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Devyser BRCA NGS

Next Generation Sequencing Oncology
Reduce hands-on time from days to minutes with Devyser's single tube, next-generation sequencing (NGS) library prep kit for fast and complete characterisation of BRCA1/2.

Discover the advantages of Devyser's NGS workflow

  • Detect all mutations in BRCA1/2
  • One tube per sample means no need for sample splitting
  • Reduce hands-on time from days to under 45 minutes
  • One kit for both germline and somatic mutations
  • Choice of several validated software options, including CNV analysis

NGS has never been easier

The Devyser BRCA kit is easy to implement and highly cost-effective, making it a good match for laboratories of any size. With ready-to-use reagents and a user-friendly workflow, it suites both manual and automated workflows. Devyser's unique single-tube approach simplifies the workflow, reduces hands-on time and minimizes the risk of sample mix-up and contamination. The proprietary multiplex PCR primer chemistry provides full and uniform coverage of BRCA1 and 2, covering all exons and exon/intron junctions. The kit uses overlapping primer design to ascertain superior INDEL coverage and downstream CNV analysis. The Devyser BRCA kit can be used to detect both germline and somatic mutations.

Analytical software options

Laboratories have a choice of fully validated analytical software solutions, locally deployed or cloud-based. We also support integration with other analytical software solutions.

Watch video

 

About BRCA mutation testing

Early identification of germline BRCA mutations can help physicians make informed decisions on risk reduction strategies such as hormone replacement therapy, chemoprevention strategies and prophylactic surgery. Analysis of somatic mutations can help clinicians tailor targeted treatment for ovarian and breast cancer patients.

BRCA NGS

ADDITIONAL NGS LIBRARY KITS

Reduce hands-on time from days to minutes and detect all CFTR mutations in a single tube NGS library prep kit

NGS library clean-up

Specially developed for quick and easy NGS library cleanup with Devyser’s NGS kits

Devyser CFTR NGS

Hereditary Next Generation Sequencing
Reduce hands-on time from days to minutes with Devyser’s single tube, next-generation sequencing (NGS) library prep kit for fast and complete characterisation of the CFTR gene.

Discover the advantages of Devyser's NGS workflow

  • Detect all mutations in the CFTR gene
  • One tube per sample means no need for sample splitting
  • Reduce hands-on time from days to under 45 minutes
  • Direct detection of frequent CNVs
  • Determination of poly-T and TG repeats
  • Choice of several validated software options, including CNV analysis

NGS has never been easier

The Devyser CFTR kit is easy to implement and highly cost-effective, making it a good match for laboratories of any size. With ready-to-use reagents and a user-friendly workflow, it suites both manual and automated workflows. Devyser's unique single-tube approach simplifies the workflow, reduces hands-on time and minimizes the risk of sample mix-up and contamination. The proprietary multiplex PCR primer chemistry provides full and uniform coverage of the CFTR gene. Coverage includes all exons and exon/intron junctions, the promoter region and several clinically relevant deep intronic mutations. Overlapping primer design is used to ascertain superior INDEL and primer site mutation coverage as well as downstream CNV analysis. In addition, the kit also allows analysis of polythymidine variants (5T/7T/9T) along with the upstream TG-repeat region within intron 9 (IVS8).

Analytical software options

Laboratories have a choice of fully validated analytical software solutions, locally deployed or cloud-based. Both include our validated level1 mutation filter based on CFTR2. We also support integration with other analytical software solutions.

Watch video

 

Complete CFTR gene characterization by next generation sequencing

CFTR mutation testing can be used to guide targeted therapies, in newborn screening, CF diagnosis, male infertility caused by CBAVD, and acute recurrent or chronic pancreatitis. More than 2,000 mutations and variants in the CFTR gene have been described. The vast majority of these mutations have a population frequency below 0.1 % with high heterogeneity of mutation distribution between different ethnic groups. Devyser’s CFTR NGS kit enables the detection of all mutations, known and unknown, in a single test.

Devyser CFTR NGS

BRCA NGS testing

Reduce hands-on time from days to minutes and detect all BRCA1 and BRCA2 mutations in a single tube NGS library prep kit

Additional CFTR kits

Rapid allele specific detection of common CFTR mutations using Devyser CFTR Core

Devyser Compact QF-PCR

Capillary Electrophoresis Reproductive
Speed up your routine prenatal aneuploidy analysis with Devyser's market-leading IVD kits using QF-PCR. Devyser Compact enables the analysis of chromosomes 13, 18, 21 and XY in a single PCR mix.

For fast, precise and cost-effective prenatal aneuploidy diagnosis, QF-PCR is the technology of choice. Devyser's market-leading QF-PCR kits bring you these benefits, and more, in a ready-to-use kit. In addition to detecting Down, Edwards, Patau and Klinefelter syndromes, the Devyser Compact kit includes our patented technology for reliable diagnosis of Turner syndrome, using dedicated X-chromosome counting markers. The CE-IVD certified Devyser Compact kit relies on quantitative, multiplex PCR amplification of 26 genetic markers in a single mix for prenatal diagnosis of the most common autosomal and sex chromosome aneuploidies.

