Blog Image - Clear Labs Raises $18M; Plans to Expand Application of Automated Next-Generation Sequencing Platform to COVID-19 Diagnostics

Company’s novel characterizing diagnostic could significantly improve testing rates, results, and ability to trace the virus

In addition to supporting ongoing commercialization of the company’s food safety platform, Clear Safety, the funds will be used to leverage the company’s underlying Next Generation Sequencing (NGS) technology in the clinical market, specifically to enhance the availability and quality of COVID-19 diagnostic tests.

Experts agree that the limitations of COVID-19 testing have been a large contributing factor to the spread of the virus in the United States. Aside from an initial shortage of tests, the existing gold standard diagnostic screening shows 10-30% false negative rates. With such a high rate of false negatives, the other concern is when a symptomatic patient has a negative test result. Symptoms of COVID-19 are often similar in nature to the common cold or flu, making it difficult to decipher if a test result is a false or true negative. Additionally, testing for asymptomatic patients is nearly nonexistent, preventing officials from fully understanding how the virus has spread.

While the lack of ability to track infection clusters and transmission routes presents serious challenges, current mainstream diagnostic tests (including qPCR, and LAMP) are also unable to follow emerging mutations that could create different versions of the virus in the future. This could lead to problematic resistance against new and emerging pharmaceutical interventions intended to target COVID-19.

Clear Labs’ fully- automated NGS platform with its flexible and robust architecture has allowed the company to develop a turn-key genomics-based assay that hasn’t before existed in the clinical space and will provide a new layer of COVID-19 testing never before possible.

“We saw an important opportunity to help stop the global spread of COVID-19 with the platform we’ve developed over the last 6 years. Our technology, while built originally for food safety, has become a powerful genomic tool with unmatched cost, time-to-results, and ease of use that can provide great benefit to the clinical market,” said Sasan Amini “Our genomics-based assay not only provides significantly higher rates of accuracy for detection of SARS-CoV-2, it prepares us for the future of the virus. Clear Labs’ technology will be able to keep up with the rapid evolution of viral RNA so that labs, hospitals and even companies developing therapeutics have up-to-date molecular data to power intervention and large-scale epidemiology.”

Clear Labs’ novel characterizing diagnostic provides hospitals and clinical diagnostic labs with:

Superior Diagnostic:

  • Accuracy – effectively eliminates false positives and significantly minimizes false negatives
  • Automation – improves reproducibility, reduces human labor and potential for error – all while providing the highest possible biosafety for operators
  • Cost Savings – Clear Labs’ platform is the most cost-effective sequencing solution available on the market, and enables the highest reimbursement rates
  • Turnaround Time – end-to-end sample to answer is 8 hours
  • Advanced Bioinformatics – provides automated, cloud-based, scalable computational power with no bioinformaticians required

Powerful Genomic Surveillance:

  • Non-binary Results – our surveillance tool allows labs to differentiate RNA viruses
  • Drive Intervention – monitor evolution of viral genes that are therapeutic targets
  • Empower Large-Scale Epidemiology – identify infection clusters and transmission routes
  • Recognize Co-Infections – identify cases of co-infection
  • No Additional Cost & Time – all genomic surveillance features are included with screening

“Clear Labs previously developed the first and only high quality, rapid and automated pathogen sequencing system, now in regulated commercial use for food safety testing. Based on feedback from leading experts, Clear Labs rapidly developed a SARS-CoV-2 testing system to address the tremendous global need,” said Greg Yap, Partner at Menlo Ventures. “Clear Labs next-gen sequencing, sample-to-answer system has the potential to improve SARS-CoV-2 testing accuracy and availability worldwide”.

Clear Labs’ platform leverages the latest technology in molecular testing, proprietary bioinformatics software, and robotics. It also includes an unprecedented level of automation and robotics to reduce human labor and errors. Clear Labs’ AI and machine learning provide additional insights and trends, allowing researchers, epidemiologists and clinical labs to track infection clusters, drive intervention, and monitor the evolution of viral genes that are therapeutic targets.

“Our team has been working diligently and tirelessly to deploy our technology to help with COVID-19,” said Ramin Khaksar, VP of R&D. “We hope that the power of our platform and what we’ve built will help us all better understand and act on this virus. We’re grateful to everyone who has been on the front lines, and we’re honored to do our part to help.”

Clear Labs is already working with leading hospitals, universities, and labs on deploying the test and expect to receive the FDA Emergency Use Authorization (EUA) within the coming days.

To learn more about Clear Labs and to pre-register for its novel characterizing diagnostic, please visit: http://www.clearlabs.com/covid-19.

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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 leveraging our novel genomics platform for deep COVID-19 characterizing diagnostics.

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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