Product Catalog

In vitro diagnostic tests for inherited diseases, genetic

predispositions, pharmacogenetics and oncology
ViennaLab Diagnostics
ViennaLab Diagnostics is an Austrian company with a successful history of more than 25 years
in developing, manufacturing and worldwide distributing genetic tests.

StripAssays® based on PCR followed by reverse hybridization have up to 48 immobilized

probes for wild type and mutated alleles, and are easy to use.

RealFast™ Assays based on real-time PCR detect single nucleotide polymorphisms (SNPs)
and copy number variations (CNVs) fast and simply.

We offer

Tests for Cardiovascular Diseases (CVD), Thalassemia, Familial Mediterranean Fever (FMF),
Haemochromatosis, Gaucher Disease, Alzheimer Disease, Sugar (Lactose, Fructose)
Intolerance, Congenital Adrenal Hyperplasia (CAH), Cystic Fibrosis (CF), KRAS, BRAF, among
others. Products of the pharmacogenetics and oncology portfolio help to achieve safer and
more individualized anticoagulant and cancer therapies.

Quality Management System

All ViennaLab products are designed and manufactured according to the quality standards
of ISO 13485 and are CE/IVD marked where indicated. The tests are also used in many
international research studies and quality assessment schemes, which allow scientific
evidence of the quality employed.
Platform Attributes
StripAssay® RealFastTM Assay
• Simplicity Simple and straightforward protocols Fast and easy handling

• Efficiency Manual or automated Same protocol for all genotyping assays

• Speed Less than 6 hours from DNA to result Less than 90 min from DNA to result

• Reliability Easy and clear interpretation of results Controls for wild type and mutant genotypes included

• Flexibility Additional mutations readily integrated Compatible with many real-time PCR instruments

• Convenience Ready-to-use reagents; inexpensive equipment; CE/IVD labeled kits; sensitive and affordable
Sample Preparation Kits
Area Product REF Label Rxn Application
StripAssays® GENXTRACT™
2-014 CE/IVD 100 Rxn DNA extraction from fresh, frozen and dried blood
RealFast™ Assays Blood DNA Extraction System
StripAssays®
Spin Micro DNA Extraction Kit 2-020 RUO 20 Rxn DNA extraction and purification from whole blood and buccal swabs
RealFast™ Assays

RealFast™ Assays D2PCR™ Buffer 2-030 CE/IVD 100 Rxn For direct-to-PCR applications

Liquid Profiling Sample preparation kit for extraction of circulating cell-free DNA (cfDNA) from
Plasma cfDNA Extraction Kit 2-040 RUO 50 Rxn
EGFR T790M up to 4 mL plasma; For use with the EGFR T790M RealFast™ Assay