Your benefits include

  • Results in less than five hours. The complete procedure from sample to results takes less than five hours, allowing your laboratory to provide results in just one day.
  • Quick and easy implementation. All reagents needed to perform QF-PCR are provided in a single kit.
  • Cost-efficiency. This very simple procedure requires less than 90 minutes hands-on time from sample to results.
  • Fewer re-runs. Devyser’s excellent assay performance and large number of highly informative markers significantly reduce the number of re-runs.
  • No sample mixup. One single mix in PCR and detection reduces the risk of sample mixup.
  • Easy handling. All reagents are ready to use reducing the time needed for PCR set-up and the risk of contamination.
  • Easy results interpretation. GeneMapper and GeneMarker plugins for easy results interpretation and reporting.
  • Reliable detection of Turner syndrome. Two unique X-chromosome counting markers for reliable detection of Turner syndrome are included in Devyser Compact.
Prenatal QF-PCR

More markers

Devyser Complete enables advanced aneuploidy analysis for chromosomes 13, 18, 21 and XY

Improved miscarriage analysis

Eliminate cell culture, increase analysis success rates and speed up your pregnancy loss aneuploidy analysis with Devyser Extend

Devyser Extend QF-PCR

Capillary Electrophoresis Reproductive
Eliminate cell culture, increase analysis success rates and speed up your pregnancy loss aneuploidy analysis for chromosomes 13, 15, 16, 18, 21, 22 and XY using QF-PCR

Pregnancy loss analysis

Women who have undergone one or more spontaneous abortions caused by chromosomal abnormalities are at increased risk for chromosomal abnormalities in future pregnancies. Cytogenetic studies of miscarriages are highly recommended even in the case of the first pregnancy loss. Identification of the possible cause of fetal loss significantly reduces the long-term psychological distress associated with a miscarriage and enables improved genetic counselling in future pregnancies. The most frequently observed numerical chromosomal abnormalities involve chromosomes 13, 15, 16, 18, 21, 22 and X.

Conventional analysis

Conventional cytogenetic studies (karyotyping or FISH) are expensive and need a long period of time in order to obtain results. Moreover, they result in high rates of culture failure, misdiagnosis due to maternal contamination and cell overgrowth as well as insufficient quality of chromosome preparations. Cell culture may selectively yield normal karyotypes or selected abnormal karyotypes that survive in-vitro cell proliferation.

QF-PCR for pregnancy loss analysis

QF-PCR does not require cell culture, requires minute amounts of tissue material and allows the lab to obtain results within one working day. The Devyser Extend v2 kit includes 42 genetic markers for aneuploidy analysis by QF-PCR of chromosomes 13, 15, 16, 18, 21, 22, X and Y. Two unique X-chromosome counting markers for reliable detection of Turner syndrome are also included in Devyser Extend v2.

The Devyser Extend v2 kit is available in two different configurations:

  • Devyser Extend v2 (art. no.: 8-A015.2): For combined detection of chromosomes 13, 15, 16, 18, 21, 22, X and Y
  • Devyser Extend v2 M1 (art. no.: 8-A015.2-M1): For combined detection of chromosomes 15, 16 and 22.
Miscarriage QF-PCR

Thrombophilia mutation analysis

 Devyser Thrombophilia

AZF analysis in male infertility

Devyser AZF v2 and Devyser AZF Extension

Devyser CFTR Core

Capillary Electrophoresis Hereditary
Devyser CFTR Core allows detection of the 36 most frequent CFTR mutations in the European population

Cystic Fibrosis and CFTR

Mutations in the CFTR gene may cause Cystic Fibrosis (CF). One in 25 people of European descent carries a mutated CFTR allele and 1 in 2000–3000 newborns is found to be affected by CF. CFTR mutation testing can be used as an aid in newborn screening, CF diagnosis, and reproductive decisions, allowing clinicians to determine if an abnormal diagnostic result is due to a mutation within the CFTR gene.

Other disorders caused by CFTR dysfunction include male infertility caused by CBAVD and acute recurrent or chronic pancreatitis.

Cystic Fibrosis Molecular Diagnostics

More than 1900 mutations and variants in the CFTR gene have been described. The vast majority of mutations have a population frequency below 0,1 % with high heterogeneity of mutation distribution between different ethnic groups. The Devyser CFTR Core kit has been designed to detect the most common mutations found across populations of European origin.

Devyser CFTR Core

The Devyser CFTR-Core kit is designed to genotype the normal and mutant alleles at 33 loci of the CFTR gene using purified human genomic DNA. Genotype coverage includes a panel of 36 mutations to support genetic diversity of multiethnic European populations. The assay also detects polythymidine variants (5T/7T/9T) within intron 9 (IVS8) of the CFTR gene. In case of a 5T allele, the TG repeat number upstream of the poly-T region can also be determined.

