- Develops products to detect infectious diseases in humans and animals
- Offers Logix Smart coronavirus detection test in US and globally
- Amassed balance sheet of $72.4 million
What Co-Diagnostics does:
Co-Diagnostics Inc is a molecular diagnostics company that develops products to detect infectious diseases in humans and animals. The company also develops tools for liquid-biopsy cancer screening and agricultural uses.
The Utah-based company, which operates a second location at the CoSara Clinical Laboratories (CSCL) in Gujarat, India, offers medical labs and facilities a proprietary platform for the development of molecular diagnostic tests. It also manufactures state-of-the-art diagnostics technology.
Co-Diagnostics' technology is utilized for tests designed for the detection and/or analysis of nucleic acid molecules (DNA or RNA). The company also uses its proprietary technology to design specific tests to locate genetic markers for use in industries other than infectious disease and licenses the use of those tests to specific customers.
The company's main product is its Logix Smart test which runs on the foundation of its trademark CoPrimer technology and CoDx software. The company offers four tests to detect tuberculosis and viruses - Zika, Dengue, Chikungunya, and, most importantly at present, the SARS-CoV-2 virus, which causes the coronavirus (COVID-19) disease.
Co-Diagnostics also offers a host of mosquito abatement tests in the eastern US as well as the Midwest. The tests can be tailored to all regions of the country, including multiplexed tests that include either eastern equine encephalitis or western equine encephalitis.
How is it doing:
Heading into the fourth quarter of 2021, Co-Diagnostics (NASDAQ:CODX) is rebranding its image to better reflect its growing scope, mission, and upcoming expansion into new diagnostics vertical, in addition to ongoing development in liquid biopsy for mutations associated with cancer and agricultural applications.
In 2020, the company’s earned a net income of $42.5 million from sales of its Logix Smart coronavirus (COVID-19) -- the first test developed and manufactured by a US-based company to obtain EU regulatory clearance to be sold as an in vitro diagnostic (IVD) for the diagnosis of SARS-CoV-2 in markets that accept the CE-marking. The company also won an Emergency Use Authorization (EUA) from the US Food and Drug Administration.
Since the test’s launch, the company has sold over 22 million units to hundreds of labs in over 50 countries and throughout the US.
In addition, Logix Smart ABC (Influenza A/B, SARS-CoV-2) test and its Logix Smart SARS-CoV-2 multi-gene test have been awarded CE marks from European regulators, which allows the products to be sold as IVD. The test also has been approved for sale in Mexico.
Moving ahead and driving its rebranding, the company is developing a new at-home (or anywhere else) PCR-based testing platform aimed at providing inexpensive, fast, and accurate test results in residences, schools, physicians, and dental offices, businesses, cruise ships, hotels, and other settings worldwide. It can produce rapid results within 30 minutes via the use of a smartphone.
The platform relies on the company's Direct Saliva extraction-free process and Logix Smart test reagents that are pre-packaged in saliva receptacle tubes. A person simply adds a swab or saliva sample to the receptacle tube and places the tube inside the device, which is then activated using a smartphone app.
Co-Diagnostics (NASDAQ:CODX) has submitted a EUA application to the FDA for the saliva test. The company says eliminating the extraction process has the potential to increase throughput and lower costs of testing, all without compromising quality or accuracy. In the EU, the saliva for the test has been granted an IVD for the diagnosis of the coronavirus.
The company's rebranding, which includes a new logo, website, and other related visual assets and marketing materials will take place over the next few months as additional optimization, validation, and clinical studies for the new device are completed prior to submission for FDA regulatory review.
The company also offers a mail-in COVID-19 saliva test through Walgreens Find Care, a digital health platform on the retailer’s website and mobile app. Once the kit arrives, an individual registers her test online, deposits a saliva sample in the collection vial and returns it using the prepaid FedEx (NYSE:FDX) Priority Overnight shipping package. Results are typically available within 24-48 hours delivered by text or voice message.
Meanwhile, Co-Diagnostics (NASDAQ:CODX) has completed principal design work for a PCR test that would allow researchers to identify certain mutations in newly detected variants of the SARS-CoV-2 virus. Italian researchers recently used the current Logix Smart COVID-19 Test Kit to confirm mutated strains of the virus.
Over in India, the company's CoSara JV has received clearance from the Central Drugs Standard Control Organization (CDSCO) to build and sell its Saragene COVID-19 2-gene multiplex RT-PCR test as an IVD. The CDSCO is India’s equivalent of the FDA.
In addition, the CDSCO has given the green light to CoSara to manufacture and sell its Saragene dengue and chikungunya RT-PCR tests as an IVD. The test kits are built on Co-Diagnostics (NASDAQ:CODX)’ patented CoPrimer technology for the qualitative detection of these mosquito-borne viruses.
As for the company’s finances, it reported revenue of $27.4 million, a 13.8% year-over-year increase, and net income of $9.8 million during its 2Q ended June 30, 2021.
Co-Diagnostics (NASDAQ:CODX) also had cash, equivalents, and marketable securities totaling $72.4 million as of June 30, an increase of $12.3 million from March 31, 2021.
Looking ahead, the company expects revenue to be in the range of $23 million to $25 million in 3Q 2021.
Inflection points:
- Boost availability of Logix Smart Coronavirus test kits
- Roll out new at-home PCR-based testing platform
- Win EUA approval from FDA for at-home saliva test
What the broker says:
In a note to clients on November 17, 2020, H.C. Wainwright & Co said Co-Diagnostics (NASDAQ:CODX)' Logix Smart ABC and Logix Smart SARS-CoV-2 (genes RdRp/E) multiplex, which it considers both highly accurate and affordable, could drive future domestic and international sales, this after the company obtained CE Mark for the Logix Smart ABC (Influenza A/B, SARS-CoV-2) test kit for simultaneous detection of Influenza A, Influenza B, and SARS-CoV-2, and has begun distributing it on a Research Use Only (RUO) basis to U.S. CLIA laboratories in the first week of October 2020.
“We believe the company may seek Emergency Use Authorization (EUA) and ultimately 510(K) clearance for the ABC multiplex panel. This panel could drive both near-term and long-term sales, in our view, as patients presenting flu-like symptoms are likely to be required to test for COVID-19 even after the COVID-19 spread has largely resolved,” the broker's analysts said.
They added: “We expect the company to continue to report top-line revenue similar to levels seen in 2Q20 and 3Q20. Our revenue projections for 4Q20 and the next 12 months (4Q20 to 3Q21) are $22M and $90M, respectively. The company’s operations could be sustainably profitable, in our view, particularly given the recent resurgence of the COVID-19 pandemic.“
The analysts noted that the company’s saliva-based CRL Rapid Response COVID-19 test, which its partner Clinical Reference Lab has begun selling, will also help drive top-line growth in the coming quarters.
H.C. Wainwright currently has a Buy rating on Co-Diagnostics stock with a $29 per share price target.
What the boss says:
“Our mission and opportunity to provide broad, affordable access to best-in-class, potentially life-saving diagnostic products for patients around the world is reflected in our new products, test menu expansion, and especially with our forthcoming at home and point-of-care platform,” said Co-Diagnostics CEO Dwight Egan, commenting on the company's rebranding.
“The new logo was inspired by the endless possibilities inherent in each strand of DNA and reflects the inclusivity and democratization of gold standard PCR testing for a wide array of infectious diseases worldwide.”
Contact the author: patrick@proactiveinvestors.com
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