LumiraDx Fast Lab Solutions, a LumiraDx business unit, has partnered with digital health non-profit Audere to improve access to Covid-19 tests.
The collaboration will enable LumiraDx to provide a self-collected Covid-19 nasal specimen collection kit authorised for use with its SARS-CoV-2 RNA STAR Complete assay to process self-collected samples.
This will allow laboratories using the SARS-CoV-2 RNA STAR Complete to integrate Audere’s HealthPulse@home Covid-19 specimen collection kit into their systems.
The laboratories can use HealthPulse@home authorised labelling instructions to offer their own self-collection Covid-19 specimen kits to the market.
Recently, Audere received Emergency Use Authorization (EUA) for its HealthPulse@home kit from the US Food and Drug Administration (FDA).
Audere chief operating officer Paul Isabelli said: “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 LumiraDx Fast Lab Solutions network and the clinics and individuals it serves.
“The use of HealthPulse@home 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 assay has received EUA from the FDA for use by authorised laboratories. It is only indicated for detecting nucleic acid from SARS-CoV-2, the disease that causes Covid-19.
LumiraDx Fast Lab Solutions president Sanjay Malkani said: “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.
“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.”
Earlier this year, India granted EUA for LumiraDx’s SARS-CoV-2 Antigen test.