Workflow of RealFast™ Assays

RealFastTM Assay

Patient sample DNA template Real-time PCR instrument Results

RealFast™ Assays
Single marker detection

Area Product REF Label Application

100 / 32 Rxn
HLA-A3101 Detects the human leukocyte antigen-A (HLA-A) 3101 allele, which is strongly associated with
7-640 / 7-643 CE/IVD
Carbamazepine RealFast™ Assay carbamazepine hypersensitivity reactions in Europeans and Japanese
Hypersensitivity HLA-B1502 Detects the human leukocyte antigen-B (HLA-B) 1502 allele, which is strongly associated with
7-630 / 7-633 CE/IVD
RealFast™ Assay carbamazepine hypersensitivity reactions in Asian populations
Carbohydrate LCT -13910C>T Detects the most common polymorphism in the lactase (LCT) gene causing lactase non-
7-150 / 7-153 CE/IVD
Intolerance RealFast™ Assay persistence
FGB -455G>A Identifies homozygousity for the -455G>A fibrinogen beta-chain (FGB) allele which may
7-230 / 7-233 CE/IVD
RealFast™ Assay increase susceptibility to atherothrombosis in at-risk patients
FV Leiden Detects the most common genetic risk factor associated with venous thromboembolism, the
7-110 / 7-113 CE/IVD
RealFast™ Assay 1691G>A mutation in the Factor V (FV) gene
FXII 46C>T Identifies patients with the unfavorable TT genotype for Factor XII (FXII), who may have an
7-240 / 7-243 CE/IVD
RealFast™ Assay increased susceptibility to thrombotic disorders
FXIII V34L Identifies carriers of the protective 34L variant of Factor XIII (FXIII) among at-risk patients of
7-250 / 7-253 CE/IVD
Cardiovascular RealFast™ Assay hereditary thrombophilia
Diseases (CVD) MTHFR 677C>T
7-160 / 7-163 CE/IVD
RealFast™ Assay Detect common mutations in the methylenetetrahydrofolate reductase (MTHFR) gene causing
MTHFR 1298A>C hyperhomocysteinemia, which is a risk factor for cardiovascular disease
7-170 / 7-173 CE/IVD
RealFast™ Assay
PAI-1 4G/5G Detects the 4G risk allele in the plasminogen activator inhibitor-1 (PAI-1) gene, associated with
7-180 / 7-183 CE/IVD
RealFast™ Assay cardiovascular disease and pregnancy complications
PTH 20210G>A Detects the second most important genetic risk factor for venous thromboembolism in the
7-120 / 7-123 CE/IVD
RealFast™ Assay prothrombin (PTH) gene
Congenital Adrenal CAH Discriminates between deletions, duplications and normal copy number status of the CYP21A2
7-410 / --- CE/IVD
Hyperplasia RealFast™ CNV Assay gene in patients with CAH
­
Genetic HLA-B27 Detects the human leukocyte antigen-B (HLA-B) 27 allele, which is associated with ankylosing
7-620 / 7-623 CE/IVD
Predisposition RealFast™ Assay spondylitis
HFE C282Y
7-130 / 7-133 CE/IVD
RealFast™ Assay
Haemochromatosis Detect common mutations in the HFE gene causing hereditary haemochromatosis (HH) type 1
HFE H63D
7-140 / 7-143 CE/IVD
RealFast™ Assay
RealFast™ Assays
Area Product REF Label Application
100 / 32 Rxn
HLA-B5701 Detects the human leukocyte antigen-B (HLA-B) 5701 allele, which is associated with
7-610 / 7-613 CE/IVD
RealFast™ Assay hypersensitivity to the anti-HIV drug abacavir
IL28B Detects a dinucleotide frame-shift variant coding for interleukin 28B (IL28B) and helps to
7-200 / 7-203 CE/IVD
RealFast™ Assay predict the therapeutic response in Hepatitis C Virus infected patients
Pharmacogenetics
SLCO1B1c.521T>C Detects a variant in human solute carrier organic anion transporter family member 1B1
7-210 / 7-213 CE/IVD
RealFast™ Assay (SLCO1B1) gene in patients who are at higher risk for developing statin-induced myopathy
VKORC1 -1639G>A Detects the most important polymorphism in the Vitamin K Epoxide Reductase Complex 1
7-190 / 7-193 CE/IVD
RealFast™ Assay (VKORC1) gene associated with interindividual dose requirements for oral anticoagulants

Multiplex testing - save costs and sample material

FV-PTH mpx Simultaneous detection of the most important thrombophilic mutations 1691G>A in the
7-115 / 7-118 CE/IVD
Cardiovascular RealFast™ Assay Factor V gene and 20210G>A in the prothrombin gene
Diseases (CVD) MTHFR mpx Simultaneous detection of the most common two mutations in the MTHFR gene: 677C>T and
7-165 / 7-168 CE/IVD
RealFast™ Assay 1298A>C
AAT deficiency/ AAT mpx Detects *S and *Z variants of the SERPINA1 gene predisposing individuals to chronic obstructive
7-265 / 7-268 CE/IVD
COPD RealFast™ Assay pulmonary disease (COPD) and liver disease due to deficiency of alpha-1 antitrypsin (AAT)
HFE mpx
Haemochromatosis 7-135 / 7-138 CE/IVD Simultaneous detection of the two most common mutations in the HFE gene: H63D and C282Y
RealFast™ Assay
CYP2C9 mpx Simultaneous detection of CYP2C9 *2 (c.430C>T) and CYP2C9 *3 (c.1075A>C) polymorphisms
Pharmacogenetics 7-225 / 7-228 CE/IVD
RealFast™ Assay to determine the drug response of known targets, like S-warfarin or phenytoin
RealFast™
Service CS-045 --- Service to assist in establishing RealFast™ Assays as well as for performance monitoring
Confirmation Service

Liquid Profiling
EGFR T790M Detects the T790M mutation in the EGFR gene in cell-free DNA. For monitoring of lung cancer
Oncology 8-110 / 8-113 CE/IVD
RealFast™ Assay patients who undergo treatment with EGFR tyrosine kinase inhibitors.

