Seeing Covid-19 Health Care Marketplace Opportunities? Look First For Regulatory Barriers
Offering OTC tests for determining exposure to Covid-19, the disease caused by the novel coronavirus spreading worldwide, didn't go unnoticed for long in the US because the FDA hasn’t authorized any OTC test.
You may also be interested in...
OTC access to any test to diagnose COVID-19 without supervision by a health care professional isn't on the near-term horizon for potential launches in the US. In addition to diagnostic kits, digital apps available to directly to consumers for COVID-19 testing on their own would face a steep climb to approval.
The combination of Genesis II Church's rejection of FDA's warning, the potential for serious adverse events linked to its chlorine dioxide formulation and its claims the product treats COVID-19 led FDA to seek an injunction to stop sales of the product a week after it warned the group.
Sanofi has teamed up with Silicon Valley's Luminostics to develop a smartphone-based OTC test which can detect the COVID-19 virus.