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LabCorp Certolizumab Concentration and Anti-Certolizumab Antibody DoseAssure CTZ Assay

Feb 19, 2019

Laboratory Corporation of America has launched its Certolizumab Concentration and Anti-Certolizumab Antibody DoseAssure CTZ assay. The test is part of the company's therapeutic drug monitoring DoseAssure portfolio and can be used by physicians to monitor individual drug response in patients who are on certolizumab, a monoclonal antibody to TNF-alpha used to treat certain inflammatory diseases. 

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Aug 11, 2020

Centogene CentoMD 5.8

Centogene has released an update to its curated rare disease mutation database, CentoMD 5.8. This latest version includes more than 12.7 million unique variants, greater than 81,000 classified and curated variants, and over 199,000 individuals linked to HPO terms. Since December 2019, the number of cases in CentoMD has grown to more than 430,000, covering over 120 countries.

Aug 07, 2020

NIST: SARS-CoV-2 Synthetic Gene Fragments

Researchers at the National Institute of Standards and Technology have produced synthetic gene fragments from SARS-CoV-2. Shipped in vials with a data sheet listing the concentration of fragments in the solution, the RNA fragments can be used to measure the sensitivity of tests for the coronavirus. They can also use the synthetic RNA to develop more sensitive tests or new kinds of tests, NIST said. Each solution contains about 1 million copies per microliter. NIST is releasing the synthetic RNA as a research grade test material while it expects to further develop it as a standard reference material. The material is free to researchers, test manufacturers, and testing labs. Technical information and instructions for requesting the material are available here.

Aug 06, 2020

GeneDx GenomeXpress

GeneDx, a subsidiary of BioReference Laboratories/Opko Health, has launched GenomeXpress, a rapid genome sequencing test. GenomeXpress includes both protein-coding and non-coding regionsn of the genome including promoter, intronic, and untranslated regions, enabling the detection of characterized/pathogenic variants in regions that are not assessed by exome sequencing. The company delivers a written report for all confirmed variants in known disease-causing genes to the ordering healthcare provider within approximately seven days after testing. It also provides a written report for all confirmed variants within approximately 14 days after the start of testing. 

Aug 04, 2020

Adaptive Biotechnologies ImmunoSeq T-Map COVID Service

Adaptive Biotechnologies has launched the immunoSeq T-Map COVID, a proprietary research product and data-analysis service to measure the T cell immune response to vaccines in development and track the persistence of that response over time.

The product leverages data from more than 1,000 patients to provide researchers with a quantitative map of T cell receptors and SARS-CoV-2 antigens that elicit an immune response. These data will be available through Adaptive's cloud-based immunoSeq Analyzer and is powered by ImmuneCode, an open database developed in partnership with Microsoft.

Aug 03, 2020

Cytek Biosciences cFluor Reagents

Flow cytometry firm Cytek Biosciences announced the launch cFluor reagents, short for "Cytek Fluorochrome," that are validated on the firm's Aurora and Northern Lights full spectrum cell analysis systems. The first batch of reagents includes cFluor YG584, cFluor B548, and cFluor R710 and allows users to reveal more from the full spectrum panel with a new option excitable by the yellow-green, blue, and red lasers respectively. Other dyes are coming soon, the firm said. 

Jul 31, 2020

Myriad Genetics Amplify for Fetal Cell-Free DNA Sequencing

Myriad Genetics has launched Amplify, which sequences the fetal cell-free DNA fragments circulating in a mother's blood and increases the fetal fraction in a sample for non-invasive prenatal screening. The company is hoping that the technology will improve the performance of its Prequel NIPS test. The analytical validation of Amplify involved samples from more than 1,000 women and showed that the fetal fraction was 2.3 times greater on average compared to standard NIPS. The improvement reduces false positive and false negative results, including for common aneuploidies, expanded aneuploidies, microdeletions, and a baby's sex, Myriad noted. The company also said that the technology will reduce the number of sampels that fail to produce a result due to low fetal fraction and deliver results to 99.9 percent of patients. 

Jul 29, 2020

HTG Molecular Diagnostics HTG EdgeSeq Pan B-Cell Lymphoma Panel

HTG Molecular Diagnostics has launched its HTG EdgeSeq Pan B-Cell Lymphoma Panel, which the firm said is designed to provide molecular characteriation of aggressive, indolent, and rare lymphomas. The research-use-only panel enables investigators to measure the expression of about 300 genes linked to the lymphoma transcriptome. The panel is available in kit form or as a service at HTG's VERI/O laboratory. 

