As a global molecular diagnostics product and solutions company, Asuragen uses a unique combination of proprietary chemistries and bioinformatics to develop products that address unmet needs for both clinical research and laboratories. Asuragen's product portfolio is comprised of reagent kits for Genetics and Oncology applications. Leveraging its core technologies and resources, Asuragen also delivers custom discovery, design and development services to support a wide range of needs for IVD products.
Genetics
The AmplideX® suite of products is designed to solve unmet testing needs in inherited genetic disorders. The technology overcame a 20-year challenge by reliably amplifying the FMR1 gene. It allowed researchers to gain a deeper understanding of fragile X syndrome, the most common known inherited cause of intellectual disability and autism. Asuragen has also pioneered innovation in other major areas.
AmplideX® PCR/CE SMN1/2 Plus Kit
The AmplideX® SMA Plus Kit* is an in vitro nucleic acid amplification kit intended to aid in the screening of carriers for and diagnosis of spinal muscular atrophy (SMA). The kit quantifies the number of copies of exon 7 of both SMN1 and SMN2 reported as 0, 1, 2, 3, or ≥ 4 genomic copies. The kit is designed for PCR with extracted genomic DNA from human whole blood performed on standard laboratory-validated thermal cyclers, followed by resolution on a general laboratory-validated genetic analyzer or capillary electrophoresis (CE) platform.
AmplideX® PCR/CE CFTR Kit
The AmplideX® PCR/CE CFTR Kit* brings the simplicity and scalability of AmplideX technology to CFTR variant detection. Offering the streamlined detection of 67 pathogenic variants, and covering approximately 93%† of the US population, the assay provides the broadest coverage of any commercially available, targeted testing kit. The assay is optimized for use on widely established laboratory equipment and delivers genotype results from DNA in just five hours.
AmplideX® PCR/CE FMR1 Kit
AmplideX PCR/CE FMR1 Kit is an in vitro diagnostic (IVD) device for use in clinical laboratories for detection of the CGG repeats in the fragile X mental retardation (FMR1) gene. The device is intended to aid in the diagnosis of fragile X syndrome and fragile X associated disorders, e.g. tremor and ataxia syndrome (FX-TAS) and primary ovarian insufficiency (FXPOI), through determination of CGG repeat length up to 200 CGG and detection of alleles greater than 200 CGG.
AmplideX® mPCR FMR1
The AmplideX mPCR FMR1 Kit employs an innovative PCR-only approach for the detection of methylation status in the FMR1 gene. These reagents determine the extent of methylation of each individual allele in both male and female samples, and thus eliminate the need to run tedious and time consuming Southern blots.
AmplideX® FMR1 Controls
The AmplideX FMR1 Controls are proprietary mixtures of genomic DNA containing multiple alleles. These well characterized controls can be used as process or batch controls covering multiple size ranges and different methylation states in the FMR1 gene.
AmplideX® Fragile X Dx & Carrier Screen Kit
The AmplideX® Fragile X Dx & Carrier Screen Kit is an in vitro diagnostic device that uses polymerase chain reaction (PCR) and capillary electrophoresis to detect and identify the number of cytosine-guanine-guanine (CGG) repeats in the fragile X mental retardation-1 (FMR1) gene using genomic DNA isolated from peripheral whole blood specimens.
Oncology
The Asuragen Oncology portfolio uses proprietary molecular chemistry and informatics solutions to deliver critical clinical research insights that drive the evolution of therapy, patient monitoring and precision medicine. The QuantideX® suite of products employs molecular methods ranging from qPCR to NGS to help advance our understanding of cancer. Our approach is to selectively deploy the right technology for the right result.
QuantideX® qPCR BCR-ABL IS Kit
Assessing complete molecular response requires the highest possible assay sensitivity. The FDA-cleared QuantideX® qPCR BCR-ABL IS Kit takes chronic myeloid leukemia (CML) monitoring to a new level of sensitivity – 0.002% IS (MR4.7). It’s a qPCR-based in vitro Diagnostic test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t(9;22) positive CML patients expressing e13a2 and/or e14a2 fusion transcripts.
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