Our StripAssays

StripAssays are based on PCR and are followed by reverse hybridization. The reverse hybridization takes place directly on the StripAssay test strips. The products are detected by streptavidin-alkaline phosphatase. There are up to 48 immobilized probes for wild types and mutated alleles. It takes less than 6 hours from DNA to result. The results are easy and clear to interpret. The reagents are ready-to-use, the kits are CE/IVD labeled, sensitive and affordable. Below is an overview of all our StripAssays.

Cancer

Below are the Cancer StripAssay from ViennaLab shown. Somatic pathogenic variants in EGFR, KRAS, BRAF and NRAS genes can influence cancer therapies. Identifying such pathogenic variants in these genes allows for more specific treatments. Genetic variants of genes involved in drug metabolism (e.g. DPYD) can alter the response to chemotherapy. The impact of specific genetic variants is addressed in current guidelines for the type of cancer in question.

BRAF StripAssay

BRAF gene mutation assessment is indicated in colorectal cancer, advanced non-small-cell lung cancer, melanoma, and thyroid cancer. BRAF StripAssay is an assay for the identification of BRAF p.V600E (c.1799T>A) based on polymerase chain reaction (PCR) and reverse-hybridization.

BRAF 600/601 StripAssay

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). BRAF 600/601 StripAssay is an assay for the identification of 9 BRAF mutations in codons 600 and 601 based on polymerase chain reaction (PCR) and reverse-hybridization.

EGFR XL StripAssay

Mutations in the epidermal growth factor receptor (EGFR) gene are predictive of the response to EGFR tyrosine kinase inhibitors (TKIs). The assays identify 30 EGFR mutations relevant for non-small cell lung cancer (NSCLC) TKI therapy. The EGFR XL StripAssay is an assay for the identification of 30 EGFR mutations in exons 18/19/20/21 based on polymerase chain reaction (PCR) and reverse-hybridization.

FCGR StripAssay

Germline polymorphisms in the Fc gamma receptor (FCGR) gene have been reported to influence antibody-based cancer therapies. The FCGR StripAssay® identifies the variants FCGR2A-H131R and FCGR3A-F158V. An assay for the analysis of Fc gamma receptor (FCGR) polymorphisms based on polymerase chain reaction (PCR) and reverse-hybridization. 

KRAS StripAssay

Monoclonal antibody (mAb) therapies targeting epidermal growth factor receptor (EGFR) are used in metastatic colorectal cancer (mCRC) therapies. KRAS StripAssays® identifies the most relevant genetic variants of KRAS genes interfering with treatment/therapy success. An assay for the identification of 10 KRAS mutations in codons 12 and 13 based on polymerase chain reaction (PCR) and reverse-hybridization.

KRAS-BRAF StripAssay

The KRAS-BRAF StripAssay is an assay for the identification of KRAS and BRAF gene mutations based on polymerase chain reaction (PCR) and reverse-hybridization. It has ultra-sensitive detection of 10 KRAS mutations in codons 12/13 and the BRAF V600E mutation.

KRAS XL StripAssay

Monoclonal antibody (mAb) therapies targeting epidermal growth factor receptor (EGFR) are used in metastatic colorectal cancer (mCRC) therapies. KRAS XL StripAssay® identifies the most relevant genetic variants of KRAS genes interfering with treatment/therapy success. An assay for the identification of 29 KRAS mutations in codons 12/13/59/60/ 61/117/146 based on polymerase chain reaction (PCR) and reverse-hybridization. 

NRAS XL StripAssay

Monoclonal antibody (mAb) therapies targeting epidermal growth factor receptor (EGFR) are used in metastatic colorectal cancer (mCRC) therapies. NRAS StripAssays® identifies the most relevant genetic variants of NRAS genes interfering with treatment/therapy success. An assay for the identification of 22 NRAS mutations in codons 12/13/59/60/ 61/146 based on polymerase chain reaction (PCR) and reverse-hybridization.

PGX-5FU StripAssay

Fluoropyrimidines are widely used for the treatment of various solid tumors. The PGX-5FU StripAssay® identifies the most severe genetic variant in the dihydropyrimidine dehydrogenase (DPYD) gene. An assay for the identification of DPYD allelic variant IVS14+1 G>A with the response to  5-fluorouracil therapy based on polymerase chain reaction (PCR) and reverse-hybridization.

