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Mar 20, 2020

Asuragen Armored RNA Quant SARS-CoV-2 Control

Asuragen is offering an Armored RNA Quant SARS-CoV-2 Control for use in developing assays in response to the COVID-19 pandemic. The new control material targets the SARS-CoV-2 viral nucleocapsid region and, along with the company's new RNAse P construct, aligns with the US Centers for Disease Control and Prevention- and World Health Organization-recommended diagnostic panel. Asuragen said that armored technology encapsulates the in vitro transcribed RNA in a protective protein coat to resist nuclease degradation, enabling its use as RNA extraction, process quality, and positive diagnostic reference controls.

Mar 20, 2020

LGC SeraCare AccuPlex SARS-CoV-2 Reference Material Kit

LGC SeraCare recently launched the AccuPlex SARS-CoV-2 Reference Material Kit, which contains positive reference material targeting the published US Centers for Disease Control and Prevention and World Health Organization consensus sequences, as well as complementary negative reference material targeting the human RNAse P gene. LGC SeraCare said that its kit is superior to "naked" transcribed RNA which does not evaluate the assay extraction step, and safer than heat-treated infectious samples, and are a valuable tool for clinical laboratories seeking to perform assay installation, verification, and performance monitoring.

Mar 17, 2020

CareDx RemoTraC

To address the concerns of the immunosuppressed transplant community to the COVID-19 pandemic, CareDx has launched RemoTraC, a solution enabling remote home-based monitoring of transplant patients. RemoTraC is a remote home-based blood draw product that uses mobile phlebotomy for AlloSure and AlloMap surveillance tests, as well as for other standard monitoring tests.

RemoTraC will be offered to all patients who want their transplant monitoring lab tests to be drawn at home by trained mobile phlebotomists, CareDx said. The company has built a national network of blood draw options for the transplant community. Patients can register through the web.

Mar 13, 2020

Bio-Rad Exact Diagnostics SARS CoV-2 Standard

Bio-Rad has launched a standard for SARS-CoV-2 testing through its Exact Diagnostics product line. The standard contains synthetic RNA transcripts of the virus as well as human genomic DNA, enabling labs to test the entire process of a molecular assay, including extraction, amplification, and detection of the virus.

Mar 13, 2020

Microbiologics Synthetic RNA for SARS-CoV-2

Microbiologics is now offering synthetic RNA for SARS-CoV-2 to assist in the efforts to monitor the spread of COVID-19. The material mimics the viral nucleic acid and provides the exact targets specified by the US Centers for Disease Control and Prevention for test development, the company said.

Specifically, it is a 1,044-nucleotide RNA specific for the SARS-CoV-2 N (nucleocapsid) gene. It contains all three markers (N1, N2 and N3) detected by the CDC Real-Time RT PCR Panel for detection of 2019 novel coronavirus. The RNA material assists in the development of diagnostic assays and the evaluation of the performance of nucleic acid tests for determination of the presence of SARS-COV-2.

The RNA is available in two different concentrations: 1x106 and 1x109 genome copies per tube. The material can be shipped within the USA without handling restrictions or permitting requirements. The company noted that permits may be required outside the USA and interested parties should check with local authorities.

Mar 12, 2020

Twist Bioscience Synthetic SARS-CoV-2 RNA Controls

Twist Bioscience has made two synthetic SARS-CoV-2 RNA controls available for use in quality control in the development and validation of next-generation sequencing- and reverse-transcription PCR-based tests.

The sequence-verified controls are designed to cover the full viral genome of two specific virus variants: MN908947.3, considered the reference genome, isolated from a patient in Wuhan, China, and MT007544.1, isolated from a patient in Australia.

Twist noted that customers purchasing synthetic controls are subject to the firm's biosecurity screening protocols.

Mar 11, 2020

ZeptoMetrix NATtrol SARS-CoV-2 Recombinant Construct

ZeptoMetrix has released its newly inactivated and non-infectious NATtrol SARS-CoV-2 Recombinant construct for laboratory quality control and test validation.

This non-infectious quality control incorporates a recombinant construct associated with targeted detection regions of the virus that may be used in the development of molecular assays designed to detect SARS-CoV-2. It can also be used in BSL-2 facilities in place of the live virus, as non-infectious, external quality controls for assays developed to detect SARS-CoV-2, the company said.

Mar 10, 2020

Instrumentation Laboratory GEM Premier ChemStat IVD Analyzer

Instrumentation Laboratory has launched its GEM Premier ChemStat in vitro diagnostic analyzer with Intelligent Quality Management (iQM) in the US. The whole-blood analzyer is designed for rapid metabolic panel testing at the point of care, primarily in hospital emegency departments and clinical laboratories, and provides laboratory-quality results on demand in less than 70 seconds from venous or arterial lithium-heparinized, whole-blood samples. iQM provides information about the quality of each sample and automatically detects, corrects, and documents any action the system performs, ensuring test quality and supporting immediate patient management decisions. 

