WESTBROOK — A test that soon could be available to help millions of people worldwide determine whether they have the Zika virus could rely on research done at a small lab in a Westbrook industrial park. Unlike current tests that take weeks to process, the new tests would give patients quick results, potentially within 20 minutes.
ViroStat Inc., a private company on Spiller Drive, is in a race with at least one other company to develop an antibody that could be used in diagnostic tests kits, company officials said. The Zika virus has become a worldwide public health hazard because scientists have concluded that the virus can cause birth defects.
ViroStat doesn’t make the tests, but sells the antibodies to diagnostic testing companies.
The lab, which has six employees including president and founder Doug McAllister, has spent a year researching and testing and is close to the point where the antibodies could be sold to makers of the diagnostic tests. Three U.S. test-making companies are evaluating the antibodies produced in the ViroStat lab, McAllister said, and if all goes well, the Zika tests could be put on the market in 2017.
“It’s a race to be first and a race to see who has the best-quality test,” McAllister said.
The price for the antibodies is $50,000 per 4-ounce bottle. McAllister estimates that 4 ounces of antibodies could be used in millions of Zika tests, probably a blood test from a finger prick in a doctor’s office or by medical workers in the field.
“This is like selling the razor blades to the razor companies,” said McAllister, 69, who founded the company in 1985.
McAllister said the tests would be a boon to combating the virus, especially in developing countries where many have suffered from the Zika virus, which is known to cause microcephaly, a condition where babies are born with small heads. The mosquito-born Zika virus has spread throughout much of South America and the Carribbean, and cases have started appearing in the United States, especially Florida.
CURRENT ZIKA TEST HAS FLAWS
Zika virus symptoms include fever, rash, joint pain, red eyes, muscle pain and headaches, according to the U.S. Centers for Disease Control and Prevention. There is no cure or vaccine for Zika, and treatment would be rest, rehydration and pain relievers while waiting for symptoms to pass.
The mosquito that carries the Zika virus cannot live in Maine because of its cold climate, but there have been 11 cases of Zika in Maine involving people who traveled to tropical areas, contracted the virus and returned to Maine, according to the CDC. Because the mosquitoes that live in Maine can’t transmit the Zika virus, the virus can’t be spread here, scientists have said. However, a person with Zika can spread it to a sex partner.
Meghan May, an associate professor of biomedical sciences at the University of New England who has studied the effectiveness of Zika diagnostic tests for the CDC, said that if an antibody test is developed, it would be superior to the tests currently in use.
Antibodies – blood proteins – bind to the virus, signaling its presence.
Aside from the length of time to get results, an antibody test would be better than the current tests that use ribonucleic acid, or RNA, to detect the Zika virus in blood, May said. She said the RNA tests for Zika result in too many false negatives, in which the test came back negative when the patient actually had the virus. That’s partly because the Zika virus is constantly evolving, making it difficult to detect with the RNA tests, she said.
“With an antibody, it’s much less likely the virus is going to escape detection,” said May, who wrote a research paper on the topic that was published in September.
Obtaining immediate test results is always preferable for the patient, she said. For example, a pregnant woman who suspects she has the Zika virus could have a “terrifying” two to three weeks of waiting for test results.
Also, she said being able to administer the tests in the field would be beneficial in third world countries, where access to clinics and communication with patients can be difficult.
“It can be quite an ordeal to get to some of these clinics, and many people don’t have a phone,” May said. “It can become impractical to administer these tests.”
TEN MICE AND A ZIKA VACCINE
The potential new tests cost less – about $10 for a field or doctor’s office test versus $100 per test for those that have to be sent away to get the results, McAllister said.
He said ViroStat has developed antibodies used in tests for many common infectious diseases, including RSV, influenza and rotavirus. There are only a few companies in the world that do this type of research, he said.
May agreed that it’s a narrow, “very specialized” research field, and that not many labs have the expertise to do it.
Researching an antibody is a long and arduous process. Near the beginning of the research a year ago, 10 mice at a lab in Wisconsin were given a Zika vaccine. Although there is no human vaccine for Zika, there is one for mice.
In its Westbrook lab, ViroStat developed cells taken from the vaccinated mice that secrete an antibody that binds to the Zika virus. Researchers at a California lab then took those cells and injected them into other mice where they could grow more rapidly. The cells are then extracted from those mice and returned to ViroStat to be purified and packaged in 4-ounce containers.
“The work we do has to be very specific so you don’t end up with false positives or false negatives,” McAllister said. He said it’s nice to know the tests could potentially help millions of people, especially if one day a cure or better treatment for the Zika virus is discovered.
“The quicker the results can come back from these tests, the quicker medical action can be taken,” he said.