Audere's HealthPulse@home further supports LumiraDx's mission to broaden access to support variety of testing needs
LumiraDx SARS-CoV-2 RNA STAR Complete. (Credit: LumiraDx)
LumiraDx (Nasdaq: LMDX) today announced a partnership with digital health non-profit Audere, to offer a self-collected COVID-19 nasal specimen collection kit that has been authorized for use with the LumiraDx SARS-CoV-2 RNA STAR Complete assay to process self-collected samples. Audere’s testing solution, HealthPulse@home, closely aligns with LumiraDx’s continual efforts to increase testing access and support a growing number of testing needs.
Laboratories utilizing the SARS-CoV-2 RNA STAR Complete will be able to integrate HealthPulse@home into their systems. Using HealthPulse@home 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. The HealthPulse@home solution is designed for efficiency and simplicity and requires no additional usability studies.
Sanjay Malkani, President, LumiraDx Fast Lab Solutions stated, “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.”
Paul Isabelli, Chief Operating Officer, Audere, stated “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. 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.”
EUA Status of LumiraDx SARS-CoV-2 RNA STAR Complete
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. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.
Source: Company Press Release