Co-Diagnostics Inc (Nasdaq:CODX) has won a critical victory as the diagnostics company can now sell its coronavirus detection test across Europe after clinching a coveted CE Mark for the technology from EU regulators.
The Logix Smart Coronavirus Covid 19 test is available for purchase in all of Europe after the Utah company won regulatory approval from the EU to sell the kit – which successfully identifies the presence of a new strain of the deadly virus, which has infected more than 75,000 people and caused nearly 2,130 deaths since it first struck in the city of Wuhan in China late last year.
Buoyed by the news, Co-Diagnostics shares closed up by nearly 29% to $3.93 on Monday.
“We believe Co-Diagnostics is the first US company to receive a CE-marking for a coronavirus IVD, which is a testament to the quality of our platform,” said CEO Dwight Egan in a statement.
“As the disease has spread from China, so have concerns about the global health community’s ability to contain and control it. … [We] are pleased to provide this product to those areas that are able to utilize a CE-marked IVD to protect their residents and visitors from a disease that has already affected millions.”
Co-Diagnostics shipped samples of the research-only version of its sought-after test to distributors in Italy and Germany last week in preparation for a wider product launch across the continent.
By awarding the CE mark, EU regulators confirmed the Co-Diagnostics technology meets the requirements of the European Community’s In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC). The sought-after designation allows for the immediate export and sale of the test – which is manufactured at the company’s main Utah plant – across the EU. A number of other countries will accept a CE Mark as a valid means of regulatory approval in the wake of local registration, which offers further potential for Co-Diagnostics.
The new test is already prompting admiration on Wall Street. Earlier this month Maxim analysts tagged Co-Diagnostics with a Buy rating and increased its price target to $5 from $2, citing the speed at which the company developed the detection test and its first sales in China.