ViennaLab Diagnostics GmbH products

BRAF encodes a serine/threonine protein kinase, which plays an important role in signaling pathways involved in cell proliferation and differentiation. Determination of BRAF V600 mutational status is recommended in metastatic colorectal cancer (mCRC) at the same time as RAS mutational status for prognostic assessment (and/or potential selection for clinical trials). Testing of patients with metastatic melanoma or advanced non-small cell lung cancer for BRAF V600 mutations prior to treatment is recommended, as BRAF V600 mutation positive patients may benefit from BRAF inhibitor therapy (e.g. dabrafenib, trametinib, vemurafenib).

NSCLC comprises approximately 85% of all lung cancers. Tumor specimens from patients should be tested for the presence of EGFR mutations prior to TKI treatment. The EGFR XL StripAssay® and EGFR T790M RealFast™ Assay are designed to assist clinicians in the stratification of patients considered for TKI therapy.

A reliable tool to personalize therapy of lung cancer patients with acquired TKI-resistance mutation T790M in the EGFR gene

Alpha-1 Antitrypsin (AAT) deficiency is an inherited disorder, which is still an underappreciated, but treatable cause of chronic obstructive pulmonary disease (COPD). The AAT RealFast™ Assay is designed for the simultaneous detection of protease inhibitor (PI) variants *S and *Z of the SERPINA1 gene, representing the most frequent alleles associated with AAT deficiency.

Congenital adrenal hyperplasia (CAH) is an inherited disorder affecting steroid hormone synthesis. The CAH StripAssay^® detects the most common point mutations, whereas the CAH RealFast™ CNV Assay identifies copy number variations (CNVs) in the CYP21A2 gene in patients with CAH. For comprehensive genetic analysis both assays should be used in combination.

Genetic variants of the drug-metabolizing enzyme CYP2C9 lead to high inter-individual dose response variability of certain drugs, in particular coumarin-based anticoagulants. The CYP2C9 mpx RealFast™ Assay allows for the simultaneous detection of CYP2C9*2 and CYP2C9*3 variants exhibiting impaired enzyme function.

Carbamazepine is an anticonvulsant commonly prescribed for the treatment of epilepsy, bipolar disorder and trigeminal neuralgia, but can also cause severe cutaneous adverse reactions in patients who are positive for variant alleles HLA-A*31:01 or HLA-B*15:02. ViennaLab RealFast™ Assays discriminate between the presence or absence of these alleles and thus are a tool to prevent hypersensitivity reactions.

HLA-B*57:01 is a genetic risk factor for hypersensitivity reactions to abacavir, an antiretroviral drug used in HIV therapy. The HLA-B5701 RealFast™ Assay determines the presence or absence of HLA-B*57:01 alleles in patients.

The IL28B RealFast™ Assay helps to predict the success of antiviral therapy and sustained virologic response (SVR) in Hepatitis C Virus (HCV) infected patients.

Mutations in the methylenetetrahydrofolate reductase (MTHFR) gene are associated with decreased enzyme activity, which leads to hyperhomocysteinemia and toxic side effects of methotrexate therapy. ViennaLab assays identify patients predisposed to develop cardiovascular diseases or intolerance to methotrexate.