COVID-19 testing takes place in the Helix laboratory, imaged here with Helix CEO Marc Stapley, the San Diego Mayor, and the Helix lab director looking in.

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.

Helix scientists process COVID-19 samples in the Helix Laboratory

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.

Table describing the Helix COVID-19 test validation data, stating a limit of detection of just 1,000 viral copies per millileter.

Intended Use: Helix COVID-19 Test

The Helix COVID-19 Test is a real-time RT-PCR 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 who are suspected of COVID-19 by their healthcare provider.
 
In addition, the Helix COVID-19 Test is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in self-collected anterior nasal swab specimens (supervised specimens collected in transport media or unsupervised specimens collected in saline) from any individual, including individuals without symptoms or other reasons to suspect COVID-19 using the Helix Self-Collection Kit when directly ordered and provided by a HCP. See the summary EUA in the resources section below for more information.

Paper face with one highlighted in blue

Asymptomatic screening

Supporting back-to-work and school applications

The Helix COVID-19 Test is now authorized for use in individuals without symptoms or other reasons to suspect COVID-19 – testing of whom is critically important to reopen schools and workplaces safely.

Healthcare worker in full PPE standing outside COVID-19 testing site

Unsupervised collection

Reducing barriers

The Helix COVID-19 Test is indicated for physician ordered self-collection of samples without the need for supervision by a healthcare professional. By eliminating the need for a healthcare professional to oversee collection, organizations will have significantly more flexibility in how they stand-up and operate testing sites and collection centers. This also helps to address shortages in clinical staffing across the country and ensure those resources are directed to where they are needed most.

**By end of the next day after the sample is received

Limitations

The following limitations apply to the Helix COVID-19 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;
  • Specimens that are self-collected will not be tested with an internal control to confirm that the specimen was properly collected. Self-collected specimens from SARS-CoV-2 positive individuals may yield negative results if the specimen was not collected properly; 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.

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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A flexible and scalable solution

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.

Simplified on-site operations

Our recently expanded EUA enables both supervised and unsupervised self-collection on-site—meaning no healthcare professional is required to be on-site—which helps education and employer partners significantly streamline their operations and decrease their collection costs.

High-sensitivity molecular testing

A recent report from the FDA comparing more than 75 other tests demonstrated that the Helix® COVID-19 Test is one of the most sensitive on the market.
 

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.
 

Beyond just testing

Helix is able to support its partners with additional services as needed, including a local and national courier service and insurance billing and reimbursement

An end-to-end COVID-19 test system

An end-to-end, highly scalable solution to detect active COVID-19 infections

COVID-19 test nasal swab entering a blue shaded nose

Easy self-
collection using
lower nasal swabs

COVID-19 collection site represented as a blue shaded tent icon

Choice of unsupervised
or supervised on-site
sample collection

Two cartoon people stand next to each other.

Authorized for use
in symptomatic and
asymptomatic individuals

Blue clock icon representing Helix's quick turn around time for COVID-19 test results

Next-day results
(after receipt in the
Helix laboratory)

Blue Clipboard shown to represent the return of COVID-19 test results

Results directly
to patient and
ordering HCP

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

Line graph showing how frequent COVID-19 testing can help to quell COVID-19 outbreaks

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

Bar graph showing a nearly 30% decrease in sensitivity for saliva testing compared to nasopharyngeal testing

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

Image showing

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.

Interferon signaling and the severity of COVID-19

Schematic describing the molecular connection between interferon signaling and SARS-CoV-2 infection

In two studies recently published in Science Magazine, an international team of researchers—including multiple Helix scientists—make a strong case that type 1 interferons (IFNs) are essential to control SARS-CoV-2; that diminished IFN response is a cause of severe symptoms; and that auto-antibodies to cytokines can lead to immunodeficiencies.

Predicted COVID-19 positivity based on symptoms

Manhattan plot showing two locations in DNA that trend towards significant associations with COVID-19

In this study, researchers in the Netherlands collaborated with Helix researchers to examine symptoms in COVID-19 patients and whether these could be used to predict who among them will test positive for COVID-19. This study validates a previous model and demonstrates how this could be used to in diverse cohorts to expand the power of GWAS studies.

Line graph showing how frequent COVID-19 testing can help to quell COVID-19 outbreaks
Bar graph showing a nearly 30% decrease in sensitivity for saliva testing compared to nasopharyngeal testing
Image showing
plot showing association between genetic variants and COVID-19 severity
Schematic describing the molecular connection between interferon signaling and SARS-CoV-2 infection
Manhattan plot showing two locations in DNA that trend towards significant associations with COVID-19
Line graph showing how frequent COVID-19 testing can help to quell COVID-19 outbreaks
Bar graph showing a nearly 30% decrease in sensitivity for saliva testing compared to nasopharyngeal testing
Image showing
plot showing association between genetic variants and COVID-19 severity
Schematic describing the molecular connection between interferon signaling and SARS-CoV-2 infection
Manhattan plot showing two locations in DNA that trend towards significant associations with COVID-19