Devyser NGS kits

BRCA1 and BRCA2 genes are tumour suppressor genes. Mutations in these genes may produce a hereditary breast-ovarian cancer syndrome in affected persons. Early identification of germline BRCA mutations can help physicians make informed decisions on risk reduction strategies. Analysis of somatic mutations can help clinicians tailor targeted treatment for ovarian and breast cancer patients.

Devyser BRCA

Devyser BRCA is rapid targeted NGS library preparation assay intended for the detection of variants in BRCA1 and BRCA2 genes. 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. Devyser BRCA is CE-IVD marked.

• One tube per patient sample, no sample splitting
• The proprietary multiplex PCR primer chemistry provides full and uniform coverage of BRCA1 and BRCA2, covering all exons and exon/intron junctions.
• One kit for both germline and somatic mutations
• User friendly workflow with 45 mins hands-on time and a total laboratory process time of five hours from DNA to sequencing

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Devyser HBOC

Devyser HBOC is rapid targeted NGS library preparation assay intended for the detection of variants in BRCA1, BRCA2 and 12 additional genes where mutations are known to significantly increase the risk of developing breast and ovarian cancer.

Devyser BRCA and Devyser HBOC can be used simultaneously. Devyser HBOC kit can also be used as a stand-alone follow-up after negative BRCA testing with Devyser BRCA.

• Targeted sequencing of 12 genes relevant for hereditary breast and ovarian cancers (HBOC): ATM, PTEN, BARD1, RAD51C, RAD51D, BRIP1, CDH1, STK11, CHEK2, TP53, NBN, PLAB2
• End-to-end CE-IVD solution including NGS library preparation and a customised data interpretation software
• User friendly workflow with 45 mins hands-on time and a total laboratory process time of five hours from DNA to sequencing

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CFTR mutation testing can be used in diagnosis of cystic fibrosis, male infertility caused by CBAVD, and acute recurrent or chronic pancreatitis. It can also be used to guide targeted therapies, and as an aid in newborn screening.

Devyser CFTR

Devyser’s CE-IVD single tube NGS library prep kit for targeted, complete CFTR gene sequencing. Kit has ready-to-use reagents and a user-friendly workflow.

• One tube per sample means no need for sample splitting
• Reduce hands-on time from days to under 45 minutes
• Direct detection of CNVs
• Detect all mutations in the coding regions of the CFTR gene
• Determination of poly-T and TG repeats

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FH (familial hypercholesterolaemia) is a predominantly inherited lifelong condition, in which high cholesterol levels in the blood often lead to cardiovascular disease. If detected early enough, the disease can be treated with statins or PCSK9 inhibitors.

FH may be caused by mutations in the LDLR, APOB, PCSK9, APOE, STAP1 and LDLRAP1 genes, for example, all of which can be identified by Devyser’s FH kit. In addition, the kit enables the analysis of 12 polygenic SNPs affecting LDL cholesterol levels in the same test.

High LDL cholesterol levels are commonly treated with statins, but there are individual differences in the response to the medication. Devyser’s kit allows the detection of not only mutations and polygenic SNPs associated with FH, but also six SNPs associated with response on statins.

Devyser FH

• Analyses all genes involved in FH diagnosis and statin response in one test
• Identifies all copy number variations in the LDLR gene
• Devyser’s easy-to-use NGS library prep
• One tube per patient sample
• Duration of the manual phases less than 45 minutes

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Alpha and beta thalassaemia are serious blood diseases, in which mutations in the globin genes lead to structural instability of the haemoglobin. The diseases are congenital and involve autosomal recessive inheritance. Alpha thalassaemia is most often caused by the deletion of one or both HBA genes, while beta thalassaemia is usually caused by the variation of one nucleotide in the HBB gene.

Devyser Thalassemia

Devyser’s Thalassemia kit provides an easy-to-use comprehensive NGS library that enables comprehensive diagnostics of both alpha and beta thalassemia with a single test. The kit is CE-IVD marked.

• The test recognises both SNVs and deletions in the HBA1, HBA2 and HBB genes
• Direct indication of 17 general deletions
• One tube per patient sample
• Duration of the manual phases less than 45 minutes

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Lynch syndrome, also known as hereditary non-polyposis colorectal cancer (HNPCC), is a genetic condition that increases the risk of developing several types of Lynch syndrome-associated cancer. It is an autosomal dominant syndrome that can result from mutations in five different genes and is challenging to test for accurately and reliably, due a lack of characterization of the numerous associated gene variants and misattribution of mutations between genes and pseudogenes.

Devyser LynchFAP

Devyser LynchFAP is a targeted next-generation sequencing (NGS) assay for the analysis of genes associated with hereditary colon cancer syndromes; Lynch syndrome, Familial Adenomatous Polyposis (FAP), and MUTYH-Associated Polyposis (MAP).

• Sequencing of SNVs, CNVs, and indels in10 genes related to the most common colorectal hereditary cancers
• One-stop solution including a long-range PCR to confidently distinguish PMS2 variants from its pseudogene PMS2CL in all exons
• Evaluate PMS2-specific variants and gene conversion rates with the aid of a dedicated software

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