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Jun 25, 2019

Co-Diagnostics Zika, Dengue, Chikungunya Multiplex Test

Co-Diagnostics announced the launch of its Logix Smart ZDC multiplex test at the 64th Annual 2019 Caribbean Public Health Agency Health Research Conference in Trinidad and Tobago.

The firm designed the ZDC multiplex test to detect the presence of Zika, dengue, and chikungunya within a single polymerase chain reaction assay. The firm said that the performance of the test confirms the heightened specificity provided by its CoPrimer platform in multiplex PCR applications. Co-Diagnostics received CE marking for the ZDC multiplex test in the first quarter after validating its performance, permitting its marketing throughout the European Community, Latin America, the Caribbean Basin, and other jurisdictions that accept the CE designation.

Jun 24, 2019

Agilent NovoCyte Advanteon Flow Cytometer

Agilent Technologies launched the NovoCyte Advanteon Flow Cytometer. It is the first product from Agilent's recently acquired ACEA Biosciences. the NovoCyte Advanteon can be configured with, two, or three lasers and up to 21 fluorescence channels. It also has a 7.2 log dynamic range, and fully automated compensation features.

Jun 24, 2019

Cytek Biosciences Five-Laser Flow Cytometer

Cytek Biosciences launched the latest version of the Cytek Aurora advanced flow cytometry system, now available with five lasers to allow users to see more than 30 colors from a single sample. Among the features of the new instrument is that no optical filters need to be changed and any fluorochrome excited by the onboard lasers can be used. Sensitivity is improved as is resolution of dim and rare populations, Cytek added. 
Jun 19, 2019

Proscia's DermAI Digital Pathology Application

Proscia has launched DermAI, its first in a series of artificial intelligence applications for pathologists. DermAI, a module on the firm's Concentriq digital platform, uses deep learning to prescreen and classify skin biopsies, aiming to help reduce diagnostic errors and improve laboratory quality and efficiency, Proscia said. The artificial intelligence application reads and automatically classifies hundreds of variants of skin diseases into prediagnostic categories.

Jun 18, 2019

Biocept NGS Breast Panel

Biocept has launched its second multi-gene liquid biopsy product, the Target Selector NGS Breast Panel, which is run on Thermo Fisher Scientific's Ion Torrent next generation sequencing platform and is designed to enable the detection and monitoring of actionable genomic biomarkers associated with breast cancer. The company said the test, which will be marketed to physicians and researchers, has shown over 99 percent sensitivity with at least 90 percent specificity in internal validations. 

Jun 17, 2019

Abbott Afinion HbA1c Dx Assay

Abbott announced that its Afinion HbA1c Dx assay is available for use on its Afinion 2 and Afinion AS100 analyzers. The Afinion HbA1c Dx assay is the first rapid point-of-care test cleared by the US Food and Drug Administration (FDA) to aid healthcare professionals in the diagnosis of diabetes and the assessment of patients' risk of developing the condition, Abbott said.

The test delivers accurate and precise HbA1c results in three minutes, enabling clinicians to diagnose patients and help them formulate individualized care plans during a single doctor's office visit, the firm said.

Jun 12, 2019

Patients Choice Laboratories UTI+ Test

Patients Choice Laboratories has launched the UTI+ molecular test for urinary tract infections. The Indianapolis-based company said the new test is part of its goal to be a full-service lab. It added that its gene- and molecular-based technologies provides uropathogenic and antibiotic resistance testing results within six hours after specimen receipt compared to up to three days with urinalysis by culturing. 

Jun 04, 2019

Illumina VeriSeq NIPT Solution v2

Illumina has launched the VeriSeq NIPT Solution v2, a CE-IVD, next-generation sequencing-based approach to noninvasive prenatal testing. The new version expands the range of chromosomal and sub-chromosomal conditions associated with birth defects that laboratories can screen for. The assay provides information about fetal chromosomal status as early as 10 weeks of gestation using a single maternal blood draw, and provides an option to screen for aneuploidy in all autosomes, chromosomes X & Y, and partial deletions and duplications greater than 7 Mb across the genome. It is available in Europe and South Africa; registration is pending in Australia, Israel, and New Zealand.

