DiaCarta, Inc

DiaCarta, Inc

DiaCarta is a precision molecular diagnostics company that has developed innovative technologies that transform patient care by providing effective precision diagnostics using liquid biopsy. Underpinned by its proprietary XNA technology and SuperbDNA™ technology platforms, DiaCarta offers a range of products and testin ...
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Covid-19 DiaCarta, Inc

Laboratorio clínico

SARS-CoV-2 (COVID-19) Test
QuantiVirus SARS-CoV-2 Multiplex Test Kit

The QuantiVirus SARS-CoV-2 Multiplex Test Kit is based on Real-Time PCR technology, developed for specific detection of SARS-CoV-2 (COVID-19) viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum. The analytical sensitivity is 50 copies per mL of SARS-CoV-2 viral with a 95% confidence.
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Actualizado

EGFR Mutation Detection Test
QClamp

The QClamp EGFR Mutation Detection Test for Formalin-Fixed Paraffin-Embedded (FFPE) samples aids in the identification of patients eligible for cancer treatment and monitor response to therapy, which can lead to improved outcomes in cancer patients. It is an in vitro diagnostic real-time quantitative PCR assay for the detection of somatic mutations in and near codon 719 in Exon 18, Exon 19 deletions, codons 790, and insertions in Exon 20, and codons 858 and 861 in Exon 21 in the human EGFR gene, using purified DNA extracted from FFPE (for CE/IVD version) or plasma (for research use version).
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Automatic Immunoassay Analyzer
A1

The A1 portable immunoassay analyzer is designed for the quantitative testing of one or several specific proteins in human fluid samples. The test menu includes diabetes, inflammation, cardiac, autoimmune, complement, fertility, bone metabolism, immunoglobulin, liver function, tumor marker, kidney function, metabolism, coagulation marker, anemia, infectious disease, and blood lipid.
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Immunochemical Fecal Occult Blood Test
iColon iFOB Test

The iColon iFOB Test (Immunochemical Fecal Occult Blood Test) is a qualitative immunoassay for detecting fecal occult blood. It can aid the detection of human blood in the stool as found in several gastrointestinal disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer.
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Laboratorio clínico

EGFR Mutation Detection Test
QClamp

The QClamp EGFR Mutation Detection Test for Formalin-Fixed Paraffin-Embedded (FFPE) samples aids in the identification of patients eligible for cancer treatment and monitor response to therapy, which can lead to improved outcomes in cancer patients. It is an in vitro diagnostic real-time quantitative PCR assay for the detection of somatic mutations in and near codon 719 in Exon 18, Exon 19 deletions, codons 790, and insertions in Exon 20, and codons 858 and 861 in Exon 21 in the human EGFR gene, using purified DNA extracted from FFPE (for CE/IVD version) or plasma (for research use version).
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Automatic Immunoassay Analyzer
A1

The A1 portable immunoassay analyzer is designed for the quantitative testing of one or several specific proteins in human fluid samples. The test menu includes diabetes, inflammation, cardiac, autoimmune, complement, fertility, bone metabolism, immunoglobulin, liver function, tumor marker, kidney function, metabolism, coagulation marker, anemia, infectious disease, and blood lipid.
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Immunochemical Fecal Occult Blood Test
iColon iFOB Test

The iColon iFOB Test (Immunochemical Fecal Occult Blood Test) is a qualitative immunoassay for detecting fecal occult blood. It can aid the detection of human blood in the stool as found in several gastrointestinal disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer.
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Handheld Fluorescence Immunoassay Analyzer
Palm F

Palm F is a handheld fluorescence immunoassay analyzer that can provide vitally important health information at the fingertip on the go. It emits light as a result of the antigen-antibody binding in the cassette, causing the attached substrate to fluoresce, resulting in a photoelectric signal the strength of which correlates to the number of fluorescent molecules.
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Bladder Cancer Urine Test
Oncuria Test