The three steps of StripAssays®

1. Amplification: Multiplex PCR. Simultaneous biotin-labelling

2. Hybridization: Directly on the StripAssay® teststrips
3. Identification: Labeled products detected by streptavidin-alkaline phosphatase

StripAssays®
Area Product REF Label Tests Application
Alzheimer Disease Apo E StripAssay® 4-280 CE/IVD 20 Tests Detection of isoforms Apo E2, E3 and E4
Lactose Intolerance StripAssay ®
4-300 CE/IVD 20 Tests Detection of two lactase gene polymorphisms -13910T>C and -22018A>G
Carbohydrate
Intolerance Detection of two lactase gene polymorphisms and four aldolase B gene
Sugar Intolerance StripAssay® 4-310 CE/IVD 20 Tests
mutations
CVD StripAssay® 4-240 CE/IVD 20 Tests Testing for 12 genetic variants associated with cardiovascular diseases
CVD StripAssay A ®
4-370 CE/IVD 20 Tests Testing for 8 genetic variants predisposing to atherosclerosis
CVD StripAssay T ®
4-360 CE/IVD 20 Tests Testing for 9 genetic variants predisposing to venous thromboembolism

Cardiovascular FV StripAssay ®
4-330 CE/IVD 20 Tests Detection of the Factor V gene mutation R506Q (FV Leiden)
Diseases (CVD) FV-PTH StripAssay ®
4-290 CE/IVD 20 Tests Detection of the Factor V Leiden and prothrombin gene mutations
FV-PTH-MTHFR StripAssay® 4-260 CE/IVD 20 Tests Detection of the Factor V Leiden, prothrombin and MTHFR gene mutations
MTHFR StripAssay® 4-350 CE/IVD 20 Tests Detection of the MTHFR gene mutation 677C>T
PTH StripAssay® 4-340 CE/IVD 20 Tests Detection of the prothrombin gene mutation 20210G>A
StripAssays®
Area Product REF Label Tests Application
Congenital Adrenal
CAH StripAssay® 4-380 CE/IVD 20 Tests Testing for 11 CYP21A2 mutations
Hyperplasia
CF StripAssay® 4-410 CE/IVD 10 Tests Detection of 34 common CFTR mutations and the IVS8 variants 5T/7T/9T
Cystic Fibrosis CF StripAssay GER
®
4-430 CE/IVD 10 Tests Detection of 31 common CFTR mutations
CF StripAssay TUR
®
4-420 CE/IVD 10 Tests Detection of 24 common CFTR mutations and the IVS8 variants 5T/7T/9T
Familial FMF StripAssay ®
4-230 CE/IVD 20 Tests Detection of 12 MEFV gene mutations
Mediterranean
Fever FMF-SAA1 StripAssay® 4-390 CE/IVD 20 Tests Detection of 12 MEFV gene mutations and SAA1 genotypes 1.1, 1.3 and 1.5
Detection of 8 mutations and two recombinant alleles in the glucocerebrosidase
Gaucher Disease Gaucher Disease StripAssay® 4-250 CE/IVD 20 Tests
(GBA) gene
Genetic
HLA-B27 StripAssay® 4-320 CE/IVD 20 Tests Detection of all disease-relevant HLA-B27 subtypes
Predisposition
Detection of 18 mutations: twelve HFE mutations, four TFR2 mutations and two
Haemochromatosis StripAssay® A 4-220 CE/IVD 20 Tests
Haemochromatosis FPN1 mutations
Haemochromatosis StripAssay® B 4-210 CE/IVD 20 Tests Detection of 3 HFE gene mutations: C282Y, H63D, S65C
BRAF StripAssay ®
5-570 CE/IVD 20 Tests Ultra-sensitive detection of BRAF V600E mutation
BRAF 600/601 StripAssay ®
5-560 CE/IVD 20 Tests Ultra-sensitive detection of 9 BRAF mutations in codons 600 and 601
