Disaster Management Group (DMG), of Indiantown, Fla., has launched a 15-minute screening tool for COVID-19 that can be administered at drive-thru testing sites. The DMGtest, which is being offered under an FDA waiver, first rolled out in Florida and will soon be available in other parts of the U.S.
The company initially is prioritizing the test for first responders, research institutions and medical systems. Tests will be offered at temporary medical screening facilities, via drive-thru appointments – limiting exposure of ill patients to health care workers and people who don’t have the virus.
The fingerprick blood test detects exposure to SARS-CoV-2, the virus that causes COVID-19, within four days of antibody production in the blood, with 89% to 91% accuracy, according to the company. Developed under license by Biomedomics Inc., of Morrisville, N.C., it has been used more than 2 million times in China, South Korea and the U.K., beginning with the outbreak in Wuhan, Hubei Province.
The rapid IgM/IgG test is being made available under Section IV.D of the Policy for Diagnostic Tests for Coronavirus Disease-2019, which applies to tests whose validation the FDA has reviewed and accepted. Companies that receive this waiver do not need to file for emergency use authorization.
“There’s so much demand for these tests,” Matt Wideman, director of DMGtests, told BioWorld. “What we want to do is create a model of test and detect, so it’s not just about testing but about the technology of reporting those results and providing a platform for patients and clinicians to communicate.”
Tracking the outbreak
To that end, the company is partnering with San Francisco-based Salesforce to offer a front-end platform where, using an app, people experiencing symptoms can schedule a test at a drive-through center or see a doctor or go to the hospital. Once onboarded, the platform will continue to manage patients, even if they test negative, pinging them every three days to check on quarantine status, symptoms and such.
By doing this, “we can begin to track and analyze all this data … [and] if we’re seeing spikes of patients onboarding through the platform in a particular apartment community or neighborhood, we can get proactive,” Wideman said. “We can start to go on the offensive against this virus and move out of this frozen defensive position.”
He said that in the next few days, DMG will announce a partnership with one of the largest counties in the U.S., which is a “highly visible” city. The partnership – with the county’s health system and a university – calls for the distribution of 50,000 DMGtest units for first responders and the homeless, as well as a random statistical set analysis “so we can map and model the extent and veracity of the outbreak and its spread,” Wideman said.
Scaling up U.S. production
Currently, most of the tests are being produced at Biomedomics’ manufacturing plant in Nanjing, China; however, DMG is scaling up U.S. production so that more can be produced stateside.
Wideman said the company has access to millions of tests, but acknowledged that many more will be needed to conduct widespread tests of Americans.
“It’s frustrating because we are in the middle of a fire and we’re trying to fight it blindfolded because we have no visibility into the extent” of the outbreak, Wideman said. He pointed to data from South Korea and Iceland suggest that about 85% of people who catch COVID-19 process the virus and move through it with mild or no symptoms.
“Test, detect, monitor,” he said. “If we can take those three findings and communicate to a city that this is where the hot pockets are, this is what the extent of it is, as we come up and back down the curve; if we can demonstrate that the virus is diminishing … a mayor can begin to message to his community that we’ve got our arms around this,” and businesses and public spaces can begin to reopen.
New Abbott test
Separately, Abbott Laboratories reported the launch of a molecular point-of-care test that detects SARS-CoV-2 in as little as five minutes. The ID Now COVID-19 test is Abbott’s second FDA EUA for detection of the novel coronavirus, following a nod earlier this month for its Realtime SARS-CoV-2 test. The company said it will make the tests available next week and anticipates delivering 50,000 per day.
In a Tweet, Former FDA commissioner Scott Gottlieb called Abbott’s test a “game changer … delivering positive results in 5 min and negative results in 13 min.”
Meanwhile, Wells Fargo’s Larry Biegelsen lowered his 2020 forecast for Abbott by $2.9 million to $31.2 billion, citing the pandemic headwind and postponement of elective surgeries. “Our analysis assumes no catch up sales in 2020 and about 50% of the lost 2020 sales will be recouped in 2021 for every category excluding diagnostics,” he wrote.