The FDA letter states that approval is subject only to final review by the FDA of the package inserts for each of the products, a review which has been ongoing, and other standard conditions.
Chembio said that it anticipates final approval in the very near future allowing the company to market its tests to clinical laboratories and hospitals in the United States.
“I am pleased that our development efforts, now fully supported by the FDA review of our clinical data and inspection of our facility, have brought us within clear sight of the goal of approval. Rapid tests allow greater access to testing, which results in more people being diagnosed earlier, when treatment is most effective,” stated Javan Esfandiari, Chembio’s vice president of research & development.