An end-to-end COVID-19 test system

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

Easy self-
collection using
lower nasal swabs.

Choice of unsupervised
or supervised on-site
sample collection.

Authorized for use
in symptomatic and
asymptomatic individuals

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

Results directly
to patient and
ordering HCP

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

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.

Helix does not sell tests to individuals; however, section 3202(b) of the CARES Act of 2020 requires laboratory providers to provide their cash price for the tests on their website. The cash price for the Helix COVID-19 Test is $150.00.

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.

Viral surveillance sequencing program

The Helix® COVID-19 Surveillance Dashboard

Helix and Illumina, with support from the CDC, are collaborating to augment national surveillance infrastructure in the US to track the emergence and prevalence of novel variants of SARS-CoV-2. Sequences are deposited regularly to GISAID and Genbank by the CDC. All B.1.1.7 variants are also reported to relevant public health departments for contact tracing efforts.
 
See dashboard >

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.

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.

Identifying B.1.1.7 in the United States

We first reported the potential spread of the B.1.1.7 variant in the United States based on the occurrence of S gene target failure, or SGTF. Subsequent viral sequence analysis of SGTF samples confirmed that only a subset of these samples harbored all variants that define B.1.1.7. We have continued to sequence SGTF samples and identifying new cases of B.1.1.7 spread in the US. We will continue to regularly sequence high-quality SGTF samples from our lab and place these strains on the SARS-CoV-2 phylogeny.

IFN signaling and the severity of COVID-19

In two studies recently published in Science Magazine, an international team of researchers—including multiple Helix scientists—make a strong case that type 1 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.

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.

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.

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

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.

Predicted COVID-19 positivity based on symptoms

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.

Contact us to learn more about our COVID-19 resources

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

Exciting!

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