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Helix Partners with San Diego County to Make COVID-19 Testing Accessible to the Community

Helix today announced a partnership with San Diego County to make COVID-19 testing accessible across the County to those who need it most.

As part of this important public-private partnership, Helix will be providing San Diego County with up to 2,000 COVID-19 tests per day.

“We’re incredibly proud to partner with San Diego County to expand access to COVID-19 testing at a time of unprecedented need,” said Marc Stapley, Helix President and CEO. “Given our years of experience in collecting and handling biological samples and reporting clinical results at significant scale, we’re uniquely qualified to help our community during this public health crisis.”

“Communities across the country have been struggling to provide access to fast and reliable COVID-19 testing,” said Greg Cox, Chairman of the San Diego County Board of Supervisors. “Through this strategic partnership with Helix, we’ve made a major step forward in meeting the need for COVID-19 testing here in San Diego.”

“It is critical to public health that San Diego have access to reliable and rapid COVID-19 testing,” said Nick Macchione, Director of San Diego County’s Health and Human Services Agency. “We view Helix as a true partner in our fight against COVID-19.”

San Diego County will be using the Helix COVID-19 Test, a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory nasopharyngeal (NP), anterior nares (AN) and oropharyngeal (OP) swab specimens from individuals suspected of COVID-19 by their healthcare provider. Emergency use authorization is pending and Helix is working interactively with the FDA.

The Helix COVID-19 Test is part of Helix’s broader end-to-end test system, which is available nationally to health systems, employers, governments, and other organizations in need of sensitive, scalable, and fully kitted COVID-19 testing solutions. It includes:

  • Full collection kit (non-invasive lower nasal swab, ambient temperature and transport stable media, barcoded tube) which lessens the need for personal protective equipment (PPE) for frontline healthcare professionals
  • RT-qPCR assay with a limit of detection of 1,000 viral copies / mL
  • Processing in Helix’s high-complexity CLIA-certified, CAP-accredited clinical laboratory in San Diego
  • Integration with healthcare professional ordering systems for order processing
  • Return of results to ordering healthcare professional with an option to return to the tested individual directly
  • Next-day turnaround time following sample receipt at the Helix Laboratory in San Diego, CA
  • Reporting to public health agencies

To support further expansion of its testing capabilities and capacity, Helix has also filed an additional EUA for a higher throughput and more sensitive COVID-19 test based on next-generation sequencing technology, which is currently under review by the FDA.

The Helix COVID-19 test has not been FDA cleared or approved. This test has been validated in accordance with the FDA’s Guidance Document (Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency). FDA independent review of this validation and issuance of Emergency Use Authorization (EUA) is pending.

Additional information, including important test information and limitations, is available at helix.com/COVID. Organizations in need of a COVID-19 testing solution can contact Helix here.

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Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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