PGX-5FU XL StripAssay

Fluoropyrimidines are widely used for the treatment of various solid tumors. The newly launched PGX-5FU XL StripAssay® covers the four most clinically important variants with therapeutic relevance for fluoropyrimidine treatment as recommended by the European Medicines Agency in April 2020. 

You can read our publication about DPYD 5FU here

PGX-TPMT StripAssay

Thiopurine-based therapeutic drugs may accumulate to toxic levels in patients carrying genetic variants of the drug-metabolizing enzyme TPMT. The PGX-TPMT StripAssay® identifies the most frequent TPMT variants of therapeutic relevance. An assay for the identification of TPMT variants *2, *3A, *3B, and *3C  associated with response to thiopurine therapy based on polymerase chain reaction (PCR) and reverse-hybridization. 

Genetic Disorders

Diagnostic tool for the identification of disorders are caused by aberrations in the genetic makeup of a person.

CAH StripAssay

Congenital adrenal hyperplasia (CAH) is an inherited disorder affecting steroid hormone synthesis. The CAH StripAssay® detects the most common point mutations. An Assay for the identification of eleven CYP21A2 mutations associated with Congenital Adrenal Hyperplasia (CAH) based on polymerase chain reaction (PCR) and reverse-hybridization.

 

CF StripAssay

Cystic Fibrosis (CF) is the most prevalent life-limiting autosomal recessive disorder in the Caucasian population. We offer population-tailored CF StripAssays® including 34 common CFTR mutations and the IVS8 variants 5T/7T/9T. An assay for the identification of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene mutations based on polymerase chain reaction (PCR) and reverse-hybridization.

CF StripAssay GER

Clinical manifestations vary in severity depending on the underlying CFTR mutations, ranging from classical CF to the milder forms of CFTR-related disorders. We offer CF StripAssay® GER including 31 common CFTR mutations. Assay for the identification of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)gene mutations (German variants) based on polymerase chain reaction (PCR) and reverse-hybridization.

CF StripAssay TUR

CF patients typically show decreased pulmonary function accompanied by persistent respiratory infections, pancreatic insufficiency, malnutrition, and male infertility. We offer CF StripAssay® TUR including 24 common CFTR mutations and the IVS8 variants 5T/7T/9T. An assay for the identification of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene mutations (Turkish type) based on polymerase chain reaction (PCR) and reverse-hybridization.

FMF StripAssay

Familial Mediterranean Fever (FMF) is characterized by recurrent episodes of fever accompanied by painful inflammatory events. The FMF StripAssays® identifies the most frequent disease-causing variants in the MEFV gene and risk factors for amyloidosis. An assay for the identification of 12 MEFV gene mutations based on a polymerase chain reaction (PCR) and reverse-hybridization. 

FMF-SAA1 StripAssay

A severe long-term complication is systemic AA amyloidosis, which is characterized by extracellular deposition of proteolytic fragments of serum amyloid A (SAA) ultimately leading to organ damage. The homozygous condition of the SAA isotype SAA1.1 is significantly linked to AA amyloidosis and clinical severity in patients with FMF and rheumatoid arthritis. An assay for the identification of 12 MEFV mutations and SAA1 genotypes 1.1, 1.3, and 1.5. based on polymerase chain reaction (PCR) and reverse-hybridization.

Gaucher Disease StripAssay

Gaucher disease, the most common inherited lysosomal storage disorder, is caused by genetic variants in the GBA gene leading to glucocerebrosidase deficiency. The Gaucher Disease StripAssay® identifies the most frequent mutations and recombinant alleles. An assay for the identification of 8 mutations and two recombinant alleles in the glucocerebrosidase (GBA) gene based on polymerase chain reaction (PCR) and reverse-hybridization.

Haemochromatosis StripAssay A

Hereditary haemochromatosis is one of the most prevalent genetic disorders in the Northern European population. It is characterized by the progressive accumulation of iron in various organs. The Haemonchromatosis StripAssay® A identifies 18 mutations: twelve HFE mutations, four TFR2 mutations and, two FPN1 mutations.

