Co-Diagnostics to use grants to develop PCR tests

Molecular diagnostics company Co-Diagnostics has announced grants awarded by the Bill & Melinda Gates Foundation will be used to develop tuberculosis (TB) and human papillomavirus (HPV) tests on its Co-Dx PCR Home platform.

The TB and HPV grants in the amounts of $1.33 million and $987,000, respectively, will be applied towards completion of these tests, intended for priority global markets.

In 2014, all United Nations Member States and the World Health Organization (WHO) committed to ending the global TB epidemic by 2030, before the COVID-19 pandemic slowed, stalled or reversed progress of global TB targets. The WHO estimates that roughly 4.2 million cases of TB went unidentified in 2021 worldwide, representing nearly 40% of actual cases, highlighting the need for a dramatic increase of affordable, high-quality, point-of-care TB diagnostics to enable rapid treatment decisions to be made for a disease that has a mortality rate of about 50% if left untreated.

The National Cancer Institute estimates that high-risk HPVs cause roughly 5% of all cancers worldwide, with the rate among women being nearly 10 times higher than that for men and leading to an estimated 264,000 cervical cancer deaths each year according to the WHO. More than 85% of these deaths are in low- and middle-income countries, and all of which the WHO believes can be dramatically reduced by access to diagnostics, vaccinations, and cancer screenings.

"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.


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