The Helix Laboratory

The Helix Laboratory is a high-complexity, CLIA-certified, CAP-accredited facility. Helix’s extraction platform uses reprogrammable Hamilton STAR liquid handling robotics and has full redundancy. Helix is also exploring extraction-free workflows which will enable higher throughput.

Intended Use: Helix COVID-19 NGS Test

The Helix COVID-19 NGS Test is an amplicon based next generation sequencing (NGS) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens (nasopharyngeal swabs, oropharyngeal (throat) swab, mid- turbinate nasal swabs and anterior nasal swabs) from individuals suspected of COVID-19 by their healthcare provider.

Helix COVID-19
NGS Test

Helix's COVID-19 NGS Test is one of the first next-generation sequencing (NGS) tests to receive Emergency Use Authorization from the FDA. The use of NGS technology is a critical part of expanding our nation's testing capacity.

This test is run on the Illumina NovaSeq 6000, enabling high throughput processing of samples while maintaining high sensitivity. With funding from the NIH's RADx program, Helix will be ramping up use of the NGS test to process 100,000 tests a day.

Helix COVID-19 Test

The Helix COVID-19 Test is a real-time RT-PCR test that received Emergency Use Authorization from the FDA in July of 2020. This test is currently being used to support COVID-19 testing for a number of communities, including San Diego County.

Clinical performance studies show a consistent limit of detection (LoD) of 1000 Viral copies / mL.

Intended Use: Helix COVID-19 Test

The SARS-CoV-2 assay is 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.

Contact us to learn more about our COVID-19 resources

Please note: we are not accepting orders from individuals at this time

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Helix's COVID-19 tests

Helix is helping communities and health systems safely navigate through this pandemic by leveraging our state-of-the-art CLIA / CAP lab to provide an end-to-end, highly scalable solution to detect active COVID-19 infections.

Ordering and return of results

Helix is equipped to take orders from healthcare professionals, provide clinical return of results to the ordering professional, and manage reporting to public health agencies. Results available by end of the next day after the sample is received in the lab.

Sample collection

Helix's tests are easy to use (with healthcare provider supervision) and comes with lower nasal swabs, ambient temperature and transport stable media, and a barcoded tube.

High sensitivity and specificity assays

Clinical performance studies show that Helix's test system, including the Helix COVID-19 Test and the Helix COVID-19 NGS test, have both high sensitivity and specificity.
 

Highly automated clinical laboratory

The Helix Laboratory, a CLIA/CAP facility with a demonstrated track record of powering high volume genomic projects, has a high-throughput, automated accessioning process and is scaling to 100,000 tests per day.

An end-to-end COVID-19 test system

Bringing our extensive experience in high volume genomic testing to expand access to sensitive and scalable testing

Fully kitted, including
room temperature and
transport stable media

Easy, self-collected
lower nasal swab with
healthcare professional
(HCP) oversight

Results available
next day after
sample receipt
at Helix's laboratory

Results directly to
patient and ordering
HCP; summary report
available

Helix's COVID-19 test's limitations

The following limitations apply to both the Helix COVID-19 Test and the Helix COVID-19 NGS Test:

  • This test has been authorized by FDA under an EUA for use by the authorized laboratory;
  • This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens;
  • Testing is limited to the Helix Laboratory located at 9875 Towne Centre Drive, San Diego, CA 92121 which is certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets requirements to perform high complexity tests.
  • This test has not been FDA cleared or approved; and
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

COVID-19 Research

As the COVID-19 pandemic continues to unfold, Helix researchers are shifting focus and resources to helping to advance our collective knowledge, including evaluating alternative sample collection approaches and exploring the genetics of COVID-19 pathophysiology.

Modeling the impact of
COVID-19 surveillance testing

In addition to social distancing measures, suppression of SARS-CoV-2 depends on surveillance testing and quarantine of infected individuals to break chains of transmission within a population. Here, we model what impact surveillance testing could have under various conditions.

Saliva testing less sensitive than
NPS in the community

Given Helix’s experience with automated, high throughput processing of saliva samples, Helix investigated the feasibility of saliva as a collection type. Unfortunately, in a prospective study conducted with Renown Health and UCSD, saliva lacked sufficient sensitivity in community populations and Helix is therefore focused on nasal swabs. Helix’s data is consistent with other studies in the community setting, where saliva has lower sensitivity than nasal swabs using RT-PCR.

Genetics of COVID-19 pathophysiology

In an analysis of phenotypic data related to COVID-19 (collected via a recent survey), Helix researchers have found preliminary evidence for a new COVID-19 symptom: Sensitive skin. Respondents who had previously tested positive for COVID-19 reported experiencing sensitive skin much more frequently than people who tested negative (40% vs 7%). This represents an approximately 6-fold enrichment, making it similarly as predictive of COVID-19 as the loss of sense of taste or smell symptom.

GWAS of severe COVID-19 symptoms

plot showing association between genetic variants and COVID-19 severity

Data from the Exome+ assay as well as an ongoing phenotypic survey of research consented participants is contributing to studies done through the Host Genetics Initiative. One recent study leveraged this data to support the finding of an association between a specific gene cluster and COVID-19 severity.

plot showing association between genetic variants and COVID-19 severity
plot showing association between genetic variants and COVID-19 severity