Haemochromatosis StripAssay B

Hereditary haemochromatosis (HH) is an inherited iron overload disorder characterized by excessive absorption and deposition of iron. This assay identifies 3 HFE gene mutations: C282Y, H63D, S65C based on polymerase chain reaction (PCR)
and reverse-hybridization.

α-Globin StripAssay

Thalassemias are characterized by inherited defective hemoglobin synthesis leading to microcytic, hemolytic anemias. The clinical heterogeneity ranges from asymptomatic to very severe forms requiring regular blood transfusions. α-Globin StripAssay® detects common thalassemia-causing genetic variants worldwide. An assay for the identification of 21 common α-globin gene mutations based on polymerase chain reaction
(PCR) and reverse-hybridization. 

β-Globin StripAssay MED

Severe thalassemia is life-limiting and poses a major public health burden in Mediterranean countries, Africa, the Middle East, South-East Asia, and the Indian subcontinent. This is an assay for the identification of 22 mutations covering >90% of β-globin gene mutations (Mediterranean type) based on polymerase chain reaction (PCR) and reverse-hybridization.

β-Globin StripAssay IME

Severe thalassemia is life-limiting and poses a major public health burden in Mediterranean countries, Africa, the Middle East, South-East Asia, and the Indian subcontinent. This is an assay for the identification of 22 mutations covering >90% of β-globin gene mutations (Indian and Middle Eastern type) based on polymerase chain reaction (PCR) and reverse-hybridization.

β-Globin StripAssay SEA

Severe thalassemia is life-limiting and poses a major public health burden in Mediterranean countries, Africa, the Middle East, South-East Asia, and the Indian subcontinent. Genetic analysis is required to confirm the clinical diagnosis and is indispensable for genetic counseling. This is an assay for the identification of 22 mutations covering >90% of β-globin gene mutations (Southeast-Asian type) based on polymerase chain reaction (PCR) and reverse-hybridization.

β-Thal Modifier StripAssay

Mutations in the alpha- and beta-globin genes lead to reduced or abolished globin-chain synthesis or cause structurally abnormal hemoglobin. The β-Thal Modifier StripAssay® identifies co-inherited variants known to ameliorate severity of beta-thalassemia. An Assay for the identification of 5 polymorphisms associated with severity of β-thalassemia based on polymerase chain reaction (PCR) and reverse-hybridization.

Lactose Intolerance StripAssay

Lactose intolerance is a frequent autosomal recessive condition causing diarrhea, nausea, and flatulence. The disease is strongly associated with genetic variants regulating the expression of the lactase (LCT) gene. An assay for the identification of two lactase genes, polymorphisms -13910T>C and -22018A>G, associated with hereditary lactose intolerance based on polymerase chain reaction (PCR) and reverse-hybridization.

Sugar Intolerance StripAssay

Hereditary fructose intolerance is an autosomal recessive disorder caused by variants of the aldolase B (ALDOB) gene. Affected subjects suffer from abdominal pain, vomiting, hypoglycemia, and unless fructose-containing food is strictly avoided may even die from organ damage. The Sugar Intolerance StripAssay identifies two lactase gene polymorphisms and four aldolase B gene mutations associated with hereditary lactose or fructose intolerance based on polymerase chain reaction (PCR) and reverse-hybridization.

Pharmacogenetics

Pharmacogenetic assays that optimize the personalized treatment of the individual patient.

PGX-5FU StripAssay

Fluoropyrimidines are widely used for the treatment of various solid tumors. The PGX-5FU StripAssay® identifies the most severe genetic variant in the dihydropyrimidine dehydrogenase (DPYD) gene. This assay detects DPYD allelic variant IVS14+1 G>A associated with toxicity of 5FU therapy. 

PGX-CYP2C19 StripAssay

Variations in the CYP2C19 gene lead to inappropriate concentrations of drugs or drug metabolites in the body, which may lead to toxicity, risk of adverse drug reactions or impaired drug efficacy. The PGX-CYP2C19 StripAssay® detects genetic variants resulting in reduced or increased activity of the cytochrome P450 isoenzyme CYP2C19. This assay detects CYP2C19 variants *2, *3, *4, *5, *6, *7, *8, and *17. 

