Dive Brief:

• FDA has authorized LetsGetChecked’s at-home COVID-19 sample collection kit for emergency use in children as young as two years old.

• The emergency use authorization permits guardians to supervise the collection of nasal swab samples by minors aged 12 to 18 years and to assist in the collection of swabs from younger children.

• LetsGetChecked, which disclosed a $150 million financing round last week, secured the EUA after doing a usability study in minors that found no samples needed to be rejected because of incorrect sample collection, packing or insufficient identification information.

Dive Insight:

Virtual care company LetsGetChecked is one of a number of companies betting that the reopening of the economy and increase of in-person interactions involving children will drive demand for COVID-19 sample collection kits designed for use in minors.

Last month, LabCorp secured an EUA to use its Pixel home-collection kit in kids as young as two, and Clinical Enterprise received emergency authorization for its product in children aged three years and up. 

LetsGetChecked received its EUA on the strength of a submission that featured data from usability studies in adults and children aged two to 17 years old. The study in minors tasked 16 adolescents aged 12 to 17 years with collecting their own anterior nasal swab sample under the supervision of an adult. A further 33 adults collected samples from children aged two to 11 years old.

The samples were collected at home under the observation of a study coordinator via video conferencing.

All of the samples from adolescents tested positive for the RNaseP gene, suggesting the swabbing was done correctly. Three of the samples from younger children were rejected because of a delay in processing, but all the swabs that were analyzed tested positive for the RNaseP gene.

Based on the findings, LetsGetChecked updated its home collection instructions and ran another usability study involving 16 adults who collected samples from children aged two to 11 years old. All of the samples arrived at the LetsGetChecked laboratory in an acceptable condition and were found to contain the RNaseP gene.  

LetsGetChecked is selling the kits online for $89. The buyer will receive the test within 24 hours of their purchase and get results 24 to 72 hours after the sample arrives at LetsGetChecked's lab.

The COVID-19 testing service is part of a much broader offering envisaged by LetsGetChecked, which plans to use the proceeds of its recent financing round to build a service that features telehealth, pharmacy capabilities and at-home diagnostics across multiple ailments and chronic conditions.