Oncuria is designed to quantify 10 protein biomarkers, aiming at a bladder cancer associated diagnostic signature in voided urine samples from individuals who are suspected of bladder cancer. It includes three tests including the Oncuria Detect, Oncuria Monitor, and Oncuria Predict.
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ROS1 Gene Fusions Detection Kit
QFusion ROS1 Fusion Gene Detection Kit

The QFusion ROS1 Fusion Gene Detection kit is a real-time RT-qPCR-based in vitro diagnostic test intended for qualitative and indiscriminatory detection of seven ROS1 fusions in RNA extracted from cells, tissues, and formalin-fixed paraffin-embedded (FFPE) samples. XNA-based ROS1 fusion detection can increase assay sensitivity (reducing false negatives) and specificity (reducing false positives).
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Monkeypox Virus Test
QuantiVirus MPXV Test Kit

The QuantiVirus MPXV Test Kit is a gold standard qPCR test that directly detects the presence of the monkeypox virus viral DNA and has been validated on commonly used instruments with a detection limit of 25 to 80 copies/ml sample. By detecting the two virus-specific genes, J2L and B6R, using the human RNase P as a control, this qPCR multiplex assay can detect the targets and control them in one reaction tube.
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Radiotherapy Toxicity Measurement Assay
Radiotherapy Toxicity Measurement Assay

The Radiotherapy Toxicity Measurement Assay is developed to monitor tissue damage-related toxicity from radiation therapy, allow dose escalation to tumors in less sensitive patients, aid development of radiotoxicity mitigators, and reduce overtreatment risk for sensitive patients. It provides fast, cost-effective quantitation of liquid biopsy cfDNA sample from cancer patients before and after radiation therapy and provides patient information for estimates of dosage usage and general radiation resistance.
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cfDNA Quantification Test
Direct cfDNA Quantification Tests

DiaCarta’s Direct cfDNA Quantification Tests, available as QuantiDNA assays, measure the ng/ml level of cfDNA concentration in human plasma using a luminometer (QuantiDNA DNA Measurement Assay) and Luminex MAGPIX (QuantiDNA Direct cfDNA Test). Unlike the majority of the cfDNA quantification methods that need to extract DNA first before measuring the DNA concentration, DiaCarta’s Direct cfDNA Quantification Tests do not need the isolation of cfDNA for quantitation and provide more reliable results because it eliminates DNA loss during DNA extraction. In addition, it uses only a few microliters of plasma for cfDNA quantitation.
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NRAS Mutation Detection Test
QClamp

The QClamp NRAS Mutation Detection Test is an in vitro diagnostic real-time quantitative PCR assay for the detection of somatic mutations in and near codons 12 and 13 in Exon 2, codons 59 and 61 in Exon 3, and codons 117 and 146 in Exon 4 in the human NRAS gene, using purified DNA extracted from FFPE or plasma. The test for plasma and Formalin-Fixed Paraffin-Embedded (FFPE) samples aids in the identification of patients eligible for cancer treatment and in monitoring response to therapy, which can lead to improved outcomes in cancer patients.
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EML4-ALK/KIF5B-ALK Fusion Gene Detection Test
QFusion EML4-ALK and KIF5B-ALK Fusion Gene Detection Test

QFusion ALK fusion gene detection kits provide an easy-to-use multiplex RT-qPCR assay that simultaneously detects the most prevalent EML4-ALK and KIF5B gene fusion breakpoints. The highly specific and sensitive CE/IVD-certified assay requires a minimal amount of RNA, and it is a rapid and reliable alternative to the laborious FISH test.
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HPV E6/E7 mRNA Test
QuantiVirus HPV E6/E7 mRNA Test