May 28, 2019

Bio-Rad Laboratories D-100 Hemoglobin Testing System

Bio-Rad Laboratories has launched the D-100 Hemoglobin Testing System for total laboratory automation. The company said it is connecting the sytem to track systems for optimized HbA1c workflow. The D-100 Hemoglobin Testing System now has point-in-space pipetting capability allowing integration with total lab automation systems for direct aspiration of samples as they move along the track. Bio-Rad noted it can connect with Inpeco FlexLab automation systems. 

May 28, 2019

Roche Ventana ROS1 Rabbit Monoclonal Primary Antibody

Roche launched the Ventana ROS1 rabbit monoclonal primary antibody, which the company said is the first and only in vitro diagnostic ROS1 immunhistochemistry assay. The test detects the presence of ROS1 protein in tisuue and may be used to identify ROS1-positive cancer in patients. College of American Pathologists and National Comprehensive Cancer Network guideliness recommend ROS1 testing for confirmed lung adenomcarcinoma cases, Roche noted. The test is a US class I/CE IVD device and can be used with Roche's BenchMark series of automated staining instruments. 

May 17, 2019

BioReference Laboratories Aerobic Vaginitis Testing

BioReference Laboratories and its specialty women’s health division, GenPath, launched new testing for aerobic vaginitis, a vaginal infection caused by the overgrowth of aerobic bacteria that triggers an inflammatory response.

Aerobic vaginitis occurs with bacterial vaginosis in 36.9 percent of vaginal discomfort cases, but they are separate infections.

While similar, they require different treatment regimes, BioReference said. If untreated, complications of aerobic vaginitis include an increased risk for contracting sexually transmitted infections, pelvic inflammatory disease, infertility, premature labor, preterm delivery, and premature rupture of membranes.

May 16, 2019

Siemens Healthineers Hemoglobin A1c Test on Atellica Solution

Siemens Healthineers announced the global availability of its new Atellica CH Enzymatic Hemoglobin A1c (A1c_E) Assay to assist clinicians in diagnosing and monitoring diabetes.

The firm said that demands will continue to grow on laboratories for screening and monitoring as the diabetic population continues to expand. It noted that instruments with higher throughput capabilities offer laboratories the ability to run a greater volume of tests and produce patient results more quickly, and laboratories are seeking HbA1c assays that can be integrated onto chemistry testing platforms. The Atellica CH Enzymatic Hemoglobin A1c Assay offers these capabilities, Siemens said.

May 14, 2019

Primerdesign Genesig q32

Primerdesign, the molecular business of Novacyt, has launched a next-generation molecular testing instrument called Genesig q32. The new qPCR instrument is larger than the firm's Genesig q16 instrument and provides customers with a faster, higher throughput solution for using Novacyt's genesig real-time PCR kits. The q32 provides test results within 60 minutes using Genesig kits, processing up to 32 patient samples in tube or strip format with fluorescence detection technologies.

May 02, 2019

Proscia Concentriq

Proscia has released the latest update of its Concentriq digital pathology platform. Improvements include a new performance analytics module in addition to a new suite of automation features. The features include a metrics dashboard, intelligence workload balancing, automated trigger-based notifications and alerts, and automted case actions. 

May 01, 2019

Arc Bio Galileo Pathogen Solution, GPS-Transplant

Arc Bio has launched the Galileo Pathogen Solution product line and first product, GPS-Transplant, a research-use-only next-generation sequencing test to aid in monitoring post-transplant patients for viral infections. GPS-Transplant detects the most common viral infections among transplant patients, including cytomegalovirus, Epstein–Barr virus, BK virus, and human adenovirus. The test also detects different variances and genotypes of the viruses, as well as more rare infections. GPS-Transplant also offers the ability to detect antiviral resistance mutations, and performs simultaneous quantitative detection of more than 350 viral strains. It is a sample-to-report solution built around the Illumina NGS platform that consists of reagents, built-in assay controls, and Galileo Analytics, a cloud-based proprietary software that provides quick and reliable results, an intuitive user interface, and detailed, actionable reports. The analytics software leverages Arc Bio's curated pathogen database called ArcIve, and also incorporates AMR resistance prediction technology which Arc Bio launched last year.

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 group said that it is the first commercially available molecular test for P. vivax-associated malaria. The assay 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. According to the group, the assay's 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. 

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