Mar 10, 2020

Thermo Fisher Cascadion SM 25-OH Vitamin D Assay

Thermo Fisher announced its Cascadion SM Clinical Analyzer is commercially available in the US with the Cascadion SM 25-Hydroxy Vitamin D assay. The serum assay reports total vitamin D results alongside its components and is designed to deliver measurements of vitamin D2 (ergocalciferol) and D3 (cholecalciferol). The test incorporates fully barcoded components, and the calibrators and controls are traceable according to the National Institute of Standards and Technology. Assay calibration remains stable for up to 30 days, the company said. Both the analyzer and the assay were listed with the US Food and Drug Administration on Feb. 28, 2020. The analyzer is listed as a Class I instrument, and the assay is listed as Class II exempt with special controls. 

Mar 04, 2020

Biodesix, Oncimmune EarlyCDT Lung

Biodesix has commercially launched Oncimmune's EarlyCDT Lung test in the US, under a commercialization agreement the two firms announced last year. Marketed under Biodesix's Nodify Lung brand, the new Nodify CDT test is designed to assist physicians to identify patients with lung nodules at high risk of lung cancer.

The assay joins Biodesix's existing Notify XL2 test for low-risk lung nodule detection, and, according to Oncimmune, both tests will now be offered together as the Nodify Lung Nodule Risk Assessment strategy, with physicians able to order the two assays from a single blood draw.

Feb 26, 2020

Meridian Bioscience Air-Dryable qPCR Mix

Meridian Bioscience announced its Air-Dryable qPCR mix, a specialized master mix with a magnesium-containing formulation allowing air or oven drying protocols for ambient temperature-stable real-time PCR assays. The mix allows dry down and test stability at ambient temperature, eliminating the need for cold chain storage, the company said. It shows high performance in multiplex reactions following rehydration, which Meridian said makes it suited for automated high-throughput platforms. 

Feb 25, 2020

Blueprint Genetics Mitochondrial Genome Analysis

Blueprint Genetics, a Quest Diagnostics company, has introduced full mitochondrial genome DNA (mtDNA) analysis to its diagnostic panels to increase diagnostic potential across medical specialties such as cardiology, metabolic disease, neurology, ophthalmology, and hearing loss. The analysis uses hybridization-based capture of mtDNA and next-generation sequencing to detect low heteroplasmy levels of mtDNA SNVs, indels, and deletions. It includes sequencing and copy number variant analysis of the entire mitochondrial genome (37 genes) which can be ordered alone or added to any panel. It has also been added to 30 existing panels where mitochondrial DNA testing is expected to have an impact on the diagnostic potential.

Feb 21, 2020

Bio-Rad Laboratories EDX RP Positive Run Control

Bio-Rad Laboratories said that Exact Diagnostics has launched the EDX RP Positive Run Control, an unassayed external quality control for monitoring the performance of clinical respiratory assays. Bio-Rad acquired Exact Dx in the third quarter of 2019. Routine use of the EDX RP Positive Run Control allows labs to meet their individualized quality control goals, such as the evaluation of reagent lot changes and new shipments, Bio-Rad said. The control also monitors multiple identical devices and provides an evaluation of different personnel and locations. It contains 22 respiratory analytes that are internally value-assigned using Bio-Rads Digital Droplet PCR technology and is designed to test the entire process of a molecular assay, including extraction, detection, and amplification. 

Feb 06, 2020

CeGaT Exome Xtra

CeGaT has launched the CeGaT Exome Xtra test, which the firm says increases the diagnostic yield compared to a standard exome test. Besides coding sequences, it includes all medically relevant regions throughout the genome, such as pathogenic and likely pathogenic intronic variants, disease-associated transcripts, cryptic exons, as well as the mitochondrial genome. In addition, the data analysis considers variants in genes with reduced penetrance, variable expressivity, imprinting effects, and SNV/CNV combinations.

Feb 06, 2020

Thermo Fisher Scientific Ion Torrent CarrierSeq ECS Kit

Thermo Fisher Scientific has introduced the Ion Torrent CarrierSeq ECS Kit for expanded carrier screening. The AmpliSeq-based panel, which runs on the Ion GeneStudio S5 sequencer, covers 420 genes, including difficult-to-sequence ones like SMN1 and SMN2 for spinal muscular atrophy, GBA for Gaucher disease, CYP21A2 for 21-hydroxylase deficient congenital adrenal hyperplasia, and HBA1 and HBA2 for alpha thalassemia. It detects more than 28,000 non-benign ClinVar variants, including single nucleotide variants and copy number variants, and comes with customizable Carrier Reporter software.

Feb 05, 2020

Hologic Panther Scalable Solutions

Hologic launched new products in the US and Europe within its Panther Scalable Solutions portfolio, in which the firm's molecular diagnostic Panther system functions as the foundation for optional add-ons. The add-on components include Panther Fusion, which launched in 2016 and provides additional IVD menu and an Open Access functionality; Panther Plus and Panther Link, which are now available; and Panther Trax, which is in development.

