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Intermountain Precision Genomics RxMatch

Sep 07, 2017

Intermountain Precision Genomics Core Laboratory launched RxMatch, a new service to enable physicians to implement personalized medicine when prescribing medications. The RxMatch Antidepressant Panel, launched Sept. 5 as part of the new service, will allow physicians to use patients' genomics to find the right antidepressant. The RxMatch Antidepressant Panel will be powered by CNSDose, a company that will provide decision support to Intermountain based on its knowledge of liver and blood-brain-barrier metabolism of antidepressant medications.

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Apr 24, 2019

Curiox Biosystems Wash Auto 1000

Curiox Biosystems has launched the Laminar Wash Auto 1000 system for automated flow cytometry sample preparation. It offers turnkey automation and flexibility, the San Carlos, California-based company said, adding the system is preprogrammed with modifiable protocols. 

Apr 24, 2019

Human Diagnostics Worldwide, Eiken Chemical, FIND Malaria-LAMP

Human Diagnostics Worldwide, Eiken Chemical, and the Foundation for Innovative New Diagnostics launched Malaria-LAMP for the detection of malaria caused by Plasmodium vivax parasites. The partners said the test is the first commercially available molecular test for P. vivax-associated malaria. It uses loop-mediated isothermal amplification developed by Eiken and is exclusively distributed by Human Diagnostics. FIND and the Hospital for Tropical Diseases evaluated the prototype test and coordinated in-country clinical performance studies in Columbia and Peru. The test can differentiate between Plasmodium pan species, P. falciparum and P. vivax, and has a sensitivity of 84 percent to 94 percent and a specificity of greater than 92 percent. The limit of detection is one to two parasites per microliter. 

Apr 23, 2019

Roche Ventana HER2 Dual ISH CDx

Roche launched the Ventana HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast and gastric cancer.

HER2 is an important biomarker found in breast and gastric cancers, whose detection and inhibition can help to more effectively manage these aggressive cancers.

The Ventana HER2 Dual ISH DNA Probe Cocktail assay is designed to be completed within one day, enabling clinicians to get results back quicker than the most common methods of confirmatory testing for HER2, Roche said. Results can be read using light microscopy, eliminating the need for a specialized fluorescence microscope.

Apr 22, 2019

MycoDART MycoDART-PCR

MycoDART has launched MycoDART-PCR, a dual amplification real-time PCR DNA test for the rapid detection of Candida aurus. Pending approval by the US Food and Drug Administration, the test can be ordered currently only through RealTime Laboratories and only with a doctor's order. The launch comes amid reports that C. auris, which is highly resistant to antifungal medications, is spreading throughout the US. C. auris is 1 of 6 Candida species that MycoDART-PCR can detect. It offers a specificity and sensitivity of 95 percent and has been validated for blood, body fluids, and tissue MycoDART said. It can also be run to detect for the presence of C. auris on environmental sufraces. For such purposes, a doctor's order is not needed for the test. 

Apr 18, 2019

Quest Diagnostics STD Packages

Quest Diagnostics launched three sexually transmitted disease laboratory test packages that consumers can purchase online. The packages include tests for chlamydia and gonorrhea, trichomonas, hepatitis B and C, syphilis and human immunodeficiency virus, and are available in 45 states throguh QuestDirect, an online consumer-initiated testing service provided by Quest. Test results are available on MyQuest, the firm's patient portal. Quest noted that licensed physicians provide oversight of all lab tests, including ordering of the tests and evaluation of the results.

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.