New Products

Aug 02, 2018

MagArray Reveal

MagArray has launched its Reveal blood-based test for assessing lung cancer risk in current smokers. Reveal is based on magnetic nanosenor technology that was developed by Stanford University professor and MagArray Cofounder Shan X. Wang. The test is designed to help pulmonologists identify lung nodules with a higher probability of being benign and avoiding costly and invasive procedures. 

Aug 01, 2018

Beckman Coulter DxM MicroScan WalkAway System

Beckman Coulter launched the DxM MicroScan WalkAway system for bacterial identification and antibiotic susceptibility testing for microbiology labs. The system uses direct minimum inhibitory concentrations to detect antimicrobial resistance, and according to Beckman Coulter, it reduces costs associated with confirmatory testing. Newly added workflow enhancements include new fluid-level sensing technology, easy-to-view external LED indicatiors, quick bottle release, and integrated reliability improvements. 

Jul 31, 2018

Beckman Coulter Clinical Flow Cytometry Solutions

Beckman Coulter Life Sciences launched a number of new clinical flow cytometry solutions at the American Association for Clinical Chemistry meeting in Chicago. They include the ClearLLab CaseBook 5C, a resource into complex pattern recognition for leukemia and certain lymphomas using the ClearLLab panel of reagents, which are preformulated in vitro diagnostic antibody cocktails.

Bcekman Coulter also launched an enhanced portfolio of single color CE-IVD and analyte-specific reagents, and DURA Innovations dry reagent technology, comprising unitized reagent assays for labs to simplify the sample preparation process. 

Jul 30, 2018

Sceix Topaz Prep Station, Vitamin D 200A Assay Kit

Sciex has launched the Topaz Prep Station and the Vitamin D 200A Assay kit. The Topz is an automated sample prep workstation for labs that need to manage high daily sample volumes. The station supports the Topaz LC-MS/MS System. 

The FDA-approved vitamin D kit is a locked, prevalidated assay that labs can use to run vitamin D analysis in house. it employs automated sample prep on the Topaz Prep Stateion. 

Jul 25, 2018

SeraCare AccuSpan HCV RNA Linearity Panel

SeraCare has expanded its AccuPlex line with the launch of the AccuSpan HCV RNA Linearity Panel. The eight-member panel has been qualified against World Health Organization standards and is made from serial dilutions of high-titer recombinant hepatitis C virus, genotype 1b, with established reactivity for HCV RNA, and one negative control. The panel can be used by researchers, diagnostics manufacturers, and clinical labs to develop, evaluate, and validate HCV molecular test methods. The panel is useful for monitoring HCV RNA recovery at defined intervals, identifying consistency over a linear range, assessing lot-to-lot variability of kits, performing linearity studies, or any time there may be deterioration in diagnostic assays, according to the firm. It uses SeraCare's proprietary AccuPlex technology, which packages recombinant viral material in a way that is stable, replication-deficient, non-infectious, and mimics a real patient sample throughout the diagnostic workflow.

Jul 24, 2018

Microbiologics Molecular Diagnostics QC Panels

Microbiologics has launched new panels for the verification and routine quality control of common molecular assays. They include four panels for women's health and sexually transmitted infection testing: a human papillomavirus control panel; human papillomavirus verifcation panel; vaginal control panel; and vaginal verification panel. The company also launched new panels for blood culture identification and gastrointestinal testing: a blood culture control panel; blood culture verification panel; enteric viral control panel; and enteric viral verification panel. The new panels are designed to mimic patient sample processing, Microbiologics said. 

Jul 18, 2018

MNG Laboratories Comprehensive Intellectual Disability/Autism Panel

MNG Laboratories has added mitochondrial DNA sequencing and deletion analysis to its Comprehensive Intellectual Disability/Autism next-generation sequencing panel at no additional cost.

Jul 16, 2018

Ortho, Diazyme Assays For Diabetes, Cardiac, And Renal Diseases

In collaboration with Diazyme Laboratories, Ortho Clinical Diagnostics has launched glycated serum protein, lipoprotein (a), and cystatin C assays for use in the detection of diabetes, cardiac, and renal diseases on Ortho's Vitros 5600 Integrated System and Vitros 4600 Chemistry System.

The GSP assay expands Ortho's diabetes menu offering; lipoprotein (a) expands on its offering of diagnostic cardiac markers for patients who may have a genetic risk factor for premature cardiovascular disease; and the cystatin C assay tests for a key marker that enables early diagnosis of chronic kidney disease and complements serum creatinine testing, the firm said.

Ortho said that it is providing the assays to customers as part of its Microtip Partnership Assay program, which enables it to validate and offer high value, esoteric testing in step with the evolving needs of today's labs.

Ortho noted that the assays will initially be available in the US, Europe, Africa, and the Middle East.

Jul 13, 2018

Exosomics Siena SeleCTEV-DNA and SortEV-RNA

Exosomics Siena has launched its first proprietary liquid biopsy solutions, SeleCTEV-DNA and SortEV-RNA, which are both designed to aid selective isolation of tumor-derived nucleic acids from complex biofluids such as plasma or serum.