With Panther Plus, labs can load more consumables directly on the instrument, allowing up to 13.5 consecutive hours of walk-away time. Panther Link is a software solution that provides additional efficiencies by creating a virtual connection that allows multiple Panther instruments to communicate with one another and function within a singular, streamlined workflow. Panther Trax is being developed to physically and electronically link multiple Panther instruments into a single workcell.

Feb 05, 2020

Bio-Techne Next-Generation ELISA Kits

Bio-Techne has launched its Quantikine QuicKit next-generation ELISA product line, which expands the capabilities of its legacy Quantikine ELISA kits. According to Bio-Techne, the kit enables researchers to accomplish more in their day without compromising quality. It enables quantitation of proteins in serum, plasma, and cell supernates in 90 minutes.

Feb 03, 2020

Beckman Coulter Life Sciences DxFlex

Beckman Coulter Life Sciences has launched its DxFlex 13-color clinical flow cytometry system. The system uses avalanche photodiode technology to create a highly sensitive semiconductor electronic device to convert light to electricity, which the company said addresses the limitations of traditional photomultiplier tube-based flow cytometers and reduces compensation spillover. The system will be marketed in Europe and will be available in countries that accept the CE mark. 

Jan 29, 2020

NIPD Genetics Veragene

NIPD Genetics has expanded its Veragene noninvasive prenatal test. The new version of the assay, which covers aneuploidies, microdeletions, and monogenic diseases, is able to identify 2,000 mutations in 99 genes involved in 100 monogenic autosomal recessive and X-linked disorders.  

Jan 27, 2020

Agilent SureSelect XT HS2 DNA Kit

Agilent Technologies has launched its SureSelect XT HS2 DNA kit, which it said will offer researchers a complete solution to choose workflow options. The firm said the kit allows users to multiplex hundreds of samples in one sequencing run, remove sample contamination by indexing from reads, and improve error correction to detect variants with low allele frequencies. 

Jan 23, 2020

Meridian Bioscience High-Specificity Pfu HS Mix

Meridian Bioscience launched a High-Specificity Pfu Hs Mix to provide high-fidelity amplification for companion diagnostic and clinical testing. The solution cuts down on the possibility of uneven amplification of diverse types of sequences. Meridian said the mix has "market-leading" properties in terms of inhibitor resistance, multiplexing, and low GC bias and can be used in next-generation sequencing and PCR applications. 

Jan 14, 2020

Biocept Target Selector for CSF

Biocept's Target Selector liquid biopsy assays are now available to physicians to evaluate patients' cerebrospinal fluid for the presence of circulating tumor cells and biomarkers for patients with breast or lung cancer suspected of brain or central nervous system metastases. The presences of such cells may indicate brain metastases. Biocept said that up to 30 percent of patients with breast cancer and up to 36 percent of patients with lung cancer will develop brain metastases.  

Jan 13, 2020

Bio-Rad Laboratories SEQuoia

Bio-Rad Laboratories announced the launch of the SEQuoia Complete Stranded RNA Library Prep Kit for RNA-Seq library preparation. The kit uses SEQzyme, an enzyme that couples cDNA synthesis with adapter addition in a continuous synthesis reaction. It is compatible with a broad range of sample inputs and allows capture of the complete transcriptome, including short and long RNAs, in a single library prep. The kit generates cDNA libraries suitable for strand-specific next-generation sequencing on Illumina sequencers in less than four hours. It also includes access to the integrated SeqSense analysis solution to process and quality control sequencing data for all RNA biotypes in the library within a single analysis pipeline.

Jan 13, 2020

OncoCyte DetermaRx

OncoCyte has launched the DetermaRx, test for identifying early-stage lung cancer patients who may benefit from adjuvant chemotherapy after surgical resection. The test was formerly known as the Razor treatment stratification test and was being developed by Razor Genomics, which OncoCyte acquired in September. Regulators in Canada have approved the test for marketing in that country, the Irvine, California-based firm said. In the US, Florida Precision Oncology and the Leonard Cancer Institute at Mission Hospital in Mission Viejo, California have signed up as early access users of the test, OncoCyte said. It said that in a clinical study, high-risk patients identified by the test post-surgery and treated with adjuvant chemotherapy had a "significant" increase in survival rates. 

Jan 13, 2020

Sphingotec: IB10 Sphingotest PenKit

SphingoTec has launched its IB10 sphingotest penKit. The CE-IVD-marked point-of-care test for proenkephalin allows for the real-time assessment of kidney function with a blood test. The test will be made available in Europe and other geographies that accept CE-IVD certification at the end of this month to the critical care community for further clinical evaluation. It will be available for use with Sphingotec's rapid POC platform, the Nexus IB10 that uses whole-blood samples without preprocessing, requires less than three minutes of hand-on time, and delivers test results in 20 minutes. 

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