January 20, 2021 508 PM
TEXAS — The Texas Division of Emergency Management, a state agency tasked with coordinating public coronavirus testing sites, is standing behind the Curative-brand mouth-swab test, at least for now.
Curative, whose tests were used for months at public testing sites in the tri-county, is facing scrutiny after the U.S. Food and Drug Administration warned of the risk of false negatives with the test. The Big Bend Sentinel reported on that warning last week.
In emails to The Big Bend Sentinel, a TDEM spokesperson said the agency would “continue working with vendors who utilize Curative tests to ensure that Texans have access to a wide variety of COVID-19 testing options.” The agency would also “monitor any findings and data released by Curative and the FDA,” the spokesperson said.
The FDA’s warning, the spokesperson said, “does not recommend discontinuing use of these tests.” The spokesperson also included a statement from Curative, which stressed that “a negative result does not exclude the possibility of COVID-19” and that “potential inaccuracies such as increased false negatives can occur.”
The news comes as government agencies across the country have grappled with how to best respond to the FDA’s warning about false negatives, particularly among asymptomatic people being tested. Some governmental organizations, including Los Angeles County, have cut ties with the company. Many others, including TDEM, have said they will keep using the test. The Big Bend region relied on Curative tests for months, but recently, state-run testing sites in the area have used a different test supplied by DOCS Health.
The “emergency use authorization” (EUA) that Curative received from the FDA last year says the proven efficacy of Curative’s tests is “limited to symptomatic individuals within 14 days of COVID-19 symptom onset.” But officials across the country have also offered the test to people without symptoms, including at public testing sites in the tri-county last year. That discrepancy is apparently what prompted the FDA’s warning — though the agency has not responded to questions from The Big Bend Sentinel about its warning or the Curative EUA.
Critics of the FDA, including Los Angeles mayor and Curative supporter Eric Garcetti, have argued the agency did not provide data that would justify discontinuing use of the test. In a statement to The Big Bend Sentinel last week, Curative argued its “positivity rate largely agrees with other labs.”
Before the controversy, California-based Curative had won over Big Bend residents with its ability to quickly deliver results.Tri-county officials, including at Sul Ross and in the city of Presidio, purchased batches of Curative tests for use on groups like first responders and students.
In the wake of the FDA warning, local officials are debating whether possible inaccuracies are enough reason to cancel contracts with the company. And for many — including officials at TDEM — the answer, for now at least, is no.