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Please note: we are not accepting orders from individuals at this time
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.
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
lower nasal swab with
next day after
at Helix's laboratory
Results directly to
patient and ordering
HCP; summary report
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.
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
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.