LumiraDx Receives FDA EUA for the LumiraDx SARS-CoV-2 Antigen Test

Summation

  • The tests are authorized in the United States 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 Act, 21 U.
  • Low cost of ownership – The LumiraDx instrument aims to lower the cost per reportable result by offering a variety of low-cost test strips on a single instrument and associated savings including reduced cost of training, maintenance, and supplies.
  • In addition to the antigen test, the LumiraDx SARS-CoV-2 antibody test, for use with the LumiraDx Instrument, will shortly be submitted to the FDA for EUA review.

LumiraDx, the next-generation point of care diagnostic company, announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the LumiraDx SARS-CoV-2 antigen test, which will help meet the global challenge of delivering fast and cost-efficient COVID-19 tests in community care settings.

LumiraDx SARS-CoV-2 antigen test detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application in symptomatic patients. In clinical studies, the LumiraDx SARS-CoV-2 antigen test demonstrated 97.6% positive agreement versus PCR in patients tested within 12 days of the onset of symptoms, making it the fastest, most sensitive antigen point of care test currently commercially available.

“Actionable diagnostic results at the point of care lead to better health outcomes,” said Ron Zwanziger, LumiraDx CEO. “Now that the FDA EUA has been received, we are working with health systems, major retail clinics, and employers to get our Platform to healthcare providers quickly to utilize in their testing programs.”

The company plans to begin shipping COVID-19 antigen tests by the end of the month, expects to produce 2 million tests in September, and will ramp to 10 million tests produced in December.

The LumiraDx Platform simplifies, scales down, and integrates techniques used in laboratory analyzers to provide lab-comparable diagnostic tests on a single point-of-care instrument that can be easily used in community care settings. The platform consists of a small, portable instrument; microfluidic test strip; simple, standardized workflow; and seamless, secure digital connectivity to the cloud and hospital IT systems. It is designed to offer:

  • Lab comparable performance at point of care in minutes – Each test is developed and validated against its respective lab reference standard, which we believe gives healthcare providers the benefit of both lab comparable performance and real-time results.
  • Broad menu of tests on a single instrument – The platform offers an INR (International Normalized Ratio) test for the management of anticoagulation patients in Europe under CE Mark. The company has a pipeline of over 30 assays across cardiovascular, infectious disease, diabetes, and coagulation disorders with the capability to run immunoassay, chemistry, molecular and other technologies, as well as multiple sample types using a single platform and workflow.
  • Low cost of ownership – The LumiraDx instrument aims to lower the cost per reportable result by offering a variety of low-cost test strips on a single instrument and associated savings including reduced cost of training, maintenance, and supplies.
  • High-quality assurance – The Platform performs more than 30 quality checks during its operation, with performance referenced to standard laboratory methods.

LumiraDx COVID-19 Antigen and Antibody Tests on a Single Platform

In addition to the antigen test, the LumiraDx SARS-CoV-2 antibody test, for use with the LumiraDx Instrument, will shortly be submitted to the FDA for EUA review.

LumiraDx EUA for Fast Lab Solution: LumiraDx recently also received a EUA for its molecular lab reagent kit LumiraDx SARS-CoV-2 RNA STAR, a Fast Lab Solution that utilizes LumiraDx’s innovative qSTAR amplification technology in an accessible high-throughput format with open molecular systems to improve efficiency and speed. LumiraDx SARS-CoV-2 RNA STAR reduces the amplification step of the PCR process from approximately one hour down to 12 minutes.

EUA Status of LumiraDx SARS-CoV-2 Ag test and LumiraDx SARS-CoV-2 RNA STAR

The LumiraDx SARS-CoV-2 Ag test and the LumiraDx SARS-CoV-2 RNA STAR have not been cleared or approved by FDA. The LumiraDx SARS-CoV-2 Ag test has been authorized by the FDA under an EUA only for the detection of SARS-CoV-2 nucleocapsid protein. LumiraDx SARS-CoV-2 RNA STAR has been authorized by the FDA under an EUA only for the detection of nucleic acid from SARS-CoV-2. They have not been authorized for use to detect any other viruses or pathogens.

The tests are authorized in the United States 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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