Medical testing company Co-Diagnostics said Monday that its coronavirus test kits are now available for sale to laboratories in the U.S., an announcement that sent its stock soaring nearly 35%
The tests from Co-Diagnostics, which has also developed screening technology for Zika and tuberculosis, said the tests are available for purchase by labs in the U.S. that are certified under Food and Drug Administration guidelines called the Clinical Laboratory Improvement Amendments (CLIA).
The FDA over the weekend changed its policies to address the coronavirus outbreak and speed up the diagnosis of people who may be infected. The increased testing is expected to reveal more positive COVID-19 diagnoses across the U.S.
The coronavirus has infected at least 87 people in the U.S., six of whom have died. The disease has killed more than 3,000 people globally and infected 89,000, mostly in China.
The new guidelines allow FDA-approved labs to start using the diagnostic tests before the agency has assessed them. That could speed testing and, health experts hope, help contain the spread of the virus. Previously, labs had to wait for FDA approval before ordering tests.
“We believe this change will allow the diagnostics industry to respond to the developing situation much more rapidly and effectively,” Co-Diagnostics CEO Dwight Egan said in a statement.
Co-Diagnostics has already sold thousands of tests to labs in Europe, where they are approved for sale, Egan told CBS MoneyWatch. The Salt Lake City-based company is in discussions to sell its test kits to labs across the U.S.
“Previous to the FDA announcement, we could already sell our test in Europe and many other countries. The change makes it so we can make test kits available to CLIA labs in the U.S. for use under the FDA guidelines,” Egan told CBS MoneyWatch.
Using a person’s fluids taken from a nasal or other swab, the company’s CE-IVD Logix Smart COVID-19 test kit employs a mathematical algorithm and AI to detect the disease. It delivers results in about 90 minutes, Egan said.
Co-Diagnostics said it’s maintaining what it calls a “compassionate pricing model” that’s used to set the cost of other drugs. The test kits typically sell for less than $10, depending on the quantity of kits and where they’re sold.
“If you have a test but its price is out of range, it’s irrelevant for a population. We haven’t tried to jack up the coronavirus test price because it’s a public health emergency,” Egan said.
The company’s Utah facility can produce about 50,000 test kits a day. “We can certainly handle whatever kind of demand is foreseeable in the U.S.,” Egan said.
Co-Diagnostics kits are being used in Italy, where there are more than 2,000 confirmed case of the virus. Fifty-two people in Italy have died from COVID-19.
The Centers for Disease Control and Prevention have also developed a test that’s being used to evaluate patients in the U.S. U.S. Secretary of Health and Human Services Alex Azar has said the U.S. has tested 3,600 people, and has also called for a radical expansion of testing capacity in the U.S.
Egan said his company is ready to provide the government with its tests as needed. “We aren’t in competition with the CDC. We are supportive of what they are doing. We are just raising our hand and saying we are here as well and ready to supply tests if you need them.”
Kelly Wroblewski, director of infectious diseases at the Association of Public Health Laboratories, told CBS MoneyWatch that as of Monday morning, roughly 40 of its members had ordered test kits from the CDC. She expects 100 of its member labs — all those that qualify — will order kits from the CDC.
“We are more optimistic than we were last week, and we are excited about the FDA guidance that allows for greater expansion of drug testing,” she said.
It’s unclear if any of those labs will use tests manufactured by Co-Diagnostics.
