Co-Diagnostics Inc (NASDAQ:CODX), a molecular diagnostics company with a unique platform for the development of diagnostic tests, revealed Thursday that Dr Brent Satterfield, the company’s co-founder and chief scientific officer, will address a meeting convened by the Bipartisan Commission on Biodefense, in Washington, focused on national biodefense in light of the response to COVID-19.
In a statement, Salt Lake City, Utah-based Co-Diagnostics said the meeting is set for March 18, and will evaluate the response to the coronavirus outbreak and implications for preparedness.
Co-Diagnostics is the first US company to receive a CE-mark for its proprietary COVID-19 diagnostic test. It is currently shipping orders for its test kits to 10-to-12 countries across five continents, including America, Europe, Asia and Australia. It has also had inquiries from nearly 50 countries. The firm’s Logix Smart COVID-19 screening test kits are also making their way to Italy, the most severely impacted country in the European Union.
The speedy development of the COVID-19 test was made possible by a unique, proprietary design process and patented CoPrimer technology platform that was invented by Dr Satterfield.
In a statement, Dr Satterfield said he would share the details of how the company developed its COVID-19 test so quickly and efficiently with the Bipartisan Commission on Biodefense.
“The company’s proprietary platform serves as a template to develop other tests needed now, and in the future as new pathogens surface in our interconnected world. Our current test detects COVID-19 with a high level of specificity to distinguish it from similar viruses,” said Dr Satterfield.
“However, in addition to recently being declared a pandemic by the World Health Organization, the virus that causes COVID-19 is also believed to be mutating. Co-Diagnostics’ patented CoPrimer technology is uniquely suited to quickly develop multiplex assays that can identify multiple mutations of the virus in a single test when the need arises,” he added.
Capability for rapid development of multiplexed tests
In what is reassuring for the world, Dr Satterfield said the “rapid, efficient development of multiplexed tests is a core competency” of Co-Diagnostics.
Prior to founding Co-Diagnostics in 2013, Dr Satterfield developed new diagnostic platforms for the US Department of Homeland Security, the National Biodefense Analysis and Countermeasures Center, the United States Army Medical Research Institute of Infectious Disease, Sandia National Laboratories, and the California Department of Public Health.
Co-Diagnostics continues to ramp up production to meet surging global demand. It is also seeking emergency use clearance for use as an in vitro diagnostic by the US Food and Drug Administration (FDA) as well as by the CDSCO in India, both of which are expected to further increase the domestic and international reach of the cost-effective diagnostic tool.
Increase in product shipments
The company has been seeing an increase in product shipments of its Logix Smart COVID-19 screening test following the FDA’s decision late last month to allow labs that meet a set of standards known as the Clinical Laboratory Improvement Amendments (CLIA) to use coronavirus detection tests that have been developed and validated before the FDA has reviewed their Emergency Use Authorization (EUA) submission.
Previously, labs seeking to use coronavirus tests had to wait for specific clearance from the FDA.
In view of the continuing — and rapidly accelerating — COVID-19 infection spread worldwide and initialization of shipments to labs in the US and around the world, investors have snapped up shares of Co-Diagnostics.
The company’s stock was up 18.8% to $15.65 in the pre-market session after the stock nearly doubled when it closed on Wednesday.
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