Jul 28, 2020

Myriad Genetics: Vectra Report

Myriad Genetics has enhanced its test report for Vectra, a multi-biomarker, molecular blood test for measuring inflammatory disease activity in rheumatoid arthritis patients. The new report provides an estimate of each patient's one-year risk of rapid radiographic progression, factoring in age, gender, and adiposity. Previously, the company reported a measure of patients' current RA inflammation, but the added information in the latest version of the report can inform them of the future risk of joint damage and "further guide [their] medical management decisons," Mark Verratti, president of Myriad Neuroscience and Myriad Autoimmune, said in a statement. 

Jul 23, 2020

SphingoTec IB10 Sphingotest bio-ADM

SphingoTec launched IB10 Sphingotest bio-ADM, a CE IVD-marked point-of-care test to quantitatively determine blood levels of bioactive adrenomedullin. Blood levels of bio-ADM reflect the functional status of the endothelium, the inner cell sheet of blood vessels. The test is available on the company's rapid point-of-care platform Nexus IB10, which uses whole blood samples without pre-processing, requires less than three minutes of hands-on time, and delivers results in about 20 minutes.

Jul 17, 2020

Cepheid Xpert MTB/XDR

Cepheid has launched an assay to detect extensively drug-resistant tuberculosis. The CE-IVD marked Xpert MTB/XDR test uses new 10-color technology and runs on recalibrated GeneXpert instruments. It can be used to rapidly detect resistance to isoniazid, ethionamide, fluoroquinolones, amikacin, kanamycin, and capreomycin directly from patient specimens.

Jul 15, 2020

Congenica Automation

Congenica has updated its clinical decision support platform by launching the Automated Classification of Known Variants product, Congenica Automation. This will provide automated classification as well as evidence and reporting of recurrent 'known' variants that customers observe in their rare disease cases. The new product aims to reduce interpretation and reporting time by 90 percent compared to the company's existing solution, so complex genomic data can be reported in as little as 5 minutes. For example, interpretation and reporting of 4,000 cases with recurrent pathogenic or likely pathogenic variants could be completed in 5 to 8 minutes for each case. Users of the new product can also create their own customized curated variant list to be used for the automated process.

Jul 10, 2020

Bionano Genomics Bionano Prep SP Tissue and Tumor Kit

Bionano Genomics has launched the Bionano Prep SP Tissue and Tumor Kit, a DNA isolation kit for the analysis of tumors and tissues with the company's Saphyr system. The kit is designed to simplify the isolation of ultra-high molecular weight DNA from a variety of solid tumors and tissue types. DNA can be extracted in less than six hours from as little as 5 mg of fresh or frozen tissue. It was validated in bladder, lung, liver, kidney, colon, breast, prostate, brain, thyroid, ovary, testes, and uterus tissue.

Jul 08, 2020

NIST SARS-CoV-2 Research-Grade Test Material

The National Institute of Standards and Technology has developed a reference material to aid in the evaluation and development of RT-qPCR assays for SARS-CoV-2. The reference material consists of two synthetic RNA fragments from the SARS-CoV-2 genome in a background of 5 ng/μL human Jurkat RNA (stored at –80° C, BSL-1). Fragment 1, which has a total length of 3,985 nucleotides, and includes SARS-CoV-2 sequence 25949-29698 of isolate USA-WA1/2020; and Fragment 2, which has a total length of 3,790 nucleotides and includes SARS-CoV-2 sequence 12409-15962 of isolate USA-WA1/2020.

NIST said the synthetic fragments can be used to assess limits of detection for SARS-CoV-2 assays or calibrate other in-house or commercial SARS-CoV-2 controls. NIST characterized the material by size and using multiple reverse transcription droplet-digital PCR and qPCR methods. The agency is making the material free of charge through funding from the Coronavirus Aid, Relief, and Economic Security Act, in exchange for user feedback to help improve and further develop the material. 

Jul 08, 2020

Illumina TruSight Software Suite

Illumina has launched the TruSight Software Suite for genetic disease testing using whole-genome sequencing. It enables sample-to-report analysis, allowing users to go from 5 million variants to a small number of candidates in a rapid and scalable way. The software suite, developed in collaboration with the Mayo Clinic and other experts and offered as a "software as a service" solution, promises to reduce test interpretation time from as much as several weeks to as little as a few hours. It is certified for HIPAA compliance, ISO 27001, and ISO 13485 and is built to enable data privacy and compliance with the principles of the European Union's General Data Protection Regulation.

Jul 01, 2020

Thermo Fisher Scientific MAS Omni Infectious Disease Quality Controls

Thermo Fisher Scientific has launched its MAS Omni Infectious Disease quality control sets for monitoring the performance of serological assays. These new control sets are for analytes such as HIV 1&2, hepatitis B & C virus, syphilis, and human T- cell leukemia virus I/II. These infectious positive and negative quality controls are third-party, independent external controls that can potentially reduce costs without sacrificing quality or throughput of the control set, the firm said. The Thermo Scientific MAS Omni Infectious Controls are available in the US and Japan as IVD products and are intended for clinical use.