With jitters spreading over the Zika virus, a Twin Cities-based clinical laboratory says it has launched one of the first diagnostic tests in the world to rapidly detect the exotic bug in human samples using a genetic signature.
MD Biosciences, which has North American headquarters in St. Paul along University Avenue near Hwy. 280, is already fielding calls from large health care clinics and international organizations for its $190 test for the microorganism spread by mosquitoes and sexual contact.
"We have generated much interest, both nationally and also internationally," MD Biosciences President and CEO Eddie Moradian said.
The test is not approved by the Food and Drug Administration. So far the FDA has cleared just one diagnostic test, called the Zika MAC-ELISA, which was developed by the Centers for Disease Control and Prevention and is being sent to specialized labs that are members of the CDC's Laboratory Response Network.
But the MAC-ELISA test looks for antibodies to Zika in the affected person's blood, which take at least four days to develop. The MD Biosciences test is what's known as a rapid assay designed to find a unique snippet of Zika genetic material in a person's blood, urine or plasma. That means it can be used almost immediately after a potential infection.
The MD Biosciences test is not yet offered as a kit. Rather, the company has a certification for high-complexity clinical diagnostic labs from the Centers for Medicare and Medicaid Services that allows it to develop unique tests, but only run them on authorized equipment on site.
Moradian said the closely held company, which has global headquarters in Switzerland, was able to quickly recognize the need for a Zika genetic assay and put its staff to work for six weeks, during which the test was developed.
"The type of company we are, being small, and having this capability and expertise in-house, allows us to do it," he said. "You want to know that when something like this comes, that you are able to be tested for it. We had the ability to put that kind of testing in place without having to convince a board and investors why it's a good idea."
So far MD Biosciences hasn't processed any positive Zika tests from the field, though the company is mum on how many tests it has done. Any documented cases of Zika would be reported to the state Health Department, which would report them to the CDC.
The World Health Organization has projected that as many as 4 million Zika cases will appear in the Americas this year. But the CDC says only 20 to 25 percent of adults affected will show symptoms, including rapid onset of low-grade fever, a red bumpy rash, joint pain and pink eye.
The main concern is that Zika infection of pregnant women has been associated with birth defects including microcephaly (abnormally small head size) and a rare neurological condition called Guillian-Barre Syndrome that can lead to paralysis.
The mosquitoes that can transmit Zika are not thought to be hardy enough to survive in Minnesota, said Mark Birenbaum of the American Association of Bioanalysts. But the Zika-bearing insects thrive in tropical climates like Brazil, host of the 2016 Olympics, and have been spreading through South and Central America and the Caribbean.
The CDC has identified more than 100 Zika cases in Puerto Rico that were acquired locally, and another 150 or so cases in the continental U.S. that were acquired during travel to other places, as of March 2. Minnesota has had three such cases.
The virus can also be spread by sexual contact with infected men. As of Feb. 5, the CDC was aware of three cases of possible sexual transmission of Zika by men who were showing symptoms of infection.
Given the public concern over Zika and the likely demand for rapid testing, many organizations including MD Biosciences have been working to make testing faster and more reliable. So far, the FDA says it is not exercising its discretionary power to regulate such tests.
"Laboratories are encouraged to develop Zika tests, but these tests should not be used for clinical diagnoses without FDA approval, clearance, or authorization," an FDA spokesman said in an e-mail. "Because of the public health impact … FDA is requesting that those with tests for the detection of Zika virus in patient samples submit a request for emergency use authorization to the agency."
Asked about that statement, MD Bioscience's Moradian said current FDA guidelines on laboratory-developed tests say they can be provided by approved laboratories. "These tests are provided under strict guidelines pertaining to quality control measures, appropriate controls, sensitivity and specificity," Moradian said.
The Medical Alley Association trade group applauded the rapid development of a Zika test. "Diagnostics is growing in importance to medicine, and Minnesota is responding," Frank Jaskulke, a vice president with the association, wrote in an e-mail. "MD Biosciences is part of a growing community of diagnostics firms in Medical Alley."
Moradian said that down the road, MD Biosciences plans to work toward selling its Zika detection kit to other laboratories, which will require getting strict government approvals for that particular test. Another possibility is to rapidly develop tests for other outbreaks, like Ebola.
"This was also a test to see, can we do it in a short time?" Moradian said. "And to do it to a quality that absolutely meets every one of the highest requirements. This is not just designed to be a test among tests, this is designed to be the best test. And that is where I think we succeeded."
Joe Carlson • 612-673-4779
