Strengthening Diagnostic Precision: New Additions and Updates to the Wieslab Portfolio

At Wieslab Diagnostic Services, we continuously review and refine our portfolio to ensure that our testing services reflect the latest scientific evidence and the evolving needs of clinicians and patients. As our understanding of disease biology advances, so must the diagnostic tools available to support confident clinical decision-making.

With this commitment in mind, we are pleased to introduce four portfolio changes: a new extended analysis panel for Primary Membranous Nephropathy, replacement of pTau181 with pTau217 in Alzheimer's disease testing, a change to our Myasthenia Gravis testing portfolio, and an updated FGFR3 antibody assay methodology. All updates are available from 1 October 2026.

Together, these updates strengthen diagnostic precision and support more confident clinical decision-making across nephrology, neurology, and autoimmune neuropathy testing.

New Primary Membranous Nephropathy (PMN) – Extended Analysis Panel

In PMN, identification of the target antigen is vital for determining potential underlying conditions and directing the correct treatment course for patients. Wieslab’s new Primary Membranous Nephropathy (PMN)- Extended Analysis panel (Panel 589) brings together key antigen-specific assays to support the diagnosis and classification of autoimmune membranous nephropathy.

The curated panel tests for the key PMN antigens and adds the new NELL1, which is also available as an individual test (Test 244). NELL1 is one of the most clinically important antigens in PMN, helping identify a substantial proportion of patients who test negative for the most commonly screened PMN antigens. It is also strongly associated with secondary causes such as malignancy, drug-induced disease, and autoimmune conditions, helping clinicians uncover potential underlying causes that may otherwise go unrecognized.

By consolidating these assays into a dedicated panel, clinicians can access a comprehensive antigen-based assessment that supports accurate diagnosis and better-targeted patient management.

pTau217 Replaces pTau181 in Alzheimer's Disease Testing

pTau is a central biomarker in Alzheimer's disease, reflecting abnormal tau biology that develops early in the disease process and helping distinguish Alzheimer's disease from other causes of cognitive decline. Evidence now shows that different forms of pTau vary significantly in their ability to identify biological Alzheimer's disease.

In line with advances in Alzheimer's disease biomarker research, Wieslab is replacing pTau181 with pTau217 across its Alzheimer's disease testing portfolio. Compared with pTau181, pTau217 more closely reflects the underlying amyloid and tau pathology of Alzheimer's disease, supporting improved diagnostic accuracy and differentiation from other neurodegenerative disorders. It also demonstrates stronger concordance with established PET and CSF testing results, enabling a simple blood test to provide insight that more closely reflects the findings of these invasive and costly diagnostic approaches. 

pTau217 will replace pTau181 both as an individual assay (Test 886) and within the Alzheimer's Disease Biomarkers – Extended Analysis Panel (Panel 557). Clinicians ordering these tests will therefore automatically benefit from the improved diagnostic performance associated with pTau217. This update further enhances the clinical utility of our Alzheimer's testing portfolio, supporting earlier and more confident identification of biological Alzheimer's disease.  

Updated Myasthenia Gravis Testing Portfolio  

Wieslab is aligning our testing portfolio with current clinical recommendations. Our comprehensive Myasthenia Gravis Panel (Panel 543) includes testing of core antibody tests recommended for MG investigation, including AChR, MuSK, LRP4, and Titin antibodies.

Ryanodine Receptor (RyR) antibody testing (Test 839) remains available to support assessment. These markers offer great sensitivity and specificity, helping clinicians distinguish MG subtypes and support differential diagnosis.  

As part of our continuous work to improve the portfolio, the Striated Muscle Antibody test (Test 085) will be discontinued from 1 October 2026.  By focusing on the antibody tests that form the basis of current MG diagnostics, our updated portfolio provides testing solutions aligned with clinical best practice and supporting confident diagnosis.

Updated FGFR3 Antibody Assay Improves Diagnostic Confidence

FGFR3 autoantibodies have emerged in recent years as important biomarkers in sensory neuropathies such as Small Fiber Neuropathy (SFN). New research suggests that FGFR3 autoantibodies may be directly pathogenic, contributing directly to neuronal hypersensitivity and neuropathic pain. As their clinical significance grows, improvements to FGFR3 testing to combat known issues with specificity and reliability are increasingly vital.

To this end, Wieslab has adopted a new standardized FGFR3 testing protocol based on the latest methodological recommendations. This updated method reduces false-positive findings, improves analytical specificity, and enhances comparability between laboratories. Together, these improvements provide greater confidence in positive results and support more reliable identification of patients with clinically relevant FGFR3 autoimmunity, helping inform diagnosis and treatment decisions.

The updated methodology has been implemented across the Wieslab portfolio from 1 October 2026, both as an individual FGFR3 Antibody assay (Test 630) and within Small Fiber Neuropathy (SFN) - (Panel 535). This update ensures clinicians have access to a more robust and clinically relevant tool for evaluating FGFR3-associated sensory neuropathies.

Committed to Clinical Excellence

These updates reflect our ongoing commitment to providing clinically relevant diagnostics supported by the latest scientific evidence. By introducing new biomarkers, expanding antigen-based testing strategies, and implementing improved assay methodologies, we aim to help clinicians make more informed decisions and deliver more personalized patient care.

Additional developments are planned throughout the autumn, including updates to our request forms and a range of educational activities focused on current topics in clinical diagnostics.

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