The Devyser CFTR Core kit is based on multiplex allele specific PCR amplification for detection of normal non-mutated (wild-type), and mutated alleles in the CFTR gene. Allele specific PCR amplification generates fluorescently labelled fragments that are analysed by capillary electrophoresis on a Genetic Analyzer instrument. Amplified fragments are identified based on size and fluorescent labels.

 

Detect all CFTR mutations

Reduce hands-on time from days to minutes and detect all CFTR mutations in a single tube NGS library prep kit

REGIONAL CFTR KITS

Rapid allele specific detection of common regional CFTR mutations
Devyser CFTR Italia v2, Devyser CFTR IberiaDevyser CFTR UK

Devyser AZF v2

Capillary Electrophoresis Reproductive
Devyser AZF v2 allows detailed analysis of Y-chromosome microdeletions in the AZFa, AZFb and AZFc regions

Male infertility and Y-chromosome microdeletions

Analysis of the Y chromosome in men with azoospermia or severe oligozoospermia has resulted in the identification of three regions in the euchromatic part of the long arm of the human Y chromosome (Yq11) that are frequently deleted in men with otherwise unexplained spermatogenic failure. PCR analysis of microdeletions in the AZFa, AZFb and AZFc (AZF: Azoospermia Factor) regions of the human Y chromosome is an important screening tool in the work-up of infertile males opting for assisted reproductive techniques. Y chromosome microdeletions are the most common genetic cause of male infertility and screening for these microdeletions in azoospermic or severely oligospermic men is now standard practice in many infertility centers.

AZF deletion testing

Diagnostic testing using the Devyser AZF v2 kit kit relies on PCR amplification of sequence-tagged sites (STS) in the AZFa, AZFb and AZFc regions on the Y-chromosome. Successful amplification of an STS marker indicates presence, whereas absence of PCR amplification is indicative of deletion.

Testing according to EAA and EMQN best practice guidelines

All STS markers and control sequences, recommended by the European Academy of Andrology (EAA) and the European Quality Monitoring Network Group (EMQN) for basic molecular diagnosis of Y-chromosomal microdeletions in the AZFa, AZFb and AZFc regions are included in the kit. If a suspected deletion is detected, extended AZF marker analysis should be made using the Devyser AZF Extension kit. The use of fluorescently labelled primers for all markers allows automated visualization and identification of the STS markers using a Genetic Analyzer. Thus, eliminating multiple PCR reactions, use of toxic chemicals associated with the use of EtBr stained Agarose gels, and the guesswork associated with fragment identification

Y-chromosome microdeletion analysis

Extended AZF analysis

Extended molecular diagnosis of Y-chromosomal microdeletions in the AZF region using Devyser AZF Extension

CBAVD

Detection of CFTR mutations including poly-T and TG variants within intron 9 with Devyser CFTR Core

Devyser AZF Extension

Capillary Electrophoresis Reproductive
Devyser AZF Extension allows extended analysis of Y-chromosome microdeletions in the AZFa, AZFb and AZFc regions

Male infertility and Y-chromosome microdeletions

Analysis of the Y chromosome in men with azoospermia or severe oligozoospermia has resulted in the identification of three regions in the euchromatic part of the long arm of the human Y chromosome (Yq11) that are frequently deleted in men with otherwise unexplained spermatogenic failure. PCR analysis of microdeletions in the AZFa, AZFb and AZFc (AZF: Azoospermia Factor) regions of the human Y chromosome is an important screening tool in the work-up of infertile males opting for assisted reproductive techniques. Y chromosome microdeletions are the most common genetic cause of male infertility and screening for these microdeletions in azoospermic or severely oligospermic men is now standard practice in many infertility centers.

AZF deletion testing

Diagnostic testing using the Devyser AZF Extension kit kit relies on PCR amplification of sequence-tagged sites (STS) in the AZFa, AZFb and AZFc regions on the Y-chromosome. Successful amplification of an STS marker indicates presence, whereas absence of PCR amplification is indicative of deletion.

Testing according to EAA and EMQN best practice guidelines

All STS markers and control sequences, recommended by the European Academy of Andrology (EAA) and the European Quality Monitoring Network Group (EMQN) for extended molecular diagnosis of Y-chromosomal microdeletions in the AZFa, AZFb and AZFc regions are included in the kit. Basic AZF marker screening is performed using the Devyser AZF v2 kit. The use of fluorescently labelled primers for all markers allows automated visualization and identification of the STS markers using a Genetic Analyzer. Thus, eliminating multiple PCR reactions, use of toxic chemicals associated with the use of EtBr stained Agarose gels, and the guesswork associated with fragment identification

CBAVD

Detection of CFTR mutations including poly-T and TG variants within intron 9

Devyser CFTR Core

Basic AZF deletion screening

Basic screening of Y-chromosomal microdeletions in the AZF region

Devyser AZF v2

Devyser Complete QF-PCR

Capillary Electrophoresis Reproductive
Improve your routine prenatal aneuploidy analysis with Devyser's market-leading IVD kits using QF-PCR. Devyser Complete enables fast and advanced aneuploidy analysis for chromosomes 13, 18, 21 and XY

For fast, precise and cost-effective prenatal aneuploidy diagnosis, QF-PCR is the technology of choice. Devyser's market-leading QF-PCR kits bring you these benefits, and more, in a ready-to-use kit. In addition to detecting Down, Edwards, Patau and Klinefelter syndromes, the Devyser Complete kit includes our patented technology for reliable diagnosis of Turner syndrome, using dedicated X-chromosome counting markers. The CE-IVD certified kit relies on quantitative, multiplex PCR amplification of genetic markers for prenatal diagnosis of the most common autosomal and sex chromosome aneuploidies.

