A Bucks County life sciences company has introduced a product that determines how well a Covid-19 vaccine is working for people who have received a shot or shots.
FlowMetric Life Sciences' product, called VaxEffect, is an immune response test designed to assess and track an individual's immune response — currently and over time — to any of the Covid-19 vaccines currently available in the United States.
Renold Capocasale, CEO and founder of FlowMetric, said his contract research organization, which specializes in flow cytometry and cell sorting services, started working on VaxEffect in March 2020.
"We recognized our expertise in immunologically based cellular analysis almost obligated us to create this test," he said.
Capocasale said decades ago, when his sons were young and getting their childhood vaccines, he would ask their pediatricians for an antibody titer test. The test measures the amount of a specific type of antibody in the blood. "The pediatricians would laugh and say we really don’t do that," he said. "I never forgot that because immune responses to a vaccination are not 100% effective."
With VaxEffect, he said, people can see their individual response to whatever vaccine they received.
"Our clients are pharma and biotech companies, but we felt it was really important to address — on an individual-by-individual basis — quantifying and tracking someone's immune response to the Covid-19 vaccine they received," Capocasale said, adding that the company's platform technology can be used to analyze an individual's immune response to any vaccine — such as Gardasil, a human papillomavirus vaccine, or Shingrix, a shingles vaccine.
The project was funded by the company's senior management, some board members, and a $750,000 state Keystone Communities Program grant that Capocasale said was championed by state senators Stephen Santarsiero and Vincent Hughes.
“If the last year and a half or so has taught us anything it’s that having data and information is critically important,” said Santarsiero, during a press conference to announce the grant. “This test will not only determine vaccine efficacy of the Covid-19 vaccines available in the United States, but will lead the way for future vaccine efficacy testing.”
The test, which will initially be available through health care providers, provides users with a personalized readout of their Covid-19 antibody levels, either generated in response to a vaccine or to prior exposure to the SARS-CoV-2 virus.
With repeat testing, changes in antibody levels can be tracked over time and used for vaccine-based health care decisions, and to support the best use of booster vaccinations as they become available.
"The VaxEffect test will be especially important for patients with immune compromised conditions such as those fighting cancer, diabetes, auto-immune disorders, or those that are immunosuppressed due to organ transplantation, who may have not generated a strong immune response to the vaccine" said Grant Morgan, FlowMetric's executive vice president.
Morgan said the first test is priced at $119, and repeat testing is $99 per test. The company said while some health insurers may cover the test, FlowMetric expects users will have to pay for it out-of-pocket.
The VaxEffect test has not been reviewed or approved by the Food and Drug Administration. According to the company, the FDA has determined that no review or approval is required for such a product.
