a swab and you’re negative, that doesn’t mean you’ll be negative in four or five days once you have been exposed to someone. The need to have testing that you can go to repeatedly is beginning to present itself as a primary driver, between can we reopen the economy and can we maintain safety.
“We just want to provide these to the Bahamas government to conduct the testing, so that they can say, ‘is this to our quality standard or not’ and then they can make the decision to move forward with it. However, it can be hard in a time like this to cut through the chatter and elevate the public discourse because so many people are only thinking about the nose swab as the primary testing mechanism.”
The group said they started the company – which also provides ventilators and personal protective equipment (PPE ) like masks, gowns and face shields – because they saw the need for a viable test that would provide quick results.
The Mahiri Med test kit returns results within 15 minutes by delivering blood from a finger prick to a testing mechanism that looks for antibodies. It reads much like a pregnancy test, the company’s founders said.
The tests are the result of a partnership with a Korean pharmaceutical company, Rose said, adding that their partner has the capacity to produce up to 14 million of the rapid tests per month on the high end.
Rose has ten years of experience in the areas of preparedness and response with the Biomedical Advanced Research and Development Authority, where he focused on medical countermeasures.
Clark, who has more than ten years of experience in medical device quality engineering, design, risk management, compliance and auditing quality systems, said the FDA has already reviewed Mahiri’s submission and found the test to be accurate.
“They confirmed that they are very highly accurate, but they haven’t offered a full authorization yet because they haven’t gotten around to reviewing the whole package,” said Clark.
“We are celebrating the fact that it is listed on the FDA’s website.”
Clark and Rose noted that rapid tests received a bad rap early on in the pandemic because there were so many inaccurate and faulty tests being brought to market. Their test has made it to the FDA’s shortlist.
Clark said now is a good time for an accurate rapid test, given that evidence shows that many new infections are being spread by asymptomatic carriers of COVID-19.
“It’s quite silly that we’re talking about using thermometers to see if people have fevers,” she said.
“That really feels like an unsophisticated approach, because 20 percent or even more of the population has COVID-19 and is asymptomatic. They are still refining those numbers.”
The group agrees that this kind of test will be useful for sending children back to school and ensuring that tourists entering a jurisdiction are indeed free of COVID-19.
While tourists coming to The Bahamas as of July 1 have to produce a COVID-19 negative test to enter the country, the test can be no more than ten days old and provides the risk that a person could become infected between the time they get their results and take their trip.
“Our primary focus is we want to get kids back to school,” said Bowe.
“The second is tourism, we need to make sure that an economy that already sustained quite a hit with Hurricane Dorian continues to survive.
“I’m very worried about the long-term impact to the tourism economy in The Bahamas.”
Bowe added that she and Rose, who have been friends for several years, began Mahiri out of a loyalty to The Bahamas and being strong models of what Bahamians can achieve.
“The reason why I wanted to get involved in this organization with Matthew is because it’s two individuals who are heavily invested in The Bahamas saying, ‘Hey, we know the government is looking to combat this pandemic and we as private citizens have a role to play and we can help’,” she said.
“It shows that we don’t just have to wait for someone to provide something to us, we can get together, we can organize and maybe we can help the government to help us.”