The worldwide leader of affordable molecular diagnostics services: Co-Diagnostics, Inc.

Founded in 2013, Co-Diagnostics, Inc is passionate about providing the most robust and innovative molecular tools for detection of infectious diseases, liquid biopsy for cancer screening, and agricultural applications, especially to those regions where pricing is paramount. Because it owns its platform, the company is able to accomplish this faster and more economically, allowing for wider margins while still positioning Co-Diagnostics to be the worldwide low-cost leader of molecular diagnostics services.

The company is located in Salt Lake City, Utah (US) and Gujarat (India).

Born for a purpose

Dr. Brent Satterfield, company’s founder and CTO invented the suite of intellectual properties. His passion for bringing high-quality molecular diagnostics to areas in the world that have been overlooked and underserved by other diagnostics companies, and to populations that have only had access to cutting-edge technologies if they were fortunate enough to live in regions that benefited from philanthropic subsidies, led to the birth of Co-Diagnostics, Inc.

Co-Diagnostics scientists use the complex mathematics of DNA test design to engineer DNA/RNA tests by employing algorithms that rapidly screen millions of possible options to pinpoint the optimum design for any given test. This bio-engineering approach to DNA test development is unique to Co-Diagnostics and is based on “cooperative theory,” a new generation of mathematical analytics created by Dr. Satterfield. As the technology is owned by the company, Co-Diagnostics was able to achieve this faster and more economically without burdensome royalties because of its proprietary CoDx Design platform.

The first step is the most important one: Co-Diagnostics’ first project and its success

According to the WHO’s Global Tuberculosis Report of 2017, Tuberculosis (TB) is the ninth leading cause of death worldwide, ranking even above HIV/AIDS. The estimated number of TB deaths in 2016 was 1.3 million among the HIV-negative population (although this number was an improvement from the 1.7 million deaths in 2000) with an additional 374,000 deaths from the TB-HIV co-infected population, compared to 826,000 deaths from HIV alone. As TB is one of the world’s most deadly and widespread diseases and its effects are mostly strongly felt in areas without access to cutting edge molecular diagnostics, a TB assay was the logical starting point to fulfil Dr. Satterfield’s mandate.

The first test built using its CoPrimer™ technology to receive regulatory clearance for use as an in vitro diagnostic was the Logix Smart™ Mycobacteria Tuberculosis (MTB) Test.

20% of the world’s tuberculosis cases are from India, and the country has always been a substantial market for affordable and accurate diagnostic solutions for TB. During the company’s initial years of start-up and expansion growth, India was always its proving ground to ensure it was developing high-grade diagnostics that met the demand of its key target market. Following the granting of the CE-IVD approval in 2018 and the Central Drugs Standard Control Organization (“CDSCO”, the Indian regulatory body for pharmaceuticals and medical devices) approval in early 2019, the tuberculosis test has only recently just begun its first major commercialization activities.

Success Factors

Following are the few factors for the company’s growth:

Quality: Quality is the most integral aspect of success. Co-Diagnostics’ ISO 13485:2016-certified quality management system has been instrumental in ensuring it develops products that meet market demand and make a compelling ROI proposition. Their quality system includes robust pre and post-market surveillance/feedback procedures designed to ensure its product development happens in lockstep with market demand.

Thorough Research: The most valuable advice the company would offer to peers would be the old adage that “a stitch in time saves nine;” even if it delays the onset of product development, thorough market research is an investment, and always time well spent.

Purpose of Existence: The purpose of Co-Diagnostics’ existence is always first and foremost in its motivations. “More companies die of indigestion than starvation,” says Dwight Egan, CEO of Co-Diagnostics. He further adds, “Take what you know you can do, focus on it, and make it work. Anyone can see a need and create a company to address it, but maintaining focus on your key revenue drivers long enough to make meaningful revenue is where so many other companies fall short.”

Meet the torchbearer of the company

Dwight Egan, CEO: Mr. Egan has been an officer and director since April 2013, and engaged in private investment business from February 1999 to the present. He was a senior executive at Data Broadcasting Corporation, a leading provider of wireless, real-time financial market data, news, and sophisticated fixed-income portfolio analytics to 27,000 individual and professional investors from 1995 to 1999. He co-founded and served as CEO and Chairman of the Board of Broadcast International, Inc. from 1984 to 1995 when Data Broadcasting Corporation acquired Broadcast International and created CBS MarketWatch, a leading financial news site and participated in its initial public offering. Mr. Egan’s prior experience in directing a public company and working with capital markets gives him valuable experience in advising the board on matters of finance and operations.

"We bring affordable, life-saving diagnostic solutions to the people and communities that need them most."