Detectachem Inc. has scored an emergency use authorization (EUA) from the U.S. FDA to market a new molecular RNA test kit for SARS-CoV-2 that provides color-coded results in about 30 minutes.

The Mobiledetect Bio BCC19 test kit uses a reverse transcription loop-mediated isothermal nucleic acid amplification (RT-LAMP) technique. Patient samples are collected using either a nasal or oral swab, added to reaction tubes containing reagent buffers, and then placed into an authorized heater or thermal cycler. The amplification process causes a color shift that can be interpreted manually or with the aid of a smartphone app.

Under the terms of the EUA, the sample collection must be done by a health care provider and the analysis must be conducted by a CLIA-certified laboratory.

From explosives to viruses

Stafford, Texas-based Detectachem has traditionally developed and manufactured detection kits for identifying drugs and explosives. With the pandemic, the company pivoted their automated colorimetric detection technology to address a new need.

“Testing for COVID-19 is a critical part of bringing the pandemic under control and safely reopening the economy in the U.S. and worldwide. Detectachem decided early-on to develop a COVID-19 test, knowing the unprecedented demand for it and our expertise in serving first responders, military, and law enforcement customers around the world who count on precision, accuracy, reliability and accessibility of our tests in large quantities.” Travis Kisner, Detectachem’s chief operating officer told BioWorld.

Using the kit, labs can run up to 96 tests per 30-minute cycle. Detectachem’s smartphone app can also be used to generate and send reports on the results, breaking down the time, date, patient information and location data for each sample.

The company has already shipped orders for more than 100,000 test kits and is ramping up their production capacity to be able to produce 1 million tests per week. Complete lab kits, which contain 96 COVID-19 tests and a thermal cycler, are priced between $6,295 and $8,295. The company is pricing the COVID-19 tests alone at about $50 each.

Their customer base for the new kits includes universities, correctional facilities, military entities, government agencies and law enforcement. These are all organizations with their own certified lab facilities that are looking for rapid, large-scale test capacity, Kisner said.

Point-of-care testing

The Mobiledetect Bio BCC19 test is just the first step in Detectachem’s testing roll out. The company is also working on developing test kits that could be used at the point-of-care – in a doctor’s office or by a school nurse – as well as a home test for consumers.

Kisner said Detectachem started the regulatory process with the most complex test and they are working their way down to a simpler version of the test. But just because a consumer test is not as complex, it doesn’t mean it was easy to develop.

“The biggest challenge is just being able to make it simple enough for people to run it reliably themselves at home,” he said.

Detectachem has been working with the National Institutes of Health (NIH) as part of the Rapid Acceleration of Diagnostics (RADx) initiative. That program is aimed at speeding up the development, commercialization, and implementation of technologies for COVID-19 testing.

The innovation that Detectachem is looking to contribute is to bring “gold standard” molecular testing – rather than COVID-19 antigen tests – to the point-of-care and home settings.

“Currently, today, we’re one of the only molecular tests that I’ve seen that has the possibility of getting into that realm,” Kisner said. “There is no home-use test, currently; there’s only home collection.”

Since home and point-of care test kits would only be used for one to five samples at a time, and would be conducted outside of a certified lab, Detectachem adjusted the kit so that it does not require pipetting samples into reagents. Instead, the samples are added to a pouch that is then crushed.

Those tests are currently being validated through clinical trials, Kisner said.

Kisner didn’t offer a price for the point-of-care and home-based tests, but said they would be offered at “affordable” prices.

“This is just the beginning in the story that we’re writing for ourselves,” he said. “We’re coming out with some great products that will help to keep people safe and healthy, returning to work, school and other important activities of daily life.”