Dublin-based medical technology firm LetsGetChecked has been given emergency approval to sell its COVID-19 test kits to US-based customers.
LetsGetChecked develops and creates at-home tests for diseases that then get sent off to a lab for analysis. The firm has seen a lot of success selling kits to test for sexually transmitted diseases and vitamin levels, and most recently has been developing a process for COVID-19 testing.
The firm's at-home COVID-19 test has just been approved by the US FDA for sale to consumers, having been fast-tracked through the long FDA approval process as an "emergency use" case. This allows the FDA to approve medical products quickly during a declared public health emergency, as long as there are no adequate, approved, and available alternatives.
The test kits include a nasal swab, which is sent to a lab where it's analysed with a polymerase chain reaction (PCR) test that will reveal whether any of the virus' genetic material is present in the sample. In order to make the swab safe for transport, it's put into a tube with a solution that deactivates the virus.
The kit will be sold to US consumers for $129, and the lab expects to offer the test to European customers by the beginning of next month too. Results take around 24 hours from when the test arrives at the lab, and the company has labs in the US to test samples from US-based customers.
Source: Irish News