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The foundation of TB Diagnostics

Built on decades of TB immunology leadership, the company’s foundation is a portfolio of peer‑reviewed research and patents that translate host‑response science into practical diagnostics. Pivotal studies from Professor Novel Chegou and Professor Gerhard Walzl identified multi‑analyte blood and CSF biosignatures—such as NCAM, SAP, IL‑1β, sCD40L, IL‑13, ApoA‑1, IP‑10, and CRP—that distinguish active TB from other illnesses and monitor treatment response, with performance validated across African multi‑center cohorts. These insights underpin patented methods for differentiating active versus latent TB using antigen‑stimulated blood, TB meningitis panels using CSF and blood markers, and fingerstick point‑of‑care tests combining CRP with chemokines on multiplex lateral‑flow strips with up‑converting phosphor readers. Together, this IP and evidence base enable low‑infrastructure, rapid triage and confirmatory testing that meet WHO‑aligned use‑cases, forming the scientific and operational core of the company’s products and pipeline

We have patented the biosignature, which identifies the levels of chemicals in the blood of a patient. A biosignature consists of a combination of chemicals and indicates a disease state.


Gerhard Walzl

Patents

Method for diagnosing tuberculosis disease by detecting induced markers after stimulation of T-cells

Method for diagnosing tuberculosis disease by detecting induced markers after stimulation of T-cells

Method for diagnosing tuberculosis disease by detecting induced markers after stimulation of T-cells

This patent describes a blood-based immune test that can tell the difference between active tuberculosis and latent infection by first “waking up” the immune system with TB antigens and then measuring a specific pattern of host biomarkers. After stimulating a patient’s sample with selected Mycobacterium tuberculosis antigens (such as Rv0081, TB18.2, and ESAT‑6/CFP‑10), the test reads out multiple cytokines and proteins (for example, IFN‑γ, IP‑10, IL‑6, CRP, and others) to generate a signature that indicates active disease versus latent TB. The approach improves on traditional tests by focusing on antigen-induced host responses rather than just detecting infection, enabling diagnosis even when sputum is hard to obtain and supporting development of point‑of‑care assays

Biomarkers for diagnosing tuberculous meningitis

Method for diagnosing tuberculosis disease by detecting induced markers after stimulation of T-cells

Method for diagnosing tuberculosis disease by detecting induced markers after stimulation of T-cells

This patent covers lab tests and kits that diagnose TB meningitis by measuring a small panel of biomarkers in cerebrospinal fluid or blood. In CSF, the test looks for myeloperoxidase (MPO) together with immune and vascular markers like IFN‑γ, sICAM‑1, VEGF‑A, and CXCL8 to produce a diagnostic signature for TBM. In blood, it uses a complementary panel—adipsin (complement factor D), Aβ42, and IL‑10—to support diagnosis when lumbar puncture is not possible or to aid triage. The invention also includes device and software implementations to run, interpret, and potentially guide treatment decisions based on these biomarker patterns.

Method for diagnosing tuberculous meningitis

Method for diagnosing tuberculosis disease by detecting induced markers after stimulation of T-cells

Method for diagnosing tuberculous meningitis

This patent outlines a diagnostic test for TB meningitis that measures a small set of immune biomarkers in a patient’s fluid sample to confirm disease. By checking for elevated levels of at least two markers—such as IL‑13, VEGF, LL‑37, IL‑7, IL‑12p70, IFN‑γ, IL‑6, IL‑10, IP‑10, MIP‑1α, MIP‑1β, RANTES, or GM‑CSF—compared with non‑TBM controls, the method provides a clear signature consistent with TBM, enabling earlier, more accurate diagnosis than single‑marker approaches.

Method for diagnosing tuberculosis disease

Marker for the rapid differentiation of active TB disease from latent tuberculosis infection

Method for diagnosing tuberculous meningitis

This patent describes a rapid fingerstick blood test that helps diagnose or rule out TB by measuring C‑reactive protein (CRP) together with one or more immune biomarkers such as SAA, IP‑10 (CXCL10), SAP, I‑309 (CCL1), MIG (CXCL9), or ferritin on a multiplex lateral flow strip. The sample is applied to capture agents on the strip, and signal is detected using advanced readers such as up‑converting phosphor technology to enable sensitive, quantitative results at the point of care. The kit integrates the assay, device, and workflow to deliver quick decisions from a capillary fingerstick, supporting triage and treatment pathways in low‑resource settings.

