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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 22, 2020

Kurin: Don Canal

Blood culture collection firm Kurin has hired Don Canal for the newly created position of executive vice president of operations. According to his LinkedIn profile, Canal was most recently a medical device consultant. Before that he was VP of operations and regulatory affairs and quality assurance at Ivera Medical.

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. 

Jan 09, 2020

Personalis NeXT Dx Test

Personalis has launchedthe NeXT Dx Test, a next-generation sequencing panel designed to help oncologists identify potential therapies and clinical trial options for cancer patients. The assay analyzes approximately 20,000 genes in both the tumor exome and transcriptome, and includes advanced analytics to provide a diagnostic report on genetic alterations in medically important cancer genes, as well as emerging immunotherapy-related biomarkers such as microsatellite instability status and tumor mutational burden.

Jan 08, 2020

Viracor Eurofins 'Viracor TRAC'

Viracor Eurofins has begun offering its Viracor TRAC donor-derived, cell-free DNA assay for diagnosing kidney transplant rejection. The noninvasive liquid biopsy test has similar characteristics to other donor-derived cfDNA assays on the market, Viracor Eurofins said. Two ongoing prospective and one retrospective clinical trials are underway to further develop clinical data to support use of the test. The current gold standard for diagnosing kidney transplant rejection and surveillance is organ biopsy, which is both expensive and can lead to multiple complications for the patient, the firm noted. 

Jan 07, 2020

PreventionGenetics Rapid PGxome WES Test

PreventionGenetics has added the Rapid PGxome whole-exome sequencing test to its clinical testing menu. It is ideal for situations where a rapid genetic diagnosis is essential, including patients with neonatal, infantile,  or early childhood onset severe disorders, the company noted. Rapid PGxome starts at $2,290 per test and must be ordered by a qualified healthcare provider. It has a turnaround time of 14 days and, in cases with a clear positive result, a preliminary report may be issued in as few as six days.

Jan 06, 2020

Sysmex Ipsogen JAK2 DX

Sysmex has launched the ipsogen JAK2 DX reagent after the product received health insurance coverage in Japan on Jan. 1. The Kobe, Japan-based firm said that it received marketing approval for the gene testing kit that measures the JAK2V617F mutation quantitatively in December 2018. The test is used to diagnose certain hematopoietic tumors, specifically polycythemia vera, essential thrombocythemia, and primary myelofibrosis. Sysmex inked a distribution deal with Ipsogen (now part of Qiagen) in 2011 covering Japan that allows Sysmex to distribute some Ipsogen blood cancer products in that country.

Dec 16, 2019

SpeeDx: ResistancePlus MG FleXible

SpeeDx has launched the ResistancePlus MG FleXible for the GeneXpert System in Europe. The test detects Mycoplasma genitalium and markers associated with azithromycin resistance. It is now available in France and the UK, to be followed by the rest of the EU, Australia, and New Zealand. Cepheid is the exclusive distribution partner of the test through its FleXible Cartridge program for the GeneXpert System.

Dec 16, 2019

Anixa Biosciences Cchek Prostate Cancer Confirmation Test

Anixa Biosciences launched its Cchek Prostate Cancer Confirmation test, which leverages the firm's AI- and flow cytometry-based liquid biopsy platform. The Cchek PCC test will be offered as a CLIA-validated test through Anixa's partner laboratory, ResearchDx, which validated it. The test, which uses a blood draw, is meant to confirm the need for prostate biopsy by measuring a patient's immunological response to malignancy by analyzing immune system cells in peripheral blood.

Dec 09, 2019

ELITechGroup Macroduct Advanced Sweat Collection System

In vitro diagnostic equipment and reagent company ELITechGroup has launched its Macroduct Advanced Sweat Collection System in Canada. The system further standardizes pilocarpine iontophoresis and sweat collection and has a touch screen interface with step-by-step graphical instructions, the company said. The new system also has revised electrode shapes to make it easier to work with neonates and toddlers. 

The company's other products include the Webster Sweat Inducer and the Macroduct Sweat Collection System. 

Dec 04, 2019

Quadrant Biosciences Clarifi ASD

Quadrant Biosciences has launched Clarifi ASD, an epigenetic test designed to aid in the diagnosis of autism spectrum disorder in children 18 months through six year of age. Quadrant said the test is based on regulatory RNAs and microbes in the saliva, and is the result of seven years of research in collaboration with SUNY Upstate Medical University and Penn State College of Medicine. Clarifi is a prescription-only, laboratory-developed test that is intended to be used as an additional tool to standard practices and only for children with a clinical suspicion of ASD, the company said. It is available in all states except New York.

Dec 02, 2019

Versiti P-Selectin Expression Assay for Heparin-Induced Thrombocytopenia

Versiti has launched its P-Selectin Expression Assay (PEA) for testing patients suspected of having heparin-induced thrombocytopenia (HIT).

HIT is an immune-mediated drug interaction that is difficult to diagnose. When left untreated, it can progress to thrombosis, the development or growth of blood clots within a blood vessel.

Compared to a current test for detecting HIT, the serotonin release assay, the PEA can detect more patients with HIT antibodies, Versiti said. Its PEA test has a turnaround time of less than 24 hours.

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