Zika Virus Fears Spur Diagnostics Race as Women Seek TestingBy
Florida doctors see demand skyrocket since Miami outbreak
Orasure, Chembio developing point-of-care diagnostics
Local outbreaks of Zika virus have sent demand for tests jumping in Florida and sparked interest in new diagnostics for the disease that threatens the health of newborns.
At least 47 people in the state have been infected with Zika via mosquitoes, most of them in two areas of Miami where the virus is known to be spreading. Health officials have warned pregnant women to avoid those neighborhoods and seek testing if there’s a possibility of infection because the virus can cause brain damage in fetuses.
“My patients are on high alert and, for the most part, are all getting tested,” said Ellen Schwartzbard, an obstetrician and gynecologist at South Miami Hospital who refers as many as six patients a day for tests. Local health departments offer free testing to pregnant women, but some who are planning pregnancy are willing to pay out-of-pocket, she said.
While standard Zika tests cost from $120 to $780 and take up to a week to return results, companies developing faster, cheaper assays have gained attention during the outbreak. OraSure Technologies Inc. and Chembio Diagnostics Inc. are marketing and developing screens that may cost as little as $40 and can provide results in as little time as 15 minutes.
In Florida, “the demand is enormous,” said Aaron Elkin, a Broward County obstetrician who said he tests 10 to 15 patients daily. “Men are also wanting to do the test.”
At least 2,517 Zika cases have been reported in the mainland U.S., most of them in travelers to more severely affected countries. While mosquito-borne infections may spread beyond Florida to other U.S. states, estimating the size of the testing market remains difficult, said Mark Massaro, an analyst at Canaccord Genuity.
Roughly 30 U.S. states are home to strains of mosquitoes that carry the virus, said Aileen Marty, a Florida International University professor specializing in tropical medicine and infectious disease pathology.
“Any of those states can become a new Zika zone,” she said in a telephone interview.
Chembio, based in Medford, New York, said last week that it won a U.S. Health and Human Services Department contract worth as much as $13.2 million to help develop its Zika test. Doctors can administer it in their offices and provide results about 15 minutes later.
Chembio gained a permit last month to sell the test in parts of the Caribbean, where Zika is widespread, and Europe, according to Chief Executive Officer John Sperzel. The company is also seeking U.S. market clearance, he said.
Chembio is the only company seeking a WHO recommendation for a rapid test, and the company’s revenue could double over the next year or two “from the Zika sales ramp alone,” said Bill Bonello, an analyst with Craig-Hallum Capital Group LLC who rates the stock buy. Chembio’s 2015 revenue was $24.3 million.
OraSure Technologies won a contract worth as much as $16.6 million from HHS to develop a fast point-of-care test. The assay adds to “a growing number of catalysts for the stock that we believe are underappreciated by investors,” Canaccord’s Massaro wrote Aug. 23 in a note. A spokesman declined to comment on the potential size of the market.
The company could seek approval for emergency use in the U.S. as soon as December, said Massaro, who rates the shares buy. In the U.S. and other wealthy countries, a point-of-care test might cost about $40, according to Massaro.
The most immediate opportunities for Chembio include Brazil, where a test could sell for at least $2, and the Caribbean, Bonello said.
While Laboratory Corp. of America Holdings and Quest Diagnostics Inc. get most of Florida’s Zika testing business, the surge in cases won’t have a noticeable effect on the diagnostic giants, said Nicholas Jansen, an analyst with Raymond James. Representatives for the companies declined to say how many Zika tests they’ve performed and said they have the ability to expand laboratory testing for the virus if needed.
Theranos Inc., the controversial Silicon Valley blood-testing startup, confirmed Tuesday that it withdrew a request for emergency U.S. clearance of a Zika test. Regulators had found problems with how the company collected patient data, the Wall Street Journal reported.
Meanwhile, the number of infected pregnant women in Florida continues to mount, rising to 78 on Aug. 30 from 43 on July 19.
“The testing is critical,” said Broward County’s Elkin. “We’re seeing more and more Zika pregnant patients positive.”