Biomarkers for diagnosing tuberculosis

Marker for the rapid differentiation of active TB disease from latent tuberculosis infection

Marker for the rapid differentiation of active TB disease from latent tuberculosis infection

This patent presents a blood-based test for TB that measures complement component 4 (CC4) together with at least one partner biomarker—such as CC4b, procalcitonin, CCL1 (I‑309), apolipoprotein‑CIII, RANTES, or TNF‑α—to generate a diagnostic signal for tuberculosis. It also claims an integrated device, kit, and software to run the assay and interpret results, enabling streamlined point‑of‑care use and potential treatment guidance within the same platform.

Marker for the rapid differentiation of active TB disease from latent tuberculosis infection

Marker for the rapid differentiation of active TB disease from latent tuberculosis infection

Marker for the rapid differentiation of active TB disease from latent tuberculosis infection

This patent describes a method that uses a novel set of immune markers—for example, EGF, sCD40L, VEGF, IL-1α, MIP-1β, TGF-α, TNF-α, and IFN-γ—to reliably distinguish between latent TB infection and active TB disease by analyzing blood samples stimulated with TB antigens. By combining results from these biomarkers in specific mathematical models, the test can accurately classify patients with active TB, household contacts, or controls—even in settings where traditional tests lack specificity or sensitivity. The invention includes multiplex kits and assay devices to perform the analysis, dramatically speeding up TB triage and supporting higher diagnostic accuracy than single-marker approaches.

Research

Identification of novel host biomarkers in plasma as candidates for tuberculosis diagnosis and monit

Identification of novel host biomarkers in plasma as candidates for tuberculosis diagnosis and monit

Identification of novel host biomarkers in plasma as candidates for tuberculosis diagnosis and monit

This study reports new blood-based biomarkers capable of distinguishing active TB from other diseases and monitoring how patients respond to TB treatment, aiding more precise care.

Tuberculosis: advances and challenges in development of new diagnostics and biomarkers

Identification of novel host biomarkers in plasma as candidates for tuberculosis diagnosis and monit

Identification of novel host biomarkers in plasma as candidates for tuberculosis diagnosis and monit

This review details recent breakthroughs and ongoing hurdles in TB diagnostic science, especially the discovery and validation of host and pathogen markers in diverse populations.​

Utility of Host Markers Detected in Quantiferon Supernatants for the Diagnosis of Tuberculosis in Ch

Identification of novel host biomarkers in plasma as candidates for tuberculosis diagnosis and monit

Utility of Host Markers Detected in Quantiferon Supernatants for the Diagnosis of Tuberculosis in Ch

The authors validate immune biomarker panels measured in Quantiferon blood test samples to improve TB diagnosis in young children, providing much-needed accuracy for this vulnerable group.

Performance of Two Fingerstick Blood Tests to Triage Adults for Pulmonary Tuberculosis in Community

Performance of Two Fingerstick Blood Tests to Triage Adults for Pulmonary Tuberculosis in Community

Utility of Host Markers Detected in Quantiferon Supernatants for the Diagnosis of Tuberculosis in Ch

This paper evaluates rapid point-of-care TB screening tests based on fingerstick blood, offering options for community and primary care use in resource-limited settings.

Differences in biomarker concentrations in serum and urine of patients with pulmonary tuberculosis a

Performance of Two Fingerstick Blood Tests to Triage Adults for Pulmonary Tuberculosis in Community

Differences in biomarker concentrations in serum and urine of patients with pulmonary tuberculosis a

The research compares multiple diagnostic markers in blood and urine, highlighting practical combinations that can separate TB from other lung diseases like pneumonia.

Clinical Predictors of Pulmonary Tuberculosis Among Patients With Acute and Subacute Lower Respirato

Performance of Two Fingerstick Blood Tests to Triage Adults for Pulmonary Tuberculosis in Community

Differences in biomarker concentrations in serum and urine of patients with pulmonary tuberculosis a

This study examines which clinical and laboratory features best predict pulmonary TB in patients presenting with new or prolonged respiratory symptoms, improving diagnostic algorithms in primary health clinics.

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