Editor’s note: a previous version of this story incorrectly identified Nick Traggis as Chris Myatt.
BOULDER — LightDeck Diagnostics, the trade name for mBio Diagnostics Inc., plans to use more than $15 million in recently acquired venture funding and federal contract proceeds to accelerate the development and manufacturing of a portable five-minute COVID-19 test.
In an interview on Friday, LightDeck executive vice president for corporate development Nick Traggis said the company intends to expand its current headquarters and lease new manufacturing space, using $9.9 million in venture capital it raised this year to begin buying clinical materials and broaden its footprint.
“That (funding) really is toward expanding our space, leasing additional space, and procuring additional equipment to ramp up our manufacturing capacity so that we’re ready to go when we’re able to sell these commercially,” he said.
Traggis also said the company is looking at building its own dedicated production facility along the Front Range but likely within Boulder County.
Under emergency rules from the U.S. Food and Drug Administration, Pfizer Inc. (NYSE: PFE) and Moderna Inc. (Nasdaq: MDRA) began making doses of their vaccines, and Johnson & Johnson (NYSE: JNJ) is beginning to make its vaccine version ahead of the FDA’s expected approval in March.
Those moves are coming in advance of an upcoming trial for LightDeck’s COVID-19 test, which the U.S. Food and Drug Administration could approve for use as early as the second quarter of this year, Traggis estimated. The company began clinical trials this week.
The company also announced Monday that it had landed a $5.65 million contract from the U.S. Biomedical Advanced Research and Development Authority to cover the cost of shepherding the device through the regulatory process. BARDA acts as the federal government’s procurement agency for equipment to fight bioterrorism and pandemic threats.
The LightDeck test works by placing a patient sample into a cartridge carrying a substance that dyes molecules in the sample. The cartridge is then lit up with a laser, and a sensor analyzes the resulting image for signs of the virus.
The test machine itself is small enough to be deployed in areas that require high volumes of rapid testing, such as schools, nursing homes or prisons, or for use at community testing centers.
LightDeck already deploys the technology for other uses in human and veterinary medicine, along with environmental uses such as water-quality testing.
This version of the LightDeck test determines active infection with the virus and is different from the antibody test that Mbio Diagnostics submitted to the U.S. Department of Defense before it merged with fellow Boulder company Brava Diagnostics to form what is now LightDeck.
While mass-testing won’t likely be needed for the general population in the coming months or years as much of the world starts to roll out mass vaccination programs, the LightDeck test and other COVID tests will still be needed to determine infection in those who are unable to get the vaccine for allergy reasons, or in those who refuse to take a vaccine.
Traggis also believes the pandemic has underscored the value of rapid diagnostic testing, particularly for the conditions that will exist after the pandemic ends. With the underlying technology validated, he said LightDeck and others in the rapid diagnostics industry could get to work on devices to test a range of medical issues, from strains of the common cold or routine blood work, to searching for biomarkers for cancer or cardiac risks.
“There’re many applications where, wouldn’t it be great if you could get your results in 10 or 15 minutes instead of three days, or in five minutes instead of a day?” he asked. “Those types of applications are where I think you’re going to see diagnostics, us and others, focus on to really just improve quality of life.”
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