LumiraDx’s SARS-CoV-2 assay will now offer a self-collected COVID-19 nasal specimen collection kit through a new partnership with digital health non-profit Audere.
The LumiraDx SARS-CoV-2 RNA STAR Complete assay when used with Audere’s testing solution, [email protected] provides the process to self-collect samples. Laboratories utilizing the SARS-CoV-2 RNA STAR Complete will be able to integrate [email protected] into their systems.
Audere’s testing solution, [email protected], closely aligns with LumiraDx’s continual efforts to increase testing access and support a growing number of testing needs.
Using [email protected] authorized labeling instructions, labs can provide their own specimen collection kit solution that fits into the lab’s preference of kit registration, accessioning, and flexibility of shipping carriers.
“With the recent FDA EUA Intended Use expansion on the LumiraDx SARS-CoV-2 RNA STAR Complete, we are bringing access to innovative testing solutions right to the community – whether through high sensitivity mobile molecular labs or through the convenience of superior, simple, remote self-collection technologies with Audere,” says Sanjay Malkani, president, LumiraDx Fast Lab Solutions. “By working with Audere, and providing remote collection, we further enable high quality, cost-effective, convenient, and accurate testing that fits into the needs of the clinic and individuals.”
The He[email protected] solution is designed for efficiency and simplicity and requires no additional usability studies.
“We are excited to partner with LumiraDx and further its mission to provide quality and highly accessible testing solutions that fit the needs of the Lumira Dx Fast Lab Solutions network and the clinics and individuals it serves,” says Paul Isabelli, Chief Operating Officer, Audere. “The use of [email protected] in conjunction with LumiraDx SARS-CoV-2 RNA STAR Complete will broaden access to self-testing solutions, allowing individuals to confidently continue on the path to normalcy.”
The LumiraDx SARS-CoV-2 RNA STAR Complete has not been FDA cleared or approved but has been authorized by FDA for emergency use under an EUA for use by authorized laboratories.
The LumiraDX SARS-CoV-2 RNA STAR Complete has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.