FYR Diagnostics Developing Fast, Low-Resource COVID-19 Test

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Apr 14, 2020, 23:27 ET

MISSOULA, Mont., April 14, 2020 /PRNewswire/ -- FYR Diagnostics, a Missoula, Montana-based molecular diagnostics company focused on developing next generation tests for the early detection of human and agricultural diseases, announced that it is developing a test for COVID-19 viral infection that is more cost effective than existing rapid tests, while also being scalable and suitable for use outside of a medical facility in low-resource environments.

"We are proud to be doing our part to address the COVID-19 crisis," said Chris Booth PhD, CEO of FYR Diagnostics. "Our team is working around the clock to develop Adaptive Low Resource Testing (ALRT), a rapid diagnostic test for SARS-CoV-2, the virus that causes COVID-19, that can be used in hospitals as well as at testing sites in the community."

Currently, the FDA has approved two different types of COVID-19 tests: antibody tests that detect an individual's immune response to the virus, and viral tests that detect the presence of the SARS-CoV-2 virus itself. Both types of tests are crucial tools in fighting the spread of COVID-19. Antibody tests can determine who has been previously exposed to the virus and may be immune, but they are not effective in identifying those who are newly infected because antibodies take many days to develop after exposure. Tests that directly detect the virus, on the other hand, are effective at finding who has a potentially active and contagious infection even in asymptomatic individuals but are not effective at identifying those who have recovered from the virus.

Although several viral detection diagnostic tests have been approved by the FDA and are being used across the country, supply chain and equipment shortages are keeping this testing capability from being used on a mass scale. FYR Diagnostics' ALRT test opens this bottleneck through alternative reaction components and technologies that do not require scarce equipment or costly specialized devices. The ALRT test is designed to be low cost, simple to administer without specialized training, and suitable for use at low-resource testing sites beyond hospitals and clinics. It can produce a yes/no test result in 30-40 minutes.

"Insufficient testing capacity here in Montana and throughout the US is amplifying and prolonging the COVID-19 crisis while putting more lives at risk," says Mike Goguen, Executive Chairman of FYR Diagnostics. "FYR's highest priority is to quickly enable mass COVID-19 testing in our home state, and then expand elsewhere."

"We still have some work ahead of us," says Sarj Patel PhD, President of FYR Diagnostics. "Our goal is to obtain Emergency Use Authorization approval from the Food and Drug Administration for our test. This would permit us to deploy our test on a broader scale in Montana."

FYR Diagnostics has received state and federal research grants, as well as private funding from Two Bear Capital, a top-tier venture capital firm based in Whitefish, Montana. FYR's efforts to produce a scalable, low-cost COVID-19 diagnostic test for Montana has been supported by state leaders on the frontlines of the COVID-19 fight spanning industry, academia, government and healthcare.

About FYR Diagnostics

FYR (pronounced "Fire") Diagnostics is a Montana-based company focused on developing and commercializing novel technology for diagnostics and testing in human health, life sciences, and agriculture. FYR Diagnostics is currently developing diagnostic solutions for skin cancers, seizure disorders, agricultural diseases, and neonatal-associated syndromes. For more information, visit fyrdiagnostics.com.

Contact
FYR Diagnostics Inc
1121 E Broadway St
Missoula, MT 59802
[email protected]

Forward-Looking Statement

This news release of FYR Diagnostics Inc, Missoula, MT, USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

SOURCE FYR Diagnostics