Your benefits include

  • Results in less than five hours. The complete procedure from sample to results takes less than five hours, allowing your laboratory to provide results in just one day.
  • Quick and easy implementation. All reagents needed to perform QF-PCR are provided in a single kit.
  • Cost-efficiency. This very simple procedure requires less than 90 minutes hands-on time from sample to results.
  • Fewer re-runs. Devyser’s excellent assay performance and large number of highly informative markers significantly reduce the number of re-runs.
  • No sample mixup. Built-in ID markers enable cross-mix sample identity confirmation.
  • Easy handling. All reagents are ready to use reducing the time needed for PCR set-up and the risk of contamination.
  • Easy results interpretation. GeneMapper and GeneMarker plugins for easy results interpretation and reporting.
  • Reliable detection of Turner syndrome. Two unique X-chromosome counting markers for reliable detection of Turner syndrome are included in Devyser Complete.
Devyser Compact

Single mix QF-PCR

One single PCR mix for rapid prenatal aneuploidy analysis of 26 genetic markers on chromosomes 13, 18, 21 and XY.

Devyser Compact v3

EXTENDED aneuploidy analysis

Rapid prenatal or miscarriage analysis of aneuploidies in chromosomes 13, 15, 16, 18, 21, 22 and XY

Devyser Extend v2

Devyser Thrombophilia

Capillary Electrophoresis Hereditary
The Devyser Thrombophilia assay offers a very simple procedure for testing six relevant mutations implicated in the risk of developing thrombophilia and venous thromboembolism.

Discover the test benefits

  • Identify genetic basis of thrombotic event
  • Aid in therapy selection
  • Treatment optimisation
  • Determine need for prophylaxis
  • Estimate future thrombotic risk

Devyser Thrombophilia

The Devyser Thrombophilia assay offers a very simple procedure for testing the most relevant mutations implicated in the risk of developing thrombophilia and venous thromboembolism (VTE).
It is a multiplex PCR reagent kit for simultaneous detection of six genetic risk factors associated with thrombophilia:

  • Factor V Leiden, G1691A/R506Q. One of the most important genetic risk factors for inherited thrombophilia, found in 20-50% of patients with VTE.
  • Factor V R2, H1299R. Compound heterozygosity for FV R2 and FV Leiden is associated with an increased risk for venous thrombosis compared to that seen in FV Leiden heterozygotes alone.
  • Prothrombin/Factor II, G20210A. Carriers have elevated risk for thrombosis; significantly increased risk in combination with FV Leiden.
  • 5,10-Methylenetetrahydrofolate Reductase (MTHFR), C677T. Homozygosity predisposes to thrombosis in the presence of additional risk factors.
  • MTHFR, A1298C. Compound heterozygosity for MTHFR C677T and MTHFR A1298C is considered a risk factor for cardiovascular disease.
  • Plasminogen Activator Inhibitor 1 (PAI-1/ SERPINE1) 4G/5G. The 4G allele is considered to be a mild risk factor for VTE and Myocardial Infarction.

Thrombophilia

Trombophilia is an abnormality of blood coagulation, leading to increased risk for thrombosis. Thrombophilia can be identified in 50% of people who have an episode of thrombosis that was not provoked by other causes. Venous thrombosis is one of the most common thrombotic disorders affecting up to 2 in 1000 individuals every year and is associated with life-threatening conditions such as pulmonary embolism.

Genetic risk factors for Thrombophilia

The predisposition to form blood clots can arise from mutations, acquired changes in the clotting mechanism or, more commonly, an interaction between genetic and acquired factors. The risk of thrombosis increases with the number of genetic and acquired risk factors present so that individuals with multiple risk factors are at greater risk than those with just a few.

GENETIC RISK FACTORS FOR CVD

Fast detection of genetic risk factors for Cardiovascular disease using Devyser CVD

Rapid miscarriage analysis

Fast detection of aneuploidies in chromosomes 13, 15, 16, 18, 21, 22, X and Y using Devyser Extend

Devyser CFTR Italia v2

Capillary Electrophoresis Hereditary
Devyser CFTR Italia v2 allows detection of 31 CFTR mutations that are frequent in an Italian population

Cystic Fibrosis and CFTR

Mutations in the CFTR gene may cause Cystic Fibrosis (CF). One in 25 people of European descent carries a mutated CFTR allele and 1 in 2000–3000 newborns is found to be affected by CF. CFTR mutation testing can be used as an aid in newborn screening, CF diagnosis, and reproductive decisions, allowing clinicians to determine if an abnormal diagnostic result is due to a mutation within the CFTR gene. Other disorders caused by CFTR dysfunction include male infertility caused by CBAVD and acute recurrent or chronic pancreatitis.

