Co-Diagnostics pivots to shipping coronavirus tests, building on solid growth clocked in 2019

The company's Logix Smart coronavirus (COVID-19) test kits have already received a CE mark from European regulators

Co-Diagnostics -
A new Food and Drug Administration will allow the company to aggressively expand the reach of its test kits in the United States

Co-Diagnostics Inc (NASDAQ:CODX) said Monday that it achieved several milestones in 2019 by strengthening its strategic relationships and product pipeline which have set the company up for further growth in 2020.

While reporting financial results for the year to December 2019, the Salt Lake City-based molecular diagnostics group noted that it had been the first US company to receive a CE-mark from the European Union (EU) for its Logix Smart coronavirus (COVID-19) test.

READ: HC Wainwright repeats 'Buy' on Co-Diagnostics after FDA policy shift

It is currently shipping orders for its test kits to 10 to 13 countries across five continents, including America, Europe, Asia and Australia, resulting in revenues for the first quarter of 2020. The firm has had inquiries from nearly 50 countries.

Moreover, a new Food and Drug Administration (FDA) policy should allow the company to aggressively expand the reach of its test kits in the United States.

"Recent events have dramatically changed our trajectory and outlook as we leverage our skill set in the field of infectious disease diagnostics, and we find ourselves in a position to have a significant positive impact on the COVID-19 pandemic," Dwight Egan, the chief executive of Co-Diagnostics, explained in Tuesday's statement.

"The work we have performed to bring a sorely-needed test to market, first as a CE-marked IVD to countries across the world and now to the United States, speaks to our commitment to providing diagnostic tools that have the potential to save lives by providing accurate diagnoses — the first step in ensuring accurate treatment," he added.

While talking about the company's financials, Co-Diagnostics highlighted that it was now debt-free, having eliminated all debt incurred in 2018 through a sale of $3 million preferred shares in January last year.

In the first quarter of 2019, the group also brought in around $5.5 million gross from a shelf offering and has recently sold shares in a series of offerings for gross proceeds of around $19.5 million.

Milestones in 2019

Among milestones reached last year, the firm highlighted its expanded license agreement with LGC Biosearch, an international leader in the extended life sciences sector and products launched under its vector control vertical, which included those to identify infectious diseases in mosquito populations.

In addition, the facility for CoSara Diagnostics Pvt Ltd, Co-Diagnostic's joint venture with Synbiotics Limited for manufacturing and sales in India, saw its inaugural opening in April last year.

In December, the company’s Saragene tests for mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C and human papillomavirus (HPV) received approval from India’s regulatory watchdog, the Central Drug Standard Control Organization (CDSCO). CoSara can now manufacture and sell these IVD products for detecting pathogens and microorganisms in India.

In keeping with a firm at this stage of its evolution, the net loss for the year to December 31 was $6.19 million, compared to a loss of $6.27 million in 2018.

Co-Diagnostics is a molecular diagnostics company that develops and markets advanced diagnostics technology.

Contact the author at [email protected]

Quick facts: Co-Diagnostics

Price: 18.55 USD

Market: NASDAQ
Market Cap: $509.33 m

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