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InSignia® Technology

Progressive RNA analysis driving insights for Viability, AST, human biomarkers and more!

InSignia® is a highly accurate RNA expression quantification tool, allowing direct comparison between samples regardless of the amount of starting material. Alternate methods normalize RNA back to housekeeping transcripts, all of which are known to vary with cell type and disease state. In contrast, InSignia® measures the number of specific RNA transcripts per gene copy, and can provide insights for key applications spanning Viability, Antibiotic Susceptibility Testing (AST), human biomarkers, and more.

InSignia®
Technology  

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Viability

Assessment

Distinguishing pathogens causing active infections from dead [1]

Rapid antibiotic

susceptibility testing

Determine pathogen susceptibility when exposed to antibiotics [2]

Biomarkers for

disease prognosis

Analyse gene expression "signatures" predictive of human disease [3]

Cellular

processes

Monitor changes to biological pathways under different conditions

Drug

discovery

Analyse the hit rate and molecular effect of a new drug 

Therapy

monitoring

Potential to track a specific patient’s response to treatment*

Viability assessment in pathogens:

InSignia® is a breakthrough technology that differentiates live, active infections from dead organisms or non-viable remnant genetic material [1]. This unique capability addresses a fundamental limitation of molecular diagnostics, where conventional PCR tests can't distinguish between live pathogens that require treatment and dead pathogens that pose no threat [4]. By analyzing the RNA/DNA ratio of detected pathogens, InSignia® provides a superior tool for researching active infections, with future applications informing on pathogen viability for diagnostics, test of cure verification, and clinical trial monitoring.*

Rapid antibiotic susceptibility testing: 

Expanding on viability assessment, InSignia® can also monitor marker-agnostic pathogen responses under antibiotic stress. This progressive approach to AST combines the speed of molecular testing with the functional proof of phenotypic testing. Since transcriptional changes occur almost immediately following exposure, InSignia® can use this change for AST without the need for time-consuming and less sensitive culture methods. A recent study has shown that by performing short, temperature-controlled exposures directly on clinical samples, this method can inform on pathogen susceptibility profiles without requiring prior knowledge of specific genetic markers [5].

Innovative RNA/DNA analysis distinguishes live pathogens from dead

Imagine the possibilities! With an eye on fighting antimicrobial resistance, InSignia® may guide future decisions for antibiotic use – is it required, and if so, what will be effective?*

Current Tests Can't Tell You What Matters Most

Standard PCR detects pathogen DNA and/or RNA—but they can't distinguish between live, replicating organisms that require treatment, and dead organisms that pose no threat [4].

This creates clinical uncertainty:

  • At diagnosis:
    Is the detected pathogen an active infection requiring treatment?

  • During treatment:
    Is the therapy working to eliminate the infection?

  • Post-treatment:
    Has the infection been cured or are viable pathogens still present?

  • In clinical trials:
    Is the candidate therapeutic impacting disease? 

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InSignia® has the ability to change everything by measuring RNA:DNA ratios to determine viability.

Are you interested in exploring viability applications for research? 
Want to go one step further? - Partner with us to generate clinical evidence using InSignia® technology and gain an edge in the market. 

 

  • Differentiate active infection from treatment-resistant organisms

  • Verify test of cure with confidence

  • Improve clinical trial endpoints

  • Reduce unnecessary antibiotic treatment

Statistics

2-in-1
EFFICIENCY

Combining NAAT sensitivity and culture output in a single one-well molecular test

2 HOURS
Speed

Time-to-result for viability determination vs. days or weeks for culture methods

+/- $0
Cost Neutral

No additional cost per test comparative to commercially available NAAT

Whether you want to conduct infectious disease research, understand complex patient cases, monitor clinical trial outcomes, or plan to deploy viability testing or AST in routine diagnostics, partner with us on an InSignia® project that’ll make a difference!

Contact the Technology team?

SpeeDx offers the technology, expertise, and partnership models to accelerate your diagnostic success.

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*SpeeDx is a global company, operating in compliance with privacy regulations or laws, including, but not limited to; General Data Protection Regulation (EU), HIPAA (USA) and Australian Privacy Law (AU).

Footnote:

*Further validation and regulatory approval would be required

References:

1. Lima, N.E., Strojny, K.L., Nguyen, L.H., Lowes, H., Gibbs, C., Prasad, V., Lonergan, T., Huston, W. and Todd, A. (2024). InSignia®: A molecular viability test for Chlamydia trachomatis and Neisseria gonorrhoeae. In SEXUALLY TRANSMITTED DISEASES (Vol. 51, No. 1, pp. S40-S41).

2. Lima, N., Gibbs, C., Huston, W. & Todd, A. (2019). P070 Determination of antibiotic susceptibility and efficacy by VITA-PCR. Sexually Transmitted Infections, 95(Suppl 1), A106.1-A106.

3. Pelaia, T.M., Kim, K., Lima, N., Gibbs, C., Smith, L.M., Teoh, S., Wang, Y., Denver, C., Mokany, E., Todd, A., Orde, S., Tang, B., McLean, A. & Shojaei, M. (2025). Evaluating the InSignia® IFI27 expression assay for detecting viral respiratory infection compared to a traditional gene normalisation assay. Sci Rep 15, 21481. https://doi.org/10.1038/s41598-025-04688-9

4. Wong, A., Lima, N., Applegate, T. L., Guy, R., Huston, W.M., Hocking, J.S. & Boettiger, D. (2024). Viability of Chlamydia trachomatis in Different Anatomical Sites—a Systematic Review and Meta-analysis, Clinical Infectious Diseases, 2024;, ciae401, https://doi.org/10.1093/cid/ciae401

5. Lima, N. et. al., Manuscript in preparation.

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