Cystic Fibrosis Molecular Diagnostics

More than 1900 mutations and variants in the CFTR gene have been described. The vast majority of mutations have a population frequency below 0,1 % with high heterogeneity of mutation distribution between different ethnic groups. The Devyser CFTR Italia v2 kit has been designed to detect the 31 most common mutations found in the Italian population in addition to the mutations detected in the Devyser CFTR Core kit.

Devyser CFTR Italia v2

The Devyser CFTR Italia v2 kit is designed to genotype the normal and mutant alleles at 31 loci of the CFTR gene using purified human genomic DNA. Genotype coverage includes a panel of 31 mutations to support the detection of mutations specifically found in the Italian population. The Devyser CFTR Italia v2 also includes the analysis of cross-mix ID markers for sample identity confirmation between the different Devyser CFTR products.

 

DETECT ALL CFTR MUTATIONS

Reduce hands-on time from days to minutes and detect all CFTR mutations in a single tube NGS library prep kit

ADDITIONAL CFTR KITS

Rapid allele specific detection of common CFTR mutations using Devyser CFTR Core

Devyser CFTR UK

Capillary Electrophoresis Hereditary
Devyser CFTR UK allows detection of 17 CFTR mutations that are particularly frequent in the UK population, including common Celtic, Chinese and Pakistani mutations

Cystic Fibrosis and CFTR

Mutations in the CFTR gene may cause Cystic Fibrosis (CF). One in 25 people of European descent carries a mutated CFTR allele and 1 in 2000–3000 newborns is found to be affected by CF. CFTR mutation testing can be used as an aid in newborn screening,CFTR UK CF diagnosis, and reproductive decisions, allowing clinicians to determine if an abnormal diagnostic result is due to a mutation within the CFTR gene.

Cystic Fibrosis Molecular Diagnostics

More than 1900 mutations and variants in the CFTR gene have been described. The vast majority of mutations have a population frequency below 1 % with high heterogeneity of mutation distribution between different ethnic groups. The Devyser CFTR UK kit has been designed to detect the most common mutations found in the UK population in addition to the Devyser CFTR Core kit.

Devyser CFTR UK

The Devyser CFTR UK kit is designed to genotype the normal and mutant alleles at 17 loci of the CFTR gene using purified human genomic DNA. Genotype coverage includes a panel of 17 mutations to support the detection of mutations specifically found in the UK population, including common Celtic, Chinese and Pakistani mutations. The Devyser CFTR UK kit also includes the analysis of cross-mix ID markers for sample identity confirmation compatible with all Devyser CFTR products.

DETECT ALL CFTR MUTATIONS

Reduce hands-on time from days to minutes and detect all CFTR mutations in a single tube NGS library prep kit

ADDITIONAL CFTR KITS

Rapid allele specific detection of common CFTR mutations using Devyser CFTR Core

Devyser CFTR Iberia

Capillary Electrophoresis Hereditary
Devyser CFTR Iberia allows detection of 15 CFTR mutations that are particularly frequent in Spanish and Portuguese populations

Cystic Fibrosis and CFTR

Mutations in the CFTR gene may cause Cystic Fibrosis (CF). One in 25 people of European descent carries a mutated CFTR allele and 1 in 2000–3000 newborns is found to be affected by CF. CFTR mutation testing can be used as an aid in newborn screening, CF diagnosis, and reproductive decisions, allowing clinicians to determine if an abnormal diagnostic result is due to a mutation within the CFTR gene. Other disorders caused by CFTR dysfunction include male infertility caused by CBAVD and acute recurrent or chronic pancreatitis.

Cystic Fibrosis Molecular Diagnostics

More than 1900 mutations and variants in the CFTR gene have been described. The vast majority of mutations have a population frequency below 0,1 % with high heterogeneity of mutation distribution between different ethnic groups. The Devyser CFTR Iberia kit has been designed to detect the most common mutations found in Spanish and Portuguese populations in addition to the mutations covered by the Devyser CFTR Core kit.

Devyser CFTR Iberia

The Devyser CFTR Iberia kit is designed to genotype the normal and mutant alleles at 15 loci of the CFTR gene using purified human genomic DNA. Genotype coverage includes a panel of 15 mutations to support the detection of mutations specifically found in Spanish and Portuguese populations. The Devyser CFTR Iberia kit also includes the analysis of cross-mix ID markers for sample identity confirmation compatible with all Devyser CFTR products.