Unlike most liquid biopsy methods where total nucleic acids are harvested from blood Exosomics Siena's technology is based on the isolation and enrichment of tumor-derived exosomes. The new kits use unique affinity methods to select exosomes from which the DNA or RNA, respectively, can be extracted. Additionally, the SeleCTEV-DNA kit can be used to isolate circulating cell-free DNA in addition to DNA borne by exosomes.

Both tools are currently for research use only.

Jul 12, 2018

Sight Diagnostics OLO

Sight Diagnostics this week announced it had launched a complete blood count test on its point-of-care device, called OLO, in Europe and non-US countries. OLO uses digital fluorescent microscopy and machine-learning algorithms to capture and analyze images of blood drawn from a finger prick. The system, which Sight developed for use in doctors' offices, analyzes 19 CBC parameters from less than 30 µL of blood and reports results in 10 minutes. 

Jul 12, 2018

Medical and Biological Laboratories MEBRIGHT NUDT15 Kit

Medical and Biological Laboratories of Japan has launched the MEBRIGHT NUDT15 kit for detecting genetic polymorphisms in the NUDT15 (Nudix Hydrolase 15) gene, which can predict serious side effects of thiopurine drugs.

Thiopurine drugs are often prescribed to patients with inflammatory bowel disease, leukemia, rheumatic disease, or after an organ transplant, but clinical studies have shown that the drugs can induce adverse effects such as severe leukopenia and alopecia universalis within about eight weeks. A strong correlation has also been demonstrated between the development of serious adverse effects of thiopurine drugs and polymorphism in NUDT15, particularly among East Asians, Medical and Biological Laboratories said.

Using real-time PCR, the kit detects polymorphisms at codon 139 of NUDT15 in DNA from a patient's blood. The kit requires a processing time of two hours and simultaneously measures multiple samples, the firm said. The kit, which was jointly developed with Tohoku University, was approved as an in vitro diagnostic test by Japan's Pharmaceutical and Medical Device Agency in April.

Jul 06, 2018

Thermo Fisher Scientific Phadia 200

Thermo Fisher Scientific has released the Phadia 200, a benchtop instrument to test for allergies and autoimmunity conditions that quantifies clinically relevant antibodies in blood. The instrument, which is CE-marked and fully automated, can perform up to 700 different ImmunoCAP and EliA tests. It can process 42 samples at a time and provide up to 200 test results per day. The Phadia 200 is designed for smaller diagnostics facilities that want to increase their throughput and efficiency.

Jul 03, 2018

Devyser Thalassemia Kit

Devyser has released the Devyser Thalassemia kit for the analysis of sequence variants in the HBA1, HBA2, and HBB genes in human genomic DNA. Compatible with the Illumina MiSeq and MiniSeq instruments, the research-use-only kit detects all mutations in these genes including SNVs, indels, and copy number variations. The PCR chemistry provides complete and uniform coverage of targeted regions, and enables a high level of overlapping amplicon multiplexing and NGS library preparation with no sample splitting, the company said. 

Jun 28, 2018

Thermo Fisher Scientific Oncomine TCR Beta-SR Assay

Thermo Fisher Scientific has launched the Oncomine TCR Beta-SR Assay, a sequencing assay to characterize T-cell clonality in the tumor microenvironment. The test will interrogate the CDR3 region of the beta chain of the T-cell receptor, a region that is responsible for antigen recognition and helps to identify T-cell clones. The assay uses dual barcode indexing, which allows identification of low-frequency clones for potential tracking of minimal residual disease. It is optimized for formalin-fixed paraffin-embedded tissue, peripheral blood leukocytes, peripheral blood mononuclear cells, or cell-free DNA, and can work with either DNA or RNA as input.

Jun 27, 2018

Leica Biosystems Bond RX Stainer

Leica Biosystems launched its Bond RX stainer. The instrument has customization options across all protocol editing systems allowing greater flexibility when optimizing conditions for tests based on immunofluorescence, in situ hybridization, fluorescence in situ hybridization, terminal deoxynucleotidyl transferase dUTP nick end labeling, thermal shift assay, circulating tumor cell, multiplexing, and other emerging tests, Leica said. Features of the instrument include protocol customization advancements, a reagent visual management lighting system, and a new software version 6.0. 

Jun 25, 2018

Invitae Carrier Screen

Invitae has launched several genetic carrier screening products. The Invitae Comprehensive Carrier Screen uses next-generation sequencing to analyze 287 genes linked to serious genetic disorders and identifies more than 99 percent of disease-causing changes in most of the genes analyzed. In addition, the company offers a 46-gene test, called Invitae Broad Pan-Ethnic Carrier Screen, that assesses a smaller set of common disorders, and a test called Invitae Pan-Ethnic Carrier Screen that analyzes three genes associated with cystic fibrosis, spinal muscular atrophy, and fragile X syndrome. Both of the smaller panels can be supplemented with a customized set of genes from the large panel and with 13 genes not included in any pre-curated panel. The Invitae Carrier Screen replaces the GeneVu carrier screen from Good Start Genetics, which Invitae acquired last year.