EGFR XL StripAssay ®
5-630 CE/IVD 20 Tests Ultra-sensitive detection of 30 EGFR mutations in exons 18/19/20/21
Detection of allelic variants of Fc gamma-Receptor 2A (H131R) and 3A (F158V)
FCGR StripAssay® 5-670 RUO 20 Tests
associated with response to lgG antibody therapy
KRAS StripAssay® 5-590 CE/IVD 20 Tests Ultra-sensitive detection of 10 KRAS mutations in codons 12 and 13
Ultra-sensitive detection of 10 KRAS mutations in codons 12/13 and BRAF
KRAS-BRAF StripAssay® 5-580 CE/IVD 20 Tests
V600E mutation
Ultra-sensitive detection of 29 KRAS mutations in codons
KRAS XL StripAssay® 5-680 CE/IVD 20 Tests
12/13/59/60/61/117/146
Pharmacogenetics NRAS XL StripAssay® 5-620 CE/IVD 20 Tests Ultra-sensitive detection of 22 NRAS mutations in codons 12/13/59/60/61/146
(PGX) & Oncology Detection of DPYD genetic variant DPYD*2A associated with toxicity of
PGX-5FU StripAssay® 4-720 CE/IVD 20 Tests
5-fluorouracil therapy
Detection of DPYD genetic variants HapB3, DPYD*13, DPYD*2A, p.D949V
PGX-5FU XL StripAssay® NEW! 4-780 CE/IVD 20 Tests
associated with toxicity of 5-fluorouracil therapy
PGX-CYP2C19 StripAssay® 4-750 CE/IVD 20 Tests Testing for CYP2C19 variants *2, *3, *4, *5, *6, *7, *8 and *17
PGX-CYP2D6 StripAssay ®
4-760 CE/IVD 20 Tests Testing for CYP2D6 variants *3, *4 and *6
Testing for genotypes associated with response to HIV highly active anti-retroviral
PGX-HIV StripAssay® 4-710 CE/IVD 20 Tests
therapy
Testing for CYP2C9 and VKORC1 variants associated with anticoagulant dose
PGX-Thrombo StripAssay® 4-730 CE/IVD 20 Tests
requirements (Coumadin®, Marcumar®, Sintrom®)
Testing for TPMT variants *2, *3A, *3B and *3C associated with response to
PGX-TPMT StripAssay® 4-740 CE/IVD 20 Tests
thiopurine therapy
a-Globin StripAssay® 4-160 CE/IVD 10 Tests Detection of 21 common a-Globin gene mutations
Detection of 22 mutations covering >90% of b-Globin defects found in
b-Globin StripAssay® MED 4-130 CE/IVD 20 Tests
Mediterranean countries
Detection of 22 mutations covering >90% of b-Globin defects found in the
Thalassemia b-Globin StripAssay® IME 4-140 CE/IVD 20 Tests
Middle East and India
Detection of 22 mutations covering >90% of b-Globin defects found in
b-Globin StripAssay® SEA 4-150 CE/IVD 20 Tests
Southeast Asia
b-Thal Modifier StripAssay® 4-170 CE/IVD 20 Tests Testing for 5 polymorphisms associated with severity of b-Thalassemia
Service to assist in establishing StripAssays® as well as for performance
Service StripAssay® Confirmation Service CS-042 --- ---
monitoring

Software
Area Product REF Label Application
StripAssays® StripAssay® Evaluator 6-100 RUO Software for automated scanning of teststrips and interpretation of results
 Distributor:

Manufacturer:
July 2020 • ISO 13485

ViennaLab Diagnostics GmbH

Gaudenzdorfer Guertel 43-45
A-1120 Vienna, Austria t: (+43-1) 8120156-0
www.viennalab.com e: [email protected]

More details available at www.viennalab.com