Co-Diagnostics, Inc Receives FDA Emergency Use Authorization for COVID-19 Test

Salt Lake City, Utah – April 6, 2020 – Co-Diagnostics, Inc. (Nasdaq:CODX), a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced today that its Logix Smart™ Coronavirus COVID-19 Test has obtained Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) to be used for the diagnosis of SARS-CoV-2. The Company’s test can be used by clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) to detect the presence of the virus that causes COVID-19, and is available for purchase from the Company’s Utah-based ISO-13485:2016 certified facility.

Co-Diagnostics began offering its COVID-19 test to some U.S. CLIA labs in March 2020 as a result of the FDA’s policy for diagnostic tests for COVID-19 during the current public health emergency. Previously, the Company had initiated sales of its CE-IVD test to the European Community, and to other global markets that accept a CE marking as valid regulatory approval following routine local product registration.

CEO of Co-Diagnostics Dwight Egan commented, “We believe that this authorization confirms the quality and performance of our COVID-19 test, and that it is a significant step in opening more doors and helping this test to reach an even wider audience. Many experts agree that accessibility of widespread testing is an important element to ‘flattening the curve’ as U.S. cases of COVID-19 continue to rise, and that increased testing throughput is vital to achieve this objective. We look forward to continuing our goal of increasing the availability of advanced, high-throughput, and cost-effective COVID-19 testing solutions both close to home and across the globe.”

The Co-Diagnostics Logix Smart™ Coronavirus COVID-19 Test uses the Company’s patented CoPrimer™ technology to target the RdRp gene of the SARS-CoV-2 virus. The advanced nature of CoPrimers has allowed Co-Diagnostics to design a highly-specific, single-well PCR test, allowing higher throughput over tests that require multiple wells. Co-Diagnostics believes the lower cost of reagents in the Company’s single-well test will help hospitals and laboratories to process more while paying less, benefiting healthcare providers and patients alike.

Co-Diagnostics, Inc Completes Successful Clinical Evaluation Required for FDA Emergency Use Authorization

Company accelerates U.S. sales of COVID-19 test pursuant to new FDA policy

Salt Lake City, Utah – March 19, 2020 – Co-Diagnostics, Inc. (Nasdaq:CODX), a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced today that following a successful clinical evaluation of its Logix Smart™ COVID-19 Test, the Company will begin fulfilling orders from a wider array of U.S. customers, including thousands of additional laboratories in the country who can now run the Company’s test as a clinical diagnostic.

A recent FDA policy change aimed at expediting the availability of COVID-19 diagnostics has allowed the Company to expand domestic sales of its test immediately. Co-Diagnostics’ COVID-19 polymerase chain reaction (PCR) test can yield results in under two hours, and successfully passed the clinical evaluation as requested in the policy change, showing sensitivity of 100% and specificity of 100% in detecting SARS-CoV-2, the virus which causes COVID-19, without demonstrating any cross-reactivity with other coronaviruses.

Dwight Egan, Co-Diagnostics CEO, commented “Our Logix Smart COVID-19 test has already been deployed on a global basis to five continents as well as to U.S. CLIA labs that meet certain requirements, and we are prepared to provide an even greater number of U.S. laboratories and patients access to our test as a result of the new FDA policy. The demand for reliable, high-quality COVID-19 diagnostics has never been greater, and it continues to grow daily as this disease affects not just patients afflicted with it and their families, but the entire nation as a whole.

“We believe the excellent performance of our COVID-19 test combined with affordable pricing will place it in the vanguard of available testing alternatives worldwide. We have scaled up both our domestic and international production capabilities to meet demand, including receiving a license to manufacture our COVID-19 test in our facility in India, which more than triples our capacity. The Company’s Logix Smart COVID-19 test, built on our patented CoPrimer™ technology, has the potential to improve the quality of life of millions of Americans by providing access to a prompt, accurate, cost-effective test. We are gratified to be in a position to make available a test that can provide results in less than two hours, which we believe is among the fastest turn-around times of any test currently on the market.”

The new FDA policy permits Co-Diagnostics to begin U.S. sales of COVID-19 tests immediately while it awaits FDA clearance under Emergency Use Authorization (EUA). The Company’s application for EUA is currently under review by the FDA.

Co-Diagnostics, Inc Receives CE Mark for Novel Coronavirus Test

Logix Smart™ COVID-19 Test now available for export from the United States as a CE-marked IVD

Salt Lake City, Utah – February 24, 2020 – Co-Diagnostics, Inc. (Nasdaq:CODX), a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced today that its Logix Smart™ Coronavirus COVID-19 Test has obtained regulatory clearance to be sold as an in vitro diagnostic (“IVD”) for the diagnosis of SARS-CoV-2 (COVID-19) in markets that accept CE-marking as valid regulatory approval, and is now available for purchase from the Company’s Utah-based ISO-13485:2016 certified facility.

The Declaration of Conformity for the Logix Smart COVID-19 test confirms that it meets the Essential Requirements of the European Community’s In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC), permitting export and sales of the product as an IVD to commence immediately in the European Community. Co-Diagnostics shipped samples of the Research Use Only version of its test to distributors in Italy and Germany last week, which allowed future customers to confirm the quality and sensitivity of the product prior to the IVD being available, and the Company to accelerate the sales efforts of its diagnostic. Many other global markets also accept a CE marking as valid regulatory approval following routine local product registration, which allows sales of the Company’s IVD into these areas.

Dwight Egan, Chief Executive Officer of Co-Diagnostics, remarked, “Co-Diagnostics has received overwhelming interest in our novel coronavirus diagnostic from all over the world since first announcing its development a month ago. As the disease has spread from China, so have concerns about the global health community’s ability to contain and control it. The first step in containment is a prompt, accurate diagnosis, and 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.

“We believe Co-Diagnostics is the first U.S. company to receive a CE-marking for a coronavirus IVD, which is a testament to the quality of our platform. The rapid development of our COVID-19 test was made possible thanks to our proprietary design process and patented CoPrimer™ technology platform. We look forward to scaling up production to meet global demand with this regulatory clearance in place, and to obtaining approvals from other bodies that will allow us to further increase the reach of this invaluable diagnostic tool.”