The unknown surrounding the COVID-19 crisis has forced our world to grind to a halt.
The disease is spreading rapidly. A lack of tests means that even people who exhibit the signs of the coronavirus don’t know for sure if they’ve had it.
But a Franklin company is working to provide answers to some of those unknowns.
B2S Life Sciences, which develops tests and provides services for the pharmaceutical and diagnostic industry, has started work on a blood test that would recognize COVID-19 antibodies already present in the body. Those antibodies would mean that a person had already contracted the disease, and would not be a danger to further the spread of the virus.
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An accurate, wide-spread test would clarify which people could safely return to work or be out in public.
This was a way for B2S to use its unique resources to help deal with the crisis, said Aleks Davis, CEO of B2S Life Sciences.
"When we started to really understand the impact that this was making and was going to have on the globe, I felt like it was our responsibility to do this. We have the capabilities; we have the people to do it; we have the technology to do it. We wanted to be a part of that whole conversation," Davis said. "Community members are making masks for people. Car manufacturers are making ventilators. Why should we not do this?"
B2S Life Sciences, founded in 2016, provides pharmaceutical and diagnostic biological reagents, which are used to test for chemical reactions. Their bioanalytical services and software helps the pharmaceutical industry develop drugs.
The company can thoroughly test emerging drugs throughout the development process, so pharmaceutical companies can provide the proper information to regulatory organizations such as the Food and Drug Administration, Davis said.
"If you have a new drug, you need to test that drug. And if it’s new, there’s no test out there for it. So we make a test that can be used specifically for that drug, so it can generate the data that the FDA or whatever regulatory body need," he said.
Creating blood tests that search for a disease is not typically part of B2S Life Sciences’ offerings. But the capabilities, equipment and technology that it has positions the company to develop a serology test for COVID-19.
A serology test analyzes blood to search for antibodies or proteins that reveal the presence of COVID-19. The tests would help determine who may have had the disease, even if they never had any symptoms.
The presence of those antibodies would mean that person is essentially immune to the disease Identifying those people could help ease the restrictions that have locked down the country, Davis said.
Serology testing for the virus is at an increased demand to better quantify the true number of COVID-19 cases, according to the Johns Hopkins Center for Health Security.
Tests that are currently available throughout the world, such as the RT-PCR test used to find those who have the disease, only reveal the presence of viral material during infection, and does does not indicate if a person was infected and subsequently recovered, the center said.
"(Serology tests) can give greater detail into the prevalence of a disease in a population by identifying individuals who have developed antibodies to the virus," according to the center.
In mid-March, the FDA put emergency regulations in place for laboratories to apply for and receive authorization on these types of tests.
"Right now, we have companies making tests that tell you if you have the illness. That’s not really our forte. We can develop a test that tells you who has had it and recovered from it, and who can safely go back to work," Davis said. "We think that little piece of it lines up with our capabilities."
The test would also help fully understand the impact the disease has had in the aftermath of the pandemic, according to an expert response created by Indiana’s COVID-19 Evidence-Informed Response Team.
"COVID-19 serology would definitely be a useful tool to assess the scope of the pandemic post-crisis. One must remember, however, that post-epidemic serologic surveys will only capture data on individuals who were either not infected or those who were infected but survived the disease," the report said.
A group has been formed within B2S, led by a board-certified clinical chemist as a director. The company applied for a license to analyze patient tests in addition to developing the tests, which was approved.
Their researchers have followed the requirements laid out by regulatory groups, including ensuring, statistically, that the tests are measuring specifically and accurately.
"The danger would be false positives, putting someone back in the workforce who is not immune to it. So we have be very, very specific and put the tests through a lot of rigor that there is an incredibly low chance of that happening," Davis said.
As the tests are still in development, no concrete time table is set for when the tests might be available. In the coming weeks, B2S will need to perform the appropriate evaluation to determine that their tests are accurate and reliable, meaning that the test is put through a rigorous validation process and documented to demonstrate reproducible results.
Davis hopes that it could be ready in the next six weeks.
The next challenge for B2S is getting the tests out into the community. The tests will be open to the public but most likely through a healthcare provider’s or employer’s direction, Davis said. The cost of what the test would be is not currently known, he said.
The company is looking to partner with a larger organization that can facilitate the testing of thousands of tests a day to meet the need, and has reached out to several organizations locally and nationally to find the right collaborator, he said.
"We’re typically a service provider. We don’t typically make things and try to sell them. People tell us what they need made. So we are putting resources in and making this investment, sort of not knowing if there is going to be any kind of a return on it. Not even financially, just a return on it in terms of, does it get used," Davis said. "In that sense, it’s different from what we do."
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"When we started to really understand the impact that this was making and was going to have on the globe, I felt like it was our responsibility to do this. We have the capabilities; we have the people to do it; we have the technology to do it. We wanted to be a part of that whole conversation. Community members are making masks for people. Car manufacturers are making ventilators. Why should we not do this?"
— Aleks Davis, CEO, B2S Life Sciences