QuantiVirus HPV E6/E7 mRNA Test is a CE/IVD-certified, highly sensitive and specific signal amplification nucleic acid probe assay for predicting pre-cancer in cervical cancer and head & neck cancer screening. Unlike HPV DNA tests, the test focuses on persistent infections, rather than transient ones, thus proving a better predictor of CIN2+ lesions. It may be used as triage of HPV DNA+ samples as an alternative to cytology that needs extensive experience and is operator-dependent.
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Luminometer
DiaCarta Luminometer

The DiaCarta Luminometer, used together with QuantiDNA DNA Quantification Tests or Assays, is designed for the modern diagnostic laboratory delivering high levels of sensitivity and precision from a compact and easy-to-use platform. The system contains a computer system that can be used independently to generate reports.
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Thermal Shaker Incubator
Thermal Shaker Incubator

DiaCarta’s Thermal Shaker Incubator is designed for 1-4 standard 96 well plates in the thermostat mode, including incubation and shaking functions, and can be used for QuantiDNA DNA Quantification Assays. It offers two-side heating of micro-test plates that allows achieving exact correspondence of the set and actual temperature in wells of the micro-test plates.
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Gene Mutation Detection qPCR-Based Assays
QClamp Gene Mutation Detection Tests

QClamp Gene Mutation Detection Tests are highly sensitive qPCR-based assays for tissue biopsy (FFPE) and liquid biopsy (ctDNA) applications. QClamp assays reliably detect 0.1% to 0.5% mutant DNA out of wild-type DNA for targeted mutations, providing lower detection limit compared to similar assays available in the market due to robust enrichment of mutant sequences while suppressing amplification of wild-type sequences.
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SARS-CoV-2 (COVID-19) Test
QuantiVirus SARS-CoV-2 Multiplex Test Kit

The QuantiVirus SARS-CoV-2 Multiplex Test Kit is based on Real-Time PCR technology, developed for specific detection of SARS-CoV-2 (COVID-19) viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum. The analytical sensitivity is 50 copies per mL of SARS-CoV-2 viral with a 95% confidence.
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Tumor Response & Progression Test
RadTox cfDNA Test

The DiaCarta RadTox Test is a simple blood test to monitor tumor response & progression after treatment by monitoring changes in cell-free circulating DNA (cfDNA) levels and is intended to offer an early assessment of patient response to treatment. Based on DiaCarta’s proprietary QuantiDNA Direct cfDNA Test technology, it directly measures the concentration of circulating cfDNA in blood sample, and is used to monitor the cfDNA levels during treatment, such as radiation therapy (radiotherapy), chemotherapy, immunotherapy, and other anti-cancer therapies.
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Colorectal Cancer Mutation Detection Test
ColoScape Colorectal Cancer Mutation Detection Test

The ColoScape Colorectal Cancer Mutation Detection Test is a novel highly sensitive in vitro diagnostic assay using the qPCR-based multi-gene panel for the qualitative detection of colorectal cancer-associated gene mutations in liquid biopsy and FFPE tissue samples. The assay utilizes DiaCarta’s XNA technology to identify the presence or absence of mutations in the targeted regions of four colon cancer-associated genes and can be performed on qPCR instrumentation that is already available in hospital pathology laboratories.
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Pruebas Punto de Atención

Automatic Immunoassay Analyzer
A1

The A1 portable immunoassay analyzer is designed for the quantitative testing of one or several specific proteins in human fluid samples. The test menu includes diabetes, inflammation, cardiac, autoimmune, complement, fertility, bone metabolism, immunoglobulin, liver function, tumor marker, kidney function, metabolism, coagulation marker, anemia, infectious disease, and blood lipid.
Mas detalles

Handheld Fluorescence Immunoassay Analyzer
Palm F

Palm F is a handheld fluorescence immunoassay analyzer that can provide vitally important health information at the fingertip on the go. It emits light as a result of the antigen-antibody binding in the cassette, causing the attached substrate to fluoresce, resulting in a photoelectric signal the strength of which correlates to the number of fluorescent molecules.
Mas detalles
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