iAssay and DDTD Tag Team Against COVID-19
For Release
March 8, 2021
iAssay and DDTD Tag Team Against COVID-19
San Diego— March 8, 2021 — iAssay, Inc., and DDTD (Drugs & Diagnostics for Tropical Diseases), a 501(c)(3) nonprofit, have signed a Memorandum of Understanding (MOU). DDTD is a mission-driven organization to develop accurate, affordable, mass-market treatments and diagnostics for low-resourced and under-served organizations. This step enables organizations to provide DDTD’s high performance COVID-19 serology tests along with automatic digitized reads that are transmitted simultaneously and securely using iAssay’s SimpleCloud™ AWS portal to health records. This will satisfy domestic and international compliance mandates as-well as global health goals. In the United States, the Federal and State requirements support public health and epidemiologic surveillance with the Department of Health and Human Services (HHS) requiring that both positive and negative COVID-19 test results be reported to them or a resulting $1,000 fine for the first violation, and $500 fine per day for ongoing violations. iAssay’s SimpleTest™ sends test results automatically, supporting HHS compliance.
Strength Knows Strength
DDTD has developed easy to use, inexpensive diagnostics to detect neglected tropical diseases like river blindness. Drawing from its experience in operating in under-resourced settings, and responding to the pandemic, DDTD has developed a high-quality, low-cost, and easily deployable COVID-19 serology test.
“With vaccines being rolled out, serology tests will become increasingly important to monitor the degree of protection. There is an obvious need for high-quality tests, which we can provide, and those must be coupled with a reliable means to record the results”, shared Dr. Marco Biamonte Ph.D., Founder and CEO of DDTD. “I believe that the need for tracing results is underestimated and will become of paramount importance both domestically and in developing countries. Together with iAssay, our goal is to provide a convenient and comprehensive solution.”
Planning for an FDA EUA
Currently iAssay is planning to perform testing with DDTD’s COVID-19 serology strip to support an FDA Emergency Use Authorization (EUA). Upon Allowance by the FDA, iAssay’s SimpleTest™ “Intended Use” label will include DDTD’s serology test strip, allowing healthcare practitioners to use the pair in their labs.
“Partnering with Marco, DDTD, and their wonderful products is just great!” said Mr. Lonnie W. Adelman, President and CEO of iAssay, Inc. “We are looking forward to bringing their COVID-19 product to market with an objective and connected read.”
US manufacturing and distribution is set to begin as soon as all governmental requirements are met.