08/05/2021

LumiraDx Gets Reissued Food and drug administration Crisis Use Authorization for Its Significant Sensitivity, Immediate COVID-19 Molecular Lab Check

LumiraDx SARS-Cov-2 RNA STAR Full employs proprietary qSTAR technology, which types the basis of LumiraDx’s issue of treatment molecular assays. In 2020, the technologies was utilized to start Quickly Lab Answers a dedicated company device to help tackle the COVID-19 tests disaster by growing existing laboratory ability. LumiraDx SARS-Cov-2 RNA STAR Total makes use of a immediate amplification process that combines lysis and amplification in a single phase, detecting SARS-CoV-2 viral nucleic acid in below 20 minutes on typical open up channel PCR systems – a process which commonly will take a lot more than 1 hour.  

“LumiraDx’s innovative qSTAR technology simplifies and accelerates COVID-19 molecular lab screening capacity while protecting large sensitivity of detection,” explained Pooja Pathak, VP Platform Technique. “With the new product or service improvements, RNA STAR Comprehensive reagents deliver superior sensitivity exam outcomes with almost all open up channel PCR programs in the US and help a throughput in a person hour what completely automatic programs supply in a working day. With the EUA authorization, we are performing with our commercial companions to put into practice fast, accurate screening at occasions, universities and workplaces, in support of safe and powerful reopening of society.”

About LumiraDx SARS-CoV-2 RNA STAR Complete 
SARS-CoV-2 RNA STAR Finish obtained an EUA from the Fda on October 14, 2020 and LumiraDx options to finish the approach to acquire CE Mark. The re-issued EUA comprised of enhanced limit of detection and extra PCR technique validations.

Crucial product requirements incorporate:

  • Limit of Detection – 1.8 duplicate/µL
  • Direct Amplification – 20 minutes or significantly less soon after sample processing
  • Licensed for use on the next PCR devices – Roche LightCycler® 480 Instrument II, Used Biosystems® 7500 Quickly Dx Genuine-Time PCR Instrument, Utilized Biosystems QuantStudioTM 5 True-Time PCR Program, Used Biosystems QuantStudioTM 7 Flex Real-Time PCR Procedure, Utilized Biosystems QuantStudioTM 7 Pro True-Time PCR Procedure, Bio-Rad CFX96 ContactTM Program, Agilent AriaMx Real-Time PCR Procedure, or the Agilent Stratagene Mx3005P Actual-Time PCR Method.

EUA Standing of LumiraDx SARS-CoV-2 RNA STAR Total
The LumiraDx SARS-CoV-2 RNA STAR Complete has not been cleared or accredited by the Food and drug administration. The LumiraDx SARS-CoV-2 RNA STAR Total has been authorized by Food and drug administration underneath an EUA only for the detection of nucleic acid from SARS-CoV-2. The test has not been licensed for use to detect any other viruses or pathogens. The exams are authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of unexpected emergency use of in vitro diagnostic tests for detection and/or analysis of COVID-19 beneath Segment 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), until the authorization is terminated or revoked quicker.

About LumiraDx FastLab Methods
LumiraDx Rapid Lab Remedies is a focused LumiraDx business unit that supports significant-complexity laboratory testing by making use of its ground breaking qSTAR nucleic acid amplification know-how in an obtainable substantial-throughput structure to leverage current molecular laboratory operations. Utilizing FastLab Solutions enables laboratories to improve effectiveness and lessen time to result.

About LumiraDx
LumiraDx was founded in 2014 by a team of entrepreneurs: Ron Zwanziger, our Chairman and Chief Government Officer Dave Scott, Ph.D., our Chief Know-how Officer and Jerry McAleer, Ph.D., our Chief Scientist, who have a prosperous keep track of file in setting up and scaling diagnostics companies more than a few decades, such as at providers this kind of as Medisense, Inc., Inverness Professional medical Engineering Inc. and Alere Inc. The firm has lifted around $1 Billion by personal debt and fairness from institutional and strategic traders such as the Bill & Melinda Gates Foundation, Morningside Ventures, U.S. Boston Money Company and Petrichor Healthcare Capital Management. Primarily based in the British isles, with primary R&D and production operations in Stirling, Scotland and San Diego, U.S., and supported by its globally affiliates to give obtain in all main marketplaces, LumiraDx has around 1200 workers globally.

LumiraDx develops, manufactures, and commercializes an ground breaking stage-of-treatment diagnostic Platform. The LumiraDx Platform is developed to deliver lab equivalent diagnostic benefits at the place of care in minutes. It is intended to be inexpensive and accessible for healthcare vendors globally, and to bolster neighborhood-dependent healthcare. 

Even further details on LumiraDx and our SARS-CoV-2 products offerings go to readily available at lumiradx.com

FOR Far more Information and facts Contact
Colleen McMillen
[email protected]

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