 

DETECT ALL CFTR MUTATIONS

Reduce hands-on time from days to minutes and detect all CFTR mutations in a single tube NGS library prep kit

ADDITIONAL CFTR KITS

Rapid allele specific detection of common CFTR mutations using Devyser CFTR Core

Devyser HFE

Capillary Electrophoresis Hereditary
For fast and specific detection of mutations in the HFE gene

Key benefits

  • Multiplex detection of relevant HFE mutations and corresponding wild-types
  • Single tube PCR minimizes hands-on time
  • Streamlined protocol to fit workflow with other Devyser assays
  • Single tube PCR reduces analysis time
  • Single tube PCR minimises risk of sample mix up

Devyser HFE is a multiplex PCR reagent kit for simultaneous detection of the three most common mutations, and corresponding wildtypes, in the HFE gene.

Hereditary hemochromatosis

Hereditary hemochromatosis (HH) is a common autosomal recessive disorder of iron metabolism resulting in progressive accumulation of iron. Excess iron is deposited in a variety of organs leading to irreversible tissue damage,particularly in the liver and pancreas. The symptoms include liver cirrhosis, cardiomyopathy, hepatomas, diabetes, arthritis and hypogonadotropic hypogonadism. Classic, or type 1 HH, is caused by mutation in the HFE gene on chromosome 6p21.3. More than 80% of HH patients carry homozygous C282Y mutation. In addition, an increased risk of developing HH has also been shown in individuals where the compound heterozygosity C282Y/H63D is present. The findings are similar for individuals that are compound heterozygous for S65C and C282Y.

Diagnosis and treatment

Confirmatory diagnostic testing to diagnose or rule out HH should be carried out for symptomatic individuals with biochemical evidence of iron overload. Early diagnosis is crucial since severe effects of the disease may occur if the condition is left untreated. Removal of excess iron by therapeutic phlebotomy decreases morbidity and mortality if instituted early in the course of the disease.

Indications for Devyser HFE

  • Patients with HH
  • Patients with early HH symptoms
  • Identification of carriers in affected families
  • Differential diagnosis in chronic viral hepatitis or alcohol-induced liver damage

Devyser UPD-15

Capillary Electrophoresis Reproductive
For assessment of uniparental disomy (UPD), tracing the inheritance of chromosome 15

Key benefits

  • Nine (9) tetra-repeat STR markers for tracing the transmission of chromosome 15
  • Control STR markers on separate chromosomes facilitate exclusion of maternal cell contamination
  • Control STR markers allow built-in sample identification of the proband, maternal and paternal samples
  • Cost-effective solution with less hands-on time required

Uniparental disomy (UPD)

Uniparental disomy (UPD) occurs when a person receives two copies of a chromosome, or part of a chromosome, from oned1 parent and no copies from the other parent. Maternal and paternal UPD-15 represent the most frequently observed UPDs. Patients with maternal UPD-15 suffer from Prader-Willi syndrome (PWS) whereas patients with paternal UPD-15 suffer from Angelman syndrome (AS). Chromosome 15 UPD testing is relevant in various prenatal diagnostic conditions including apparent confined placental mosaicism, homologous and non-homologous Robertsonian translocations and as genomic biomarker for detecting chromosome origin. The assessment of UPD is performed using informative STR markers to trace the transmission of chromosome 15 from each parent to the child in order to determine whether the child demonstrates normal biparental inheritance, or uniparental inheritance. UPD analysis requires samples from the child/proband and both parents. All cases positive for UPD should be confirmed for stipulated paternity.

The Devyser UPD-15 diagnostic kit

Devyser UPD-15 relies on amplification of tetra nucleotide STR markers in order to minimize formation of stutter bands and thereby simplifying results interpretation. Reducing stutter is especially important when two alleles from the individuals investigated are close in size. Devyser UPD-15 also includes STR markers on chromosomes 13 and 18 to facilitate the exclusion of maternal contamination by absence of non-inherited maternal alleles in the proband sample. Moreover, detection of maternally and paternally inherited fetal alleles from chromosomes 13 and 18 allows built-in sample identification of the proband, maternal and paternal samples. Four out of nine STR markers that are specific for chromosome 15 are located within the 15q11-13 deletion region.

Devyser Resolution 21 v2

Capillary Electrophoresis Reproductive
Rapid protocol for advanced reflex or resolution aneuploidy testing of chromosome 21 using QF-PCR analysis.

Devyser Resolution 21 v2 is a QF-PCR kit for extended aneuploidy analysis of chromosome 21. The kit enables advanced marker resolution capabilities by combining STR markers used in the Devyser Complete v2 and Devyser Compact v3 kits with additional markers for reflex testing or for extended chromosome specific analyses. The kit allows analysis of totally nine (9) STR markers on chromosome 21 for reflex testing or for other chromosome specific analyses requested.

SINGLE MIX QF-PCR

One single PCR mix for rapid prenatal aneuploidy analysis of 26 genetic markers on chromosomes 13, 18, 21 and XY.

Devyser Compact v3

EXTENDED ANEUPLOIDY ANALYSIS

Rapid prenatal or miscarriage analysis of aneuploidies in chromosomes 13, 15, 16, 18, 21, 22 and XY

> Devyser Extend v2

Devyser Resolution XY v2

Capillary Electrophoresis Reproductive
Rapid protocol for advanced reflex or resolution aneuploidy testing of chromosomes X and Y using QF-PCR analysis.

