Sepsis and inflammatory disorders - global licensing and distribution opportunities

The imiwn sTLR2 RAPID test is a UKCA certified in vitro diagnostic immunochromatographic assay for the semi-quantitative measurement in plasma of human soluble Toll-like receptor 2 (sTLR2) - a biomarker of sepsis and other inflammatory conditions. The level of sTLR2 in plasma has the potential to provide additional information to that of traditional biomarkers such as C-reactive protein (CRP).

The sTLR2 rapid test addresses a significant gap in the sepsis and inflammatory disease diagnostic market, providing scientists and clinicians with a new, potentially transformative tool, and additional opportunities for decision making and health outcomes.

Developed by a UK-based innovative biotech company, with proven technology and a defined roadmap for scalability, the company is positioned for rapid growth through strategic partnerships to reach a broad market, whilst supporting research into additional diagnostic applications and platforms.

Strategic partnering

Find out about licensing and distribution opportunities for our sTLR2 RAPID sepsis and inflammatory disease test, and panel of proprietary monoclonal and polyclonal antibodies.

UK Patent Application GB2502531.3.

Sepsis Market Overview

Soluble Toll-like receptor 2

A soluble form of Toll-like receptor 2 (sTLR2), a receptor of the immune system critically involved in pro-inflammatory responses, is present in human plasma and other bodily fluids and showed anti-inflammatory potential, acting as a decoy receptor to limit inflammation (1-5).

Notably, elevated levels of sTLR2 are present early on in patients with sepsis, and other infective and non-infective inflammatory conditions (1-18), as it has rapid kinetics of release.

Elevated sTLR2 levels can be detected in plasma after just 30 minutes following cell stimulation by bacterial products, reaching peak concentration after just 4 hours, and has a very short half-life. This represents an advantage as an early biomarker over CRP and procalcitonin (PCT), another biomarker of infection. CRP exhibits a slower kinetics of release, as it only begins to rise after 12-24 hours of the insult, peaking within 2-3 days, and PCT becomes elevated after 3-4 hours and peaks about 6-24 hours.

Download Flyer (pdf)
imiwn sTLR2 lateral flow test cassette showing two magenta coloured lines for test and control respectively.

Results in 10 minutes

Semi-quantitative results from a 20µL plasma or serum sample in 10 minutes (whole blood version available from Q3/2025). The human sTLR2 rapid test kit uses proprietary sTLR2 monoclonal antibodies in a simple, convenient lateral flow format. Each kit contains 10 test devices.

Download sTLR2 RAPID Instructions for Use
Lateral flow assay development showing a close up of a dispensor for positive and negative controls.

Quality assured

Developed and manufactured in the UK according to a fully certified medical device quality assurance system (ISO13485).

UKCA Certified.

Find out more

References

1. Soluble forms of Toll-like receptor (TLR)2 capable of modulating TLR2 signaling are present in human plasma and breast milk. LeBouder E. et al. J Immunol. 2003. 171: 6680-6689, and editorial commentary 171: 6321 https://doi.org/10.4049/jimmunol.171.12.6680

2. Soluble TLR2 reduces inflammation without compromising bacterial clearance by disrupting TLR2 triggering. Raby AC. et al. J Immunol. 2009. 183: 506-517.
https://doi.org/10.4049/jimmunol.0802909

3. Toll-Like Receptors 2 and 4 Are Potential Therapeutic Targets in Peritoneal
Dialysis–Associated Fibrosis. Raby AC. et al. J Am Soc Nephrol 2017 Feb;28(2):461-478.
http://dx.doi.org/10.1681/ASN.2015080923

4. Targeting Toll-Like Receptors with Soluble Toll-Like Receptor 2 Prevents Peritoneal Dialysis Solution-Induced Fibrosis. Raby AC. et al. Kidney International, 2018. 94:346-362.http://dx.doi.org/10.1016/j.kint.2018.03.014

5. Therapeutic targeting of chronic kidney disease-associated DAMPs differentially contributing to vascular pathology. Mazzarino M. et al. Front Immunol. 2023 Oct 2;14:1240679. https://doi.org/10.3389%2Ffimmu.2023.1240679

6. Soluble Toll-like receptor 2 is a biomarker for sepsis in critically ill patients with multi-organ failure within 12h of ICU admission. Holst B. et al. Intensive Care Med Exp. 2017 Dec;5(1):2

7. Amniotic fluid soluble Toll-like receptor 2 in pregnancies complicated by preterm prelabor rupture of membranes. Andrys C. et al. J Matern Fetal Neonatal Med. 2013; 26:520–7.

8. The Soluble Form of Toll-Like Receptor 2 Is Elevated in Serum of Multiple Sclerosis Patients: A Novel Potential Disease Biomarker. Hossain MJ et al. Front Immunol. 2018 Mar 14; 9: 457, 2018.

9. Milk matters: soluble Toll-like receptor 2 (sTLR2) in breast milk significantly inhibits HIV-1 infection and inflammation. Henrick BM et al. PLoS One. 2012; 7(7):e40138.

10. Soluble toll-like receptor 2 is significantly elevated in HIV-1 infected breast milk and inhibits HIV-1 induced cellular activation, inflammation and infection. Henrick BM et al. AIDS. 2014;28:2023-32

11. Soluble toll-like receptor 2 in HIV infection: association with disease progression. Heggelund L. et al. AIDS. 2004; 18: 2437-2439.

12. Serum soluble toll-like receptor 2: a novel biomarker for systemic lupus erythematosus
disease activity and lupus-related cardiovascular dysfunction. Houssen ME et al. Int J Rheum Dis. 2016 Jul; 19:685-92. doi: 10.1111/1756-185X.12452. Epub 2014 Aug 14.

13. Characterization of soluble TLR2 and CD14 levels during acute dengue virus infection. Upasani V. et al. Heliyon 9 (2023) e17265

14. Soluble toll-like receptor 2 (TLR-2) is increased in saliva of children with dental caries. Zhao A. et al. BMC Oral Health. 2014; 14:108

15. Membrane and soluble Toll-like receptor 2 in patients with psoriasis treated by Goeckerman therapy. Kondelkova K. et al. Int J Dermatol. 2014; 53(11):e512-7. doi: 10.1111/ijd.12381.

16. Toll-Like Receptor 2 in Serum: a Potential Diagnostic Marker of Prosthetic Joint Infection? Galliera E. et al. J. Clin. Microbiol. 2014; 52: 620-623.

17. The Role of Soluble TLR-2 in the Immunopathogenesis of Gingivitis. BH Al-Ghurabi - International Medical Journal, 2021; Vol. 28, Supplement No. 1, pp. 37 – 39

18. Insights into Soluble Toll-Like Receptor 2 as a Downregulator of Virally Induced Inflammation. Henrick BM et al. Front. Immunol. 2016. 7:291. doi: 10.3389/fimmu.2016.00291