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Qiagen QiaStat-Dx

Apr 23, 2018

Qiagen announced the European launch of the QiaStat-Dx platform during the European Congress of Clinical Microbiology and Infectious Diseases in Madrid. The company also launched the first test on the system, a 21-pathogen respiratory panel. QiaStat-Dx is a fully integrated and automated molecular testing system based on real-time PCR. It can detect up to 48 viral and bacterial targets simultaneously, enabled by microfluidic test casettes coupled with a six-wavelength optical sensor. There are also plans for the instrument to run immunoassays based on time-resolved fluorescence detection. The system, previously developed by StatDx as the DiagCore, received CE marking in January, prior to Qiagen's acquisition of StatDx.

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Jan 22, 2021

Tecan Fluent Mix, Pierce Workstation

Tecan has launched the Fluent Mix and Pierce Workstation to provide end-to-end automation for whole-blood pipetting in clinical environments. The new instrument configuration is intended to standardize preanalytical sample handling and mixing, and is part of an ongoing collaboration with Qiagen to optimize sample preparation for latent tuberculosis testing with Qiagen's QuantiFeron-TB Gold Plus assay.

The automated workflow features a Flexible Channel Arm equipped with Tecan Piercing Tips to aliquot whole blood samples directly from vacuum blood collection tubes or septum-capped tubes without the need for manual lid removal. This reduces the risk of laboratory staff coming into contact with infectious materials, and saves valuable time when performing tube-to-tube or tube-to-plate transfers and whole-blood assays. The workstation also features the newly developed Tecan Tube Rotator, which provides 360-degree tube mixing to maintain whole blood samples in suspension without hemolysis, and includes barcode scanning for both primary and secondary tubes to ensure full process traceability for clinical settings, Tecan said.

Jan 15, 2021

Twist Bioscience Synthetic RNA Controls for SARS-CoV-2 UK Variant

Twist Bioscience has begun shipping new synthetic RNA reference controls for SARS-CoV-2 that include the new variant strain of the virus (B1.1.7 lineage, variant under investigation VUI-202012/01) identified in the UK. As the new strain contains multiple mutations in the spike protein and other areas of the viral genome, some of the RT-PCR probes used widely in COVID-19 testing no longer detect the S gene that codes for the spike protein, which can lead to false negative test results. Synthetic controls for this specific mutation will enable test developers to update their testing protocols, Twist said.

Jan 13, 2021

