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Bio-Rad Laboratories qUAntify Advance Control

Jan 23, 2019

Bio-Rad Laboratories has launched the qUAntify Advance Control for urinalysis testing in clinical labs. The control is used to monitor the precision of laboratory urinalysis test procedures, and it contains human urine solution and offers 31 days of open vial stability for all analytes, including ketones at room temperature. Bio-Rad added that the Unity Interlaboratory Program and Unity QC Data Management Solutions are availabe for use with qUAntify Advance. 

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Apr 10, 2019

Thermo Fisher Scientific CEDIA Mitragynine (Kratom) Assay

Thermo Fisher Scientific launched the CEDIA Mitragynine (Kratom) Assay for laboratorians to test for the presence of kratom. The test, which is for criminal justice and forensic use only, includes supporting calibrators and controls, and can be run on commonly used clinical chemistry analyzers, Thermo Fisher said. 

Apr 08, 2019

Becton Dickinson BD Bactec Platelet Quality Control Media

Becton Dickinson launched its BD Bactec platelet quality control media, which allows microbilogy laboratories, blood banks, and transfusion services to identify contaminated platelet units, and reduce the risk of sepsis. The product is part of a package from BD leveraging the BD Bactec FX technology and BD Synapsys microbiology informatics solution to help labs meet culture-based platelet testing requirements. The BD Bactec platelet is FDA cleared and CE-IVD marked, and can be used for QC testing of leukocyte-reduced aspheresis platelet units, and both leukocyte-reduced single and a pool of up to six units of leukocyte-reduced whole-blood platelet concentrates, the firm said. 

Apr 05, 2019

Fabric Genomics Hereditary Panels With ACE

Fabric Genomics has launched Fabric Hereditary Panels with ACE (AI Classification Engine) software for variant interpretation and clinical reporting. ACE is an artificial intelligence inference engine that leverages deep gene and variant annotation, resulting in highly accurate American College of Medical Genetics variant classification. The software is embedded within the Fabric Enterprise platform for genomic analysis and reporting that delivers a complete sequence-to-clinical report workflow. ACE enhances the Fabric Enterprise platform, making ACMG classification even faster and easier, the company said. The new software is now available for many common genetic tests such as inherited cancer risk including BRCA1 and BRCA2, newborn screening, and CDC-Tier 1 and ACMG incidental findings testing.

Apr 02, 2019

Progenity Resura Prenatal Test for Monogenic Disease; Innatal Prenatal Screen

Progenity has launched the Resura prenatal test for monogenic disease, a customizable, noninvasive prenatal test (NIPT) for single-gene disorders. The test is available to families with known risk for monogenic disease such as cystic fibrosis, sickle cell anemia, and Tay-Sachs disease. The test, which was developed using droplet digital PCR, uses fetal cell-free DNA extracted from a sample of the mother's blood, and can be performed on disease-causing variants of all inheritance types, including recessive, dominant, and X-linked genetic mutations.

Progenity also announced improvements to its Innatal prenatal screen, a NIPT for chromosomal aneuploidies that now provides greater specificity and sensitivity in evaluating aneuploidy across all chromosomes. Specifically, the sequencing-based test has been enhanced in terms of detecting aneuploidies in chromosomes 21, 18, 13, X, and Y, the company said.

Apr 02, 2019

MDNA Life Sciences Endemetriosis Blood Test

MDNA Life Sciences has launch a blood test for endemetriosis. The firm said it is the first blood test for the indication and can detect the disease in up to 9 out of 10 cases. Test results can be available in a few days, allowing doctors to make earlier diagnostic decisions and treatment. According to the West Palm Beach, Florida-based company, its technology is based on using mitochondrial DNA mutations as biomarkers for a range of diseases. A clinical study published in Biomarkers in Medicine, it added, showed that newly identified biomarkers was able to detect endometriosis in blood samples, including in early stages. 

Apr 02, 2019

PerkinElmer, Helix GenePrism:Actionable Insights

PerkinElmer and Helix have launched GenePrism:Actionable Insights, a genetic screening test that they said is the "most comprehensive clinical grade DNA sequencing and interpretation" test currently on the market. The test allows users to learn about their risk for underlying diseases. A user's DNA will be sequenced by Helix and the results will be interpreted by board-certified geneticists at PerkinElmer Genomics using ordered data interpretation network, that firm's proprietary high-throughput software platform. In comparison to other commercial firms that look at a limited number of letters in a gene sequence, GenePrism:Actionable Insights assesses each of 59 genes in its entirety, including BRCA1/2, the partners said. They also noted that PerkinElmer Genomics maintains one of the largest databases of known genetic variations from different ancestries globally providing customers with a more in-depth assessment. 

