Clear Labs Granted EUA by FDA for SARS-CoV-2 Novel Descriptive Diagnostic

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NGS-enabled platform tracks infection clusters for contact tracing and monitors emerging mutations, combining once separate aspects of screening and genomic surveillance

Clear Labs

Clear Labs

At a price comparable to qPCR, Clear Dx™ simultaneously improves test accuracy while providing end-to-end results in hours, instead of days. The sequencing analysis enables monitoring for mutations that may confer drug resistance, enhance virulence, and cause loss of diagnostic targets for PCR.

Clear Labs, providers of the only fully automated and intelligent next-generation sequencing (NGS) in vitro diagnostic (IVD) platform, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Emergency Use Authorization (EUA) for its Clear Dx™ SARS-CoV-2 novel descriptive diagnostic. The system extends available options for labs to scale infectious disease diagnostic testing.

Clear Dx™ offers a fully automated, nanopore-based NGS solution for simultaneous high-volume diagnosis of SARS-CoV-2 and deeper genomic characterization of the virus. At a price comparable to qPCR, Clear Dx™ simultaneously improves test accuracy while providing end-to-end results in hours, instead of days. The sequencing analysis enables monitoring for mutations that may confer drug resistance, enhance virulence, and cause loss of diagnostic targets for PCR. Data from the platform will also help advance emerging pharmaceutical interventions which are intended to target COVID-19.

Clear Labs’ proprietary NGS platform leverages the latest technology in automation, molecular testing, machine learning and a proprietary bioinformatics pipeline. Visualized with intuitive software reporting and data analysis, the flexible architecture has allowed the company to quickly develop a turn-key genomics assay to provide more accurate COVID-19 testing. Based on technology which has revolutionized the food safety testing market, the company’s novel descriptive diagnostic addresses current testing limitations, including high false negative rates and binary results that cannot differentiate RNA viruses and subtypes.

“We’re encouraged by the rapid response of the testing market to stop the global spread of COVID-19, and knew that our technology is serving an unmet need,” said Sasan Amini, CEO of Clear Labs. “The powerful combination of our genomics-based assay and bioinformatics software means that laboratories, hospitals and pharmaceutical companies have access to accurate, up-to-date molecular data that will help them better understand and therefore combat the virus.”

Clear Labs recently received more than $20M incremental funding to continue their expansion in both the food safety and clinical markets. There has been very little innovation in microbiology over the past few decades, so the market is craving new solutions, especially in light of the current COVID-19 pandemic. Clear Labs aims to disrupt the microbiology market with its intelligent next-generation sequencing (NGS) in vitro diagnostic (IVD) platform, and create the “microbiology lab of the future”.

To learn more about Clear Labs and to register interest for Clear Dx™, please visit: https://www.clearlabs.com/covid-19/

Clear Labs’ novel descriptive diagnostic provides clinical diagnostic labs with:

A Superior Diagnostic

  • Accuracy – effectively minimize false positives and false negatives
  • Automation – improve reproducibility, lab efficiency and provide the most assured operator biosafety, while reducing labor and error potential by offering a hands-free workflow
  • Return on Investment – employ the most cost-effective sequencing solution on the market and achieve the highest reimbursement rates
  • Fast Turnaround Time – sample to answer in a single shift, not days
  • Advanced Bioinformatics – fully-automated, scalable computational power and analysis with no informatics resources or system architects required

Highly Granular Virologic Surveillance

  • Epidemiology Empowerment – quickly determine single strain cases due to ongoing community transmission, new variant virus introductions, super-spreader events, and transmission directionality
  • Virus Differentiation – non-binary results assists healthcare professionals to improve treatment outcomes, as well as inform critical public health decisions and action
  • Disease Containment and Spread Mitigation – identify disease clusters, outbreaks and transmission routes, supporting real-time contact tracing
  • Situational Awareness - monitor for mutations that may confer drug resistance, enhance virulence, and cause loss of diagnostic targets for PCR
  • Intervention Aid – track evolution of therapeutic target viral genes

About Clear Labs

Clear Labs is the only automated and intelligent diagnostic NGS platform. We help our customers capitalize on a new era of technology by seamlessly integrating DNA sequencing, bioinformatics, and robotics. The result democratizes genomics within settings never before possible.

With these capabilities, Clear Labs has become a prominent and credible platform for safeguarding the global food supply and enhancing preventative food safety management systems. Now, we are employing our novel genomics platform to drastically improve the quality of testing options within the infectious disease market.

The world’s largest brands and organizations have implemented and are already realizing the advantages of the Clear Labs’ system.

To learn more, please visit: http://www.clearlabs.com/.

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Kat Brown
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