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Bio-Techne Zika ELISA

Sep 07, 2017

R&D Systems, a Bio-Techne brand, launched a rapid solid phase enzyme-linked immunosorbent assay designed to measure anti-Zika virus immunoglobulin G antibodies in human serum. Samples are pre-treated with a proprietary reagent designed to minimize any interfering proteins present in the serum that could produce a false positive result. In-house testing demonstrates that this kit is highly sensitive to anti-Zika virus IgG and displays minimal cross-reactivity with dengue virus IgG antibodies, the firm said.

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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. 

Feb 12, 2019

Myriad Genetics Prequel

Myriad Genetics commercially launched an enhanced version of the Prequel Prenatal Screen. The enhanced noninvasive prenatal screen analyzes 23 chromosome pairs instead of the standard five chromosomes (13, 18, 21, X and Y) it previously gauged. According to the company, the ability to assess additional chromosomes enhances the test's clinical utility by improving aneuploidy detection by 30 percent. Myriad is combining the NIPS Prequel tests with its Foresight Carrier Screen and is marketing them to all female patients, including women who have a high body mass index, are an ovum donor, or have a twin pregnancy. The expanded offering will be available for doctors to order on Feb. 19. 

Feb 12, 2019

Invitae NIPS

Invitae has added non-invasive prenatal screening (NIPS) to its offerings and integrated it as part of the firm's carrier screening test. The NIPS test analyzes cell-free DNA to assess whether a pregnancy is at heightened risk for three common chromosomal disorders, including trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome) and trisomy 13 (Patau syndrome). There is no additional charge for adding microdeletion and sex chromosome analysis. The carrier screen sequences 301 genes linked to serious genetic disorders, and now the same specimen collection kit will also enable NIPS. Invitae will begin accepting NIPS test orders next week.

Feb 07, 2019

ArcticZymes T4 DNA Ligase

ArcticZymes, a Biotec Pharmacon subsidiary, has released a T4 DNA ligase, its first commercial ligase enzyme. T4 DNA ligase is the most widely used enzyme in the ligase family, and works by joining DNA fragments together. It is used in the development of kits and products for in vitro diagnostics and molecular research. The ligase is produced under strict ISO 13485 guidelines, and can be used by customers either in combination with their own enzymes or alongside other ArcticZymes enzymes.

Feb 05, 2019

Baylor Genetics Clinical Whole-Genome Sequencing for Genetic Disorders

Baylor Genetics has launched clinical whole-genome sequencing for the diagnosis of rare genetic and inherited disorders. The test covers various mutation types throughout the genome, including single-nucleotide variants, indels, copy number variants, structural variants, regions of absence of heterozygosity, and repeat expansion variants. It requires a sample from patient and parents and has a turnaround time of 8 to 10 weeks.

Feb 05, 2019

OmegaQuant Analytics Prenatal DHA Test

OmegaQuant Analytics has launched its Prenatal DHA Test, which allows expecting mothers to monitor their omega-3 DHA level. According to the Sioux Falls, South Dakota-based firm, research suggests taking the nutrient DHA may reduce the risk of premature births. 

Feb 05, 2019

Caris Life Sciences MI Transcriptome

Caris Life Sciences has launched a whole-transcriptome assay, MI Transcriptome, to sequence the transcriptome of patients' tumors. The assay generates on average 60 million reads per patient to enable detection of fusions, splice variants, and gene expression. The company plans to submit the assay to the US Food and Drug Administration for pre-market approval review in the first half of the year.