Mar 21, 2019

Roche Diagnostics Navify Mutation Profiler, Navify Therapy Matcher

Roche Diagnostics has launched Navify Mutational Profiler and Navify Therapy Matcher to support next-gen sequencing-based cancer genomic profiling tests. Both are part of Roche's Navify Decision Support portfolio.

Navify Mutational Profiler is a clinical software that provides annotation, interpretation, and clinical reporting of NGS tests. Navify Therapy Matcher is an optional clinical decision support app that helps clinicians link clinically actionable mutations to therapy options.

Mar 21, 2019

Beckman Coulter Access PCT Assay

Beckman Coulter has launched its Access PCT assay, which helps physicians assess the risk of critically ill patients progressing to severe sepsis or septic shock. Test results, the firm said, are availalbe in less than 20 minutes. The test allows physicians to integrate procalcitonin testing analysis into their routine sepsis workups on core lab analyzers, it added, as a primary or reflex test programmed through Beckman Coulter's Remison Advance middleware, simplifying the lab workflow and optimizing institutional sepsis management protocols. The Access PCT assay received CE marking in late January, a company spokesperson said, and is available for use on the Access Family of Immunoassay Systems, including the Access 2, UniCel DxI 600, and UniCel DxI 800. 

Mar 19, 2019

Strata Oncology StrataNGS

Strata Oncology has launched version 3.0 of StrataNGS, its pan-cancer assay for solid tumors. The updated 500-gene assay sequences DNA and RNA from tumor samples to detect all clinically actionable biomarkers — including microsatellite instability, tumor mutational burden, and PD-L1 — recommended by leading guidelines, in a single test. Test results are provided in a streamlined report that facilitates interpretation and identification of potential treatment options and clinical trials, Strata said.

Mar 14, 2019

Numares Glomerular Filtration Rate Test

Numares announced the global launch of its latest test in the Axinon family, the Clearance Check, used for the assessment of the glomerular filtration rate — how much blood the kidneys filter each minute. The serum test provides the accuracy of tracer-based plasma clearance methods, the firm said. The new test is based on a metabolite constellation analyzed by a technique called magnetic group signaling combined with nuclear magnetic resonance spectroscopy.

Mar 14, 2019

Shield Diagnostics Target-NG

Shield Diagnostics, a CLIA-certified clinical laboratory based in San Jose, California, has launched Target-NG, a rapid molecular test for antibiotic susceptibility in Neisseria gonorrhoeae. The test, which users can run on urine, rectal, and pharyngeal samples, can determine if a given gonorrhea infection is susceptible to ciprofloxacin with the same turnaround time as standard gonorrhea screening tests, the company said.

Mar 14, 2019

Lonza Lucetta 2 Luminometer

Lonza has launched the Lucetta 2 Luminometer, a single-tube system for simplifying and accelerating mycoplasma detection in cell cultures. The instrument can be used to run Lonza's MycoAlert Mycoplasma Detection Assays with results available within 20 minutes, the firm said. 

Mar 07, 2019

LGC, Biosearch Technologies RapiDxFire Thermostable RT

LGC, Biosearch Technologies has launched RapidDxFire Thermostable RT, a thermostable reverse transcriptase designed specifically for diagnostic kit developers. The enzyme's optimum temperature of 55° C to 80° C improves reaction specificity and allows synthesis from diverse RNA templates. It also has a reaction time of five minutes or less, and is recommended for targets under 1 kb. Its extended stability at room temperature make it compatible with automation, and the enzyme is available in a lyophilization-ready Triton X-100-free format, the company said.

Feb 25, 2019

Medical Database LDS, LDS Analytics

Medical Database introduced two new clinical laboratory decision support products, LDS and LDS Analytics. The LDS platform helps clinicians choose and order appropriate diagnostic tests according to diagnosis, symptoms, and ICD-10 codes to assure that the tests meet payor "medical necessity" guidelines. The LDS Analytics product is an enterprise analytics system to check every claim for medical necessity and assure that the provider has included the most appropriate CPT or ICD-10 code for maximum reimbursement.

Feb 19, 2019

LabCorp Certolizumab Concentration and Anti-Certolizumab Antibody DoseAssure CTZ Assay

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. 

Apr
30
Sponsored by
Lexogen

This webinar will discuss novel long-read transcript sequencing (LRTseq) methods for transcriptome annotation that could increase the efficiency and accuracy of future sequencing projects.

May
21
Sponsored by
Qiagen

This webinar will provide a first-hand look at how a hematology/oncology lab in the UK set up and validated three molecular assays for routine in-house use.

May
22

This webinar will outline the entire liquid biopsy workflow from cell-free DNA isolation to mutation detection by Crystal Digital PCR with the Naica System from Stilla Technologies.