Jun 19, 2018

GenomeDx Biosciences, Pathnostics Guidance test

GenomeDx Biosciences and Pathnostics have launched the Guidance test for patients with simple cystitis, recurrent, persistent or complicated urinary tract infections, prostatitis, and interstitial cystitis. The test is performed by Pathnostics and distributed by GenomeDx urologists. Guidance is a rapid diagnostics test for personalizing treatment options by identifying 42 pathogens. It also determines antibiotic sensitivity of the pathogens and assesses the presence of antibiotic-resistant genes. Result are available 24 to 48 hours after a patient's specimen arrives at the lab. 

Jun 14, 2018

Now Diagnostics First To Know Pregnancy Test

Now Diagnostics launched its over-the-counter First To Know finger-stick pregnancy test in Italy, making it the first OTC, blood-based pregnancy test for sale in the EU. The test is available in pharmacies in Italy through an exclusive distribution agreement with Welcome Pharma. Now Diagnostics CEO Gianni Furino said the company plans to expand the availability of First To Know throughout the EU in the coming months. The test is not US Food and Drug Administration-cleared for OTC sale or for home use in the US. 

Jun 14, 2018

Agilent In Situ Hybridization Probes

Agilent Technologies released a range of new probes for in situ hybridization. The probes address the need to cleanly and accurately interpret data from fluorescence in situ hybridization and chromogenic in situ hybridization, Agilent said. The new Agilent SureFISH probes include Break-Apart: MALT1, BCL2, BCL6, CCND1, MYC, IGH, Dual Fusion: IGH/CCND1, IGH/MYC, and IGH/BCL2. The new CISH probes include (ASR) EBER RNA CISH and Kappa and Lambda mRNA CISH probes.

Jun 12, 2018

Agilent Chromogenic In Situ Hybridization With Tumor Sample Staining

Agilent Technologies announced the release of a new accessory kit that enables the company’s fully automated Dako Omnis tumor sample staining system to analyze tissue samples using three different techniques simultaneously. With the new kit, the system can process immunohistochemical, fluorescence in situ hybridization, and chromogenic in situ hybridization assays. All tests for a specific case can be run simultaneously, and a clinician can get results in a "greatly reduced timeframe, enabling better patient case management," Agilent said.

Jun 11, 2018

Molecular Health Guide Version 3.0

Molecular Health has released version 3.0 of its Molecular Health Guide software platform for precision medicine. According to the company, the new release offers improved biomarker classification and now supports Human Genome Variation Society nomenclature, allowing users to incorporate other diagnostic test results into MH Guide reports, which combine patient-specific molecular data with biomedical knowledge to assist physicians in choosing treatments. MH Guide is registered as an in vitro diagnostic device in the European Union.

Jun 07, 2018

Curetis Unyvero System, Lower Respiratory Tract Infection Cartridge

Curetis has announced the US commercial launch of its molecular diagnostic Unyvero System and the Unyvero LRT Application Cartridge, a test cartridge to detect lower respiratory tract infections. The cartridge, which was cleared together with the system by the US Food and Drug Administration earlier this year, covers more than 90 percent of infection cases of hospitalized pneumonia patients, detecting pathogens and genetic resistance markers directly from aspirate samples in less than five hours.  

Jun 05, 2018

Grifols Daratumumab Neutralization Test

Grifols has added a daratumumab neutralization testing service to its menu offered at the Grifols Immunohematology Center laboratory in San Marcos, Texas. The test enables complete antibody screening and identification in pretransfusion testing of patients using daratumumab, a monoclonal antibody for the treatment of multiple myeloma. The test is based on a soluble recombinant human CD38 that neutralizes the therapy present in plasma and eliminates its interferences with routine pretransfusion testing, the company said. 

Jun 05, 2018

Novacyt Infectious Mononucleosis Immunoassay

Novacyt's protein diagnostics division, Lab21, has launched a new product for the diagnosis of infectious mononucleosis (IM), or glandular fever. The product, PathFlow Mononucleosis, is a qualitative lateral flow immunoassay for the detection of IM antibodies in the blood. IM is frequently misdiagnosed as streptococcal pharyngitis, a bacterial infection, due to common clinical presentation of the diseases at onset. However, Epstein–Barr, a virus, causes infectious mononucleosis, so it doesn't respond to antibiotic treatment. PathFlow Mononucleosis provides a rapid and effective differential diagnosis to patients with IM over streptococcal pharyngitis, Novacyt said.

Jun 04, 2018

OmniSeq Advance

Roswell Park Comprehensive Cancer Center subsidiary OmniSeq and the Laboratory Corporation of America have launched a molecular cancer assay, OmniSeq Advance. The test involves next-generation sequencing and immunohistochemistry to assess specific genomic alterations, tumor mutational burden, microsatellite instability, the tumor microenvironment, and markers associated with immunotherapy. LabCorp will distribute the test.

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