Audere Receives FDA Emergency Use Authorization for HealthPulse@home COVID-19 Specimen Collection Test Kit

Rhea-AI Summary

Audere has received Emergency Use Authorization (EUA) for HealthPulse@home from the FDA, enabling CLIA-certified laboratories to market their own self-collection COVID-19 specimen kits. This solution reduces costs and time for labs, facilitating quicker market access without individual FDA EUAs. HealthPulse@home allows for at-home or caregiver collection of nasal samples, enhancing testing options amidst ongoing COVID-19 challenges. Audere collaborates with partners like LumiraDx to further expand testing accessibility.

Positive

• Emergency Use Authorization (EUA) granted for HealthPulse@home by the FDA.
• Facilitates CLIA-certified labs to market COVID-19 self-collection kits without individual FDA EUAs.
• Reduces costs and speeds up time-to-market for laboratories.
• Enhances testing accessibility and options through at-home or caregiver collection of specimens.
• Collaboration with LumiraDx to democratize testing further.

Negative

• None.

Enables CLIA-certified laboratories using HealthPulse@home authorized labeling instructions to offer new test kits under Audere's EUA

SEATTLE--(BUSINESS WIRE)-- Audere, a digital health nonprofit developing solutions to improve global health, announced that it has received an Emergency Use Authorization (EUA) for HealthPulse@home from the U.S. Food and Drug Administration (FDA).¹ Using the solution’s authorized labeling instructions, HealthPulse@home seamlessly allows CLIA-certified laboratories to bring their own self-collection COVID-19 specimen kits to market without needing to obtain their own FDA EUA.

HealthPulse@home provides a faster, less expensive, hassle-free option for laboratories looking to offer COVID-19 specimen collection kits in the United States. The HealthPulse@home authorized labeling instructions provide for custom branding, registration, and accessioning processes which require no additional usability studies. Audere also provides recommended vendors and guidance for kit packaging, ordering, and accessioning, helping laboratories quickly bring new tests to market. The solution enables organizations to offer test kits for the unsupervised self-collection or collection by a caregiver of a nasal swab specimen.

“Despite progress made over the past two years, COVID-19 testing remains a pain point in the United States. With breakthrough cases and testing mandates for unvaccinated individuals, there is a continued need for a broad set of accessible testing options. HealthPulse@home aims to eliminate many of the barriers – time, cost, and effort – that currently prevent or delay laboratories from offering their own authorized self-collection kits. Through Audere and its partnerships with organizations like LumiraDx and Previon, we look to further democratize the availability of testing.”
– Paul Isabelli, Chief Operating Officer, Audere

HealthPulse@home enables CLIA-certified laboratories to better serve their communities by offering the convenience of at-home or remote testing. To date, HealthPulse@home has been certified for use with the LumiraDx SARS-CoV-2 RNA STAR Complete test assay.² HealthPulse@home kits must be prescribed by a healthcare provider based on a clinical assessment or recommended by a public health agency. Audere is able to offer an end-to-end testing solution through its preferred partner, Previon. To learn more, visit healthpulsenow.org/test.

News of the HealthPulse@home EUA follows recent announcements from Audere, welcoming Dr. Dino Rech as CEO and participating in an HIV PrEP study with global health partners.

About Audere

Audere is a Seattle-based digital health nonprofit developing solutions to improve global health outcomes in the world’s most underserved communities. Our team of passionate, innovative minds advances health equity by revolutionizing the detection and treatment of diseases, such as malaria, COVID-19, and HIV. Through a deep understanding of key global health needs, Audere combines smartphone technology, computer vision & machine learning, and the best of cloud-based services to deliver tailored healthcare technology solutions worldwide. Development of our projects is funded by grants from the Bill & Melinda Gates Foundation and Justworks. Learn more at auderenow.org.

About LumiraDx

LumiraDx (Nasdaq: LMDX) is a next-generation point of care diagnostics company that is transforming community-based healthcare. Founded in 2014, LumiraDx manufactures and commercializes an innovative diagnostic Platform that supports a broad menu of tests with lab comparable performance at the point of care. LumiraDx diagnostic testing solutions are being deployed by governments and leading healthcare institutions across laboratories, urgent care, physician offices, pharmacies, schools, and workplaces to screen, diagnose, and monitor wellness as well as disease. LumiraDx has, on the market and in development, 30+ tests covering infectious diseases, cardiovascular diseases, diabetes, and coagulation disorders, all on the LumiraDx Platform. In addition, LumiraDx has a comprehensive portfolio of fast, accurate, and cost-efficient COVID-19 testing solutions from the lab to point of need. LumiraDx is based in the UK with more than 1500 employees worldwide. Further information on LumiraDx and the LumiraDx Platform is available at www.lumiradx.com.

About Previon

Previon is the single source for preventive health test kitting, kit logistics, and healthcare communications that provides integrated best-practice solutions through custom health test kits, optimized communications, and value-added consulting to help healthcare organizations adopt processes that close care gaps, meet CMS regulations, and drive continuous quality improvement. Learn more about The Previon Way™ and our innovative Preventive Care as a Service™ (PCaaS™) solution by visiting us at Previon.com and by connecting with us on LinkedIn.

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¹ HealthPulse@home has not been FDA cleared or approved but has been authorized for emergency use by the FDA under an EUA. HealthPulse@home has been authorized only for the collection and maintenance of anterior nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of HealthPulse@home is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices 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.
² 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211207005172/en/

Jennifer Thorson

Marketing, Audere

(425) 835-3801

info@healthpulsenow.org

Source: Audere

FAQ

What does the Emergency Use Authorization for HealthPulse@home involve?

The EUA allows CLIA-certified laboratories to offer self-collection COVID-19 specimen kits using authorized labeling instructions from Audere.

How does HealthPulse@home benefit laboratories?

It enables labs to reduce costs and market self-collection kits faster without needing their own FDA EUA.

What partnerships does Audere have for HealthPulse@home?

Audere collaborates with organizations like LumiraDx and Previon to enhance testing accessibility.

What kind of samples can be collected using HealthPulse@home?

HealthPulse@home allows for self-collection or collection by a caregiver of nasal swab specimens.

Who is the target user for HealthPulse@home kits?

These kits must be prescribed by healthcare providers based on clinical assessments or recommended by public health agencies.