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Glossary Term
EU Regulation 2017/746 governing in vitro diagnostics, which replaced the IVDD with stricter evidence, post-market surveillance, and reclassification rules. Products legacy-listed under the IVDD may still carry transitional timelines, so registration status should be verified per product and per market.
Company
3billion is an IVD supplier based in South Korea, with a source-linked product portfolio. AI Diagnostics.
Company
Abbott Molecular Inc. is an IVD supplier based in United States, with a source-linked product portfolio. Molecular Assays. Coverage spans Instruments | qPCR.
Company
one of the top 3 manufacturers of quality Clinical Chemistry Reagents and Urinalysis Test Strips with over 40 years of expertise in this area.
Company
Agappe Diagnostics Ltd. is an IVD supplier based in India, with a source-linked product portfolio. Molecular Diagnostics. Coverage spans Instruments, Sample Preparation, Molecular Assays | Respiratory.
Company
established in 1974. We develop, manufacture, and distribute reliable and fast CE marked diagnostic tests for point of care. Our aim is to aid global
Product
Technology
A modified polymerase chain reaction (PCR) technique in which a specific primer can amplify its corresponding allele only; this allows for the determination of the presence or absence of a single, specific allele during genotype testing.
Company
Anatolia Geneworks is an IVD supplier based in Turkey, with a source-linked product portfolio. Molecular Assays. Coverage spans Molecular Assays | qPCR | Gastrointestinal.
Technology
A technique designed to rapidly enrich and amplify targets derived from samples that yield low levels of nucleic acids, such as formalin-fixed paraffin-embedded (FFPE) tissues, for use in next-generation sequencing. Briefly, total nucleic acid or genomic DNA (gDNA) is isolated from fresh or FFPE tissues. Total nucleic acid is converted to double-stranded cDNA (dscDNA) and cleaned by solid-phase reversible immobilization (SPRI). Then the dscDNA or gDNA is subjected to end repair, adenylation and ligation with a universal half-functional adapter. The modified DNA sample is then subjected to two rounds of nested low-cycle PCR, where the first round uses target gene-specific primers and the second round uses nested target gene-specific primers that are 5' tagged with a common sequencing adapter. The resulting target amplicon library is cleaned using SPRI and is suitable for use in next generation genomic assays.
Technology
A molecular cytogenetic method combining chromosomal comparative genomic hybridization technique and microarray to detect chromosomal aberrations and changes in DNA copy numbers in the genome, using oligonucleotides immobilized on a solid support as targets for hybridization.
Technology
A molecular genetic technique that isolates and sequences chromosomal regions that are rich in open chromatin. First, nuclei are harvested from a cellular sample. Then a hyperactive Tn5 transposase is added to the nuclei where it excises non-nucleosomal DNA strands and ligates co-administered high-throughput sequencing adapters (tagmentation). The tagged DNA fragments are isolated, amplified by PCR and sequenced. The number of reads for specific region of DNA correlate with increased chromatin accessibility and this method can identify regions of transcription factor and nucleosome binding.
