Co-Diagnostics | Top In-Vitro Diagnostic Technology Solution Company 2019

MedTech Outlook Magazine

Co-Diagnostics
Making Way for Affordable Diagnostics

Dwight H. Egan, CEO, Co-DiagnosticsDwight H. Egan, CEO
It was in 2013 when Dr. Brent Satterfield, a bioengineer and mathematician, pioneered the application of engineering mathematics to molecular diagnostics. With expertise in a specific type of complex mathematics called Cooperative Theory, Dr. Satterfield founded Co- Diagnostics to devise a proprietary molecular diagnostics technology that leveraged enhanced detection of genetic material for disease detection and life sciences research. Little did he know that in the coming years his technology would pave the way for innovation in the detection of infectious diseases, liquid biopsy for cancer screening, and agricultural applications, all areas where pricing is paramount.

Fast forward to today, with Dwight H. Egan at the helm as the CEO, Co-Diagnostics continues to create ripples in the industry with CoPrimers—the company’s leading-edge, patented platform technology designed for enhancing the output of molecular diagnostic tests conducted via real-time polymerase chain reaction (PCR) tests. “Scientists have long been challenged with primer-dimers (PD)—a potential by-product formed during PCR—when running diagnostic assays. The primary source of false positives and negatives in molecular diagnostic testing, PDs amplify the errors that can dramatically minimize the accuracy of the test and lead to inaccurate diagnoses,” informs Egan, before adding that CoPrimers’ specificity exceeds that of existing PCR technologies to better identify and distinguish between viruses, pathogens, cancer, or other attributes in agricultural or medical applications. Deemed as a ‘technical advance’ as it is 2.5 Mn times more effective in reducing amplification errors, CoPrimers’ specificity facilitates the real multiplexing that enables a single test to identify numerous conditions, attributes, or genetic sequences simultaneously. With superior SNP detection, the technology helps identify the presence of beneficial molecular markers belonging to disease-resistant crops and livestock, as well as testing for mutations that indicate the presence of harmful genes.

CoPrimer technology is the ultimate product for flexibility in multiplex PCR for delivering great reductions in costs and turnaround times in the lab, and driving laboratory efficiencies


Egan underscores, “CoPrimers are the ultimate product for flexibility in multiplex PCR for delivering great reductions in costs and turnaround times in the lab, and driving laboratory efficiencies. The fact that we’ve eliminated PDs now enables us to test a lot of different targets concurrently in the same reaction. It also enables us to have the flexibility for assay interchangeability.” While it normally takes a huge lab and hundreds of employees for molecular diagnostic testing design, the company performs the tasks on the same scale with a small team, less equipment, and at a much lower cost.

Co-Diagnostics focuses on infectious diseases while conducting PCR reactions. Having bagged the CE mark for the TB, Zika and Zika/dengue/chikungunya multiplex tests, the organization, powered by this technology, is enabling detection of these pathogens and others without the care seekers having to pay a heavy price for it. Co-Diagnostics has currently partnered with Synbiotics Pvt. Ltd. in India, a subsidiary of Ambalal Sarabhai Enterprises Ltd., in an ambitious bid to offer medical diagnostics to the community at affordable rates. In addition, the company is also working with LGC, a London based medical firm, to help farmers grow crops that are resistant to pests and diseases and consume less water.

Appreciation and value for CoPrimers have taken a more literal form in countries like India, wherein 400 million of the population is infected with tuberculosis. “Our products are available to patients at a much lesser cost, and we can test dozens of people at a time. Our tests are built on an open architecture and can be carried out on machines that already exist in prominent labs throughout the country, eliminating a new capital acquisition to run our tests,” adds Egan. At present, Co-Diagnostics is particularly focused on vector control, identifying the mosquitoes bearing flaviviruses such as Zika, dengue, West Nile fever, and similar infectious diseases. “We are aggressively planning to market vector control in the United States as well as other countries, offering diagnostics at reasonable rates,” concludes Egan.

Top 10 In-Vitro Diagnostic Technology Solution Companies - 2019

Company
Co-Diagnostics

Management
Dwight H. Egan, CEO

Description
Co-Diagnostics leverages the CoPrimer technology in enabling an inner reaction in the PCR tubes, thereby succeeding in eliminating the chances of PD formation in a PCR reaction. Bioengineered by Dr. Brent Satterfield, the owner of Co-Diagnostics, CoPrimer is a single molecule comprising a probe and a primer attached by a Polyethylene Glycol (PEG) Linker. The elimination of PDs has made it possible for Co-Diagnostics to assess multiple processes at the same time, besides focusing on different targets concurrently in the same reaction. Deemed as a ‘technical advance’ as it is 2.5 Mn times more effective in reducing amplification errors, CoPrimers’ specificity facilitates the real multiplexing that enables a single test to identify numerous conditions, attributes, or genetic sequences simultaneously

Co-Diagnostics News

Co-Diagnostics, Inc. Announces Recent Grant Awards

The Company intends to use funds awarded by the Bill & Melinda Gates Foundation toward completion of tuberculosis and HPV tests for its Co-Dx PCR Home™ platform
SALT LAKE CITY - Co-Diagnostics Inc. announced grants awarded by the Bill & Melinda Gates Foundation related to the tuberculosis (TB) and human papillomavirus (HPV) tests on the Company's Co-Dx PCR Home™ platform.
The TB and HPV grants, totaling $1.33 million and $987,000 respectively, will be allocated to support the completion of these tests, aimed at addressing critical needs in priority global markets.
In 2014, the United Nations Member States and the World Health Organization (WHO) made a joint commitment to eradicate the global TB epidemic by 2030. Unfortunately, the progress towards this goal was hampered by the COVID-19 pandemic, which impeded, halted, or reversed advancements in reaching the global TB targets. Shockingly, the WHO estimates that approximately 4.2 million cases of TB went undiagnosed worldwide in 2021, accounting for nearly 40% of the actual cases. This stark reality underscores the urgent requirement for affordable, high-quality, point-of-care TB diagnostics to facilitate prompt treatment decisions for this disease, which holds a mortality rate of approximately 50% if not treated.
According to the National Cancer Institute, high-risk HPVs are responsible for approximately 5% of all cancers globally, with women being affected nearly 10 times more than men. Cervical cancer, specifically, claims an estimated 264,000 lives each year, as reported by the WHO. Alarmingly, over 85% of these deaths occur in low- and middle-income countries, underscoring the need for increased access to diagnostics, vaccinations, and cancer screenings. The WHO believes that such interventions have the potential to significantly reduce these fatalities and make a considerable impact on improving global health outcomes.
"The WHO and UN initiative to end the global TB epidemic is exactly in line with the key functionality of our new Co-Dx PCR Home platform currently in development, and with our stated mission to prevent the spread of infectious diseases by increasing the availability of high-quality PCR diagnostics worldwide," said Dwight Egan, CEO of Co-Diagnostics.
"Despite being a highly treatable disease, TB took the lives of 1.6 million people in 2021, and we believe our new platform will help support the worldwide effort to help prevent the spread of both TB and HPV in countries where they have been endemic killers for generations. This includes India, where we have already created infrastructure and manufacturing capabilities through our joint venture, CoSara Diagnostics. We believe that our new platform has the potential to dramatically improve access to diagnostics and thus reduce healthcare costs by making high quality diagnostics more accessible to the people and places where they are most needed."
The Co-Dx PCR Home and its associated tests are subject to review by the FDA and/or other regulatory bodies and are not yet available for sale.