PGX-CYP2D6 StripAssay

Differences in the activity of the liver enzyme CYP2D6 contribute to the inter-individual variability in a majority of drug responses. An assay for the identification of CYP2D6 variants *3, *4, and *6 based on polymerase chain reaction (PCR) and reverse-hybridization. 

PGX-HIV StripAssay

Highly active retroviral therapy (HAART) is a very effective treatment for HIV-positive patients. Allelic variants of certain proteins have been associated with successful HAART. The PGX-HIV StripAssay® identifies variants in genes known to be relevant for effective HAART.

PGX-Thrombo StripAssay

Oral anticoagulants like coumarins are commonly prescribed to prevent and treat thromboembolic disorders. Genetic variants have been shown to have a clinical impact on the safety and efficacy of oral anticoagulation dosing. PGX-Thrombo assay identifies the most relevant genetic variants for appropriate coumarin (e.g. warfarin) dosing. This assay tests for CYP2C9 and VKORC1 variants associated with anticoagulant dose requirements (Coumadin®, Marcumar®, Sintrom®)

PGX-TPMT StripAssay

Thiopurine-based therapeutic drugs may accumulate to toxic levels in patients carrying genetic variants of the drug-metabolizing enzyme TPMT. The PGX-TPMT StripAssay® identifies the most frequent TPMT variants of therapeutic relevance. This assay tests TPMT variants *2, *3A, *3B, and *3C associated with response to thiopurine therapy. 

Genetic Predisposition

Reliable assays for risk assessment prior to disease onset and early diagnosis.

Apo E StripAssay

Specific Apolipoprotein E variants have been associated with type III hyperlipoproteinemia (ApoE2), cardiovascular disease, and Alzheimer’s disease (ApoE4). ViennaLab Apo E StripAssay® easily discriminates between the E2, E3, and E4 variants of ApoE. Assay for the identification of apolipoprotein (apo) E isoforms based on polymerase chain reaction (PCR) and reverse-hybridization.

CVD StripAssay

Cardiovascular Diseases (CVD) are often caused by a combination of a genetic predisposition and an unhealthy lifestyle. CVD StripAssay® identifies various combinations of genetic CVD risk factors. This assay tests for 12 genetic variants associated with cardiovascular diseases. 

CVD StripAssay A

Testing for disease-associated genetic variants in conjunction with an adaptation of lifestyle can greatly contribute to decrease an individual’s CVD risk. An assay for the identification of 8 genetic variants predisposing to atherosclerosis based on polymerase chain reaction (PCR) and reverse-hybridization.

CVD StripAssay T

An assay for the identification of mutations associated with cardiovascular disease (CVD) based on polymerase chain reaction (PCR) and reverse-hybridization. It tests for 9 genetic variants predisposing. 

FV StripAssay

An assay for the detection of the factor V gene mutation G1691A (FV Leiden) based on polymerase chain reaction (PCR) and reverse-hybridization.

FV-PTH StripAssay

An assay for the identification of factor V (FV) and prothrombin (PTH) gene mutations based on polymerase chain reaction (PCR) and reverse-hybridization. 

FV-PTH-MTHFR StripAssay

Assay for the identification of factor V (FV), prothrombin (PTH), and MTHFR gene mutations based on polymerase chain reaction (PCR) and reverse-hybridization. For human in vitro diagnostics.

MTHFR StripAssay

An assay for the detection of the MTHFR gene mutation C677T based on polymerase chain reaction (PCR) and reverse-hybridization.

 

PTH StripAssay

An assay for the detection of the prothrombin gene mutation G20210A based on polymerase chain reaction (PCR) and reverse-hybridization.

HLA B27 StripAssay

HLA-B*27 is a genetic risk factor for seronegative spondyloarthropathies, such as ankylosing spondylitis, reactive arthritis, juvenile rheumatoid arthritis, and anterior uveitis. HLA-B27 StripAssay® detects the majority of currently known HLA-B*27 variants except for some rare alleles.

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