Devyser Resolution XY v2 is a QF-PCR kit for extended aneuploidy analysis of chromosomes X and Y.

Resolution or reflex testing

The kit enables advanced marker resolution capabilities by combining genetic markers used in the Devyser Complete v2 and Devyser Compact v3 kits with additional markers for reflex testing or for extended chromosome specific analyses. The kit allows analysis of totally seventeen (17) genetic markers on chromosomes X and Y for reflex testing or for other chromosome specific analyses requested.

The Devyser Resolution XY v2 kit allows analysis of three (3) unique X-chromosome counting markers for reliable detection of Turner syndrome.

SINGLE MIX QF-PCR

One single PCR mix for rapid prenatal aneuploidy analysis of 26 genetic markers on chromosomes 13, 18, 21 and XY.

Devyser Compact v3

EXTENDED ANEUPLOIDY ANALYSIS

Rapid prenatal or miscarriage analysis of aneuploidies in chromosomes 13, 15, 16, 18, 21, 22 and XY

> Devyser Extend v2

Devyser Resolution 18 v2

Capillary Electrophoresis Reproductive
Rapid protocol for advanced reflex or resolution aneuploidy testing of chromosome 18 using QF-PCR analysis.

Devyser Resolution 18 v2 is a QF-PCR kit for extended aneuploidy analysis of chromosome 18. The kit enables advanced marker resolution capabilities by combining STR markers used in the Devyser Complete v2 and Devyser Compact v3 kits with additional markers for reflex testing or for extended chromosome specific analyses. The kit allows analysis of totally nine (9) STR markers on chromosome 18 for reflex testing or for other chromosome specific analyses requested.

SINGLE MIX QF-PCR

One single PCR mix for rapid prenatal aneuploidy analysis of 26 genetic markers on chromosomes 13, 18, 21 and XY.

Devyser Compact v3

EXTENDED ANEUPLOIDY ANALYSIS

Rapid prenatal or miscarriage analysis of aneuploidies in chromosomes 13, 15, 16, 18, 21, 22 and XY

> Devyser Extend v2

Devyser Resolution 13 v2

Capillary Electrophoresis Reproductive
Rapid protocol for advanced reflex or resolution aneuploidy testing of chromosome 13 using QF-PCR analysis.

Devyser Resolution 13 v2 is a QF-PCR kit for analysis of chromosome 13. The kit enables advanced marker resolution capabilities by combining STR markers used in the Devyser Complete v2 and Devyser Compact v3 kits with additional markers for reflex testing or for extended chromosome specific analyses. The kit allows analysis of totally nine (9) STR markers on chromosome 13 for reflex testing or for other chromosome specific analyses requested.

SINGLE MIX QF-PCR

One single PCR mix for rapid prenatal aneuploidy analysis of 26 genetic markers on chromosomes 13, 18, 21 and XY.

Devyser Compact v3

EXTENDED ANEUPLOIDY ANALYSIS

Rapid prenatal or miscarriage analysis of aneuploidies in chromosomes 13, 15, 16, 18, 21, 22 and XY

> Devyser Extend v2

Devyser APOE

Capillary Electrophoresis Hereditary
The Devyser APOE kit is an in vitro diagnostic product for determination of the apolipoprotein E (APOE) genotype

Apolipoprotein E (APOE) and disease

High blood cholesterol is a major risk factor for cardiovascular diseases. Genetic variations in the APOE gene have been shown to be associated with increased levels of blood cholesterol in response to dietary fat. In addition, certain APOE genotypes are associated with late-onset Alzheimer’s disease. The Devyser APOE kit allows identification of all relevant APOE genotypes.

Genotyping of APOE

The APOE ε3 allele is the most common of the APOE alleles, and is associated with normal levels of blood cholesterol. No increased risk of developing Alzheimer’s disease has been shown.

APOE ε4 carriers are prone to high LDL cholesterol, coronary heart disease, atherosclerosis and Alzheimer’s disease. Low-fat diets can help reduce the risk of developing these diseases.

The APOE ε2 allele is associated with low LDL cholesterol and low incidence of coronary heart disease. In contrast, carriers of the E2/2 genotype may be prone to type III hyperlipoproteinaemia in the presence of other environmental or genetic factors. APOE ε2 appears to reduce the risk of Alzheimer’s disease.

Genotype risks are dose dependent. Genotypes E2/2 and E4/4 are the two extremes while E2/4 is similar to E3/3. E2/3 risks are between that of E2/2 and E3/3; and the risks associated with E3/4 are between that of E3/3 and E4/4. APOE genotyping can facilitate appropriate counseling and thereby lowering an individual's risk for cardiovascular disease.

Devyser APOE

The Devyser APOE kit determines the APOE genotype in the risk assessment of hyperlipoproteinemia, coronary heart disease and Alzheimer’s disease.

Key benefits

  • A single mix allows testing of all Apolipoprotein E (APOE) genotypes
  • Single tube PCR minimizes hands-on time
  • Single tube PCR reduces analysis times while minimizing the risk of sample mix up
  • Designed to allow combined detection with the Devyser CVD kit

Risk factors for Thrombophilia

> Devyser Thrombophilia

Genetic risk factors for cvd

> Devyser CVD

Devyser Library Clean

Accessories Next Generation Sequencing
NGS library purification

The Devyser Library Clean kit is intended for library purification together with Devyser BRCA and Devyser CFTR.

NGS LIBRARY KIT FOR BRCA ANALYSIS

Devyser BRCA

Single tube NGS library preparation for BRCA1 and BRCA2

NGS LIBRARY KIT FOR CFTR ANALYSIS

Devyser CFTR

Single tube NGS library preparation for the CFTR gene

Devyser CVD

Capillary Electrophoresis Hereditary
The Devyser CVD kit is an in vitro diagnostic product for qualitative detection of genetic risk factors for the development of cardiovascular disease (CVD)

Genetic risk factors for CVD

Atherosclerosis and venous thrombosis are two major manifestations of CVD. Both can be caused by complex interactions of environmental and genetic factors. An unhealthy lifestyle in combination with genetic risk factors can contribute to the occurrence of CVD. Similarly, a combination of adverse influences (female hormone intake, immobilization, surgery or cancer) and variations in genes responsible for the coagulation system can contribute to CVD. Testing for genetic risk factors can therefore be a powerful tool for guidance to a lifestyle that is in accordance with an individual’s genetic predisposition.

Devyser CVD

The Devyser CVD kit offers a very simple procedure for identification of mutations and polymorphisms implicated as genetic risk factors for the development of CVD. It is a multiplex PCR reagent kit for simultaneous detection of seven genetic risk factors associated with CVD:

Factor XIII (F13A1)

The V34L variant plays a protective role against venous thrombosis. It has also been associated with lower risk for stroke and myocardial infarction.

Fibrinogen Beta Chain (FGB)

The -455G>A polymorphism in the promoter region of the FGB gene is associated with elevated plasma fibrinogen levels, an independent predictor of coronary heart disease.

Human Platelet Antigen 1 (HPA1b)/Platelet receptor GPIIIa/(ITGB3)

HPA1b is associated with an increased risk of myocardial infarction and stroke.

Angiotensin Converting Enzyme (ACE)

The 287bp gene deletion/insertion polymorphism is associated with an increased risk for hypertension and for myocardial infarction in elderly patients and smokers.

Angiotensin/ Angiotensinogen (AGT)

The M268T polymorphism has been associated with an increased risk of hypertension.

Angiotensin II type 1 receptor (AGTR1)

The 1166A>C (c.*86A>C) polymorphism is associated with an increased risk for hypertension and CVD.

Cystathionine Beta-Synthase (CBS)

The 844ins68 variant has been associated with an increased risk of premature occlusive arterial disease.

Key benefits

  • A single mix allows testing of seven relevant risk factors for cardiovascular disease
  • Single tube PCR minimizes hands-on time
  • Single tube PCR reduces analysis times while minimizing the risk of sample mix up
  • Designed to allow combined detection with the Devyser APOE kit

Risk factors for Thrombophilia

> Devyser Thrombophilia

APOE determination

> Devyser APOE

560 sizer orange

Accessories Capillary Electrophoresis
Size marker optimised for use with all Devyser products for capillary electrophoresis

The Devyser 560 SIZER ORANGE size marker for capillary electtrophoresis is designed to provide consistent intensities and migration pattern and is compatible with the most commonly used fluorescent dye-sets where an orange colour size marker is needed for capillary electrophoresis analysis. The fragments included in the 560 SIZER ORANGE size marker are uniformly spaced to provide accurate base calling and precise sizing of DNA fragments.

Advantages

Accuracy

The 560 SIZER ORANGE size marker is evaluated for resolution, intensity and background on capillary electrophoresis genetic analysers. It is free of extraneous peaks over its entire sizing range. In addition, the marker produces consistent within run and between run sizing creating a size curve that is linear.

Speed and Ease of use

Optimised for use with all Devyser's capillary electophoresis products.

Dye-set calibration

Dye-set calibration of multi- or single capillary instruments

DEV-5 Dye-sets

SINGLE MIX QF-PCR

Rapid aneuploidy analysis of chromosomes 13, 18, 21, X and Y

> Devyser Compact v3

Devyser DEV-5 Dye Set Calibrators

Accessories Capillary Electrophoresis
DEV-5 Dye-set calibrators and Matrix standards for capillary electrophoresis

DEV-5 Dye-set calibration and Matrix standards are suitable for spectral calibration and matrix file generation on capillary electrophoresis instruments.

  • Use the MultiCap calibration reagents for spectral calibration of multi capillary instruments (e.g. ABI 3100, 3130, 3500 and 3730)
  • Use the SingleCap calibration reagents for matrix file generation on single capillary instruments (e.g. ABI 310).

The composition, purity and quality of all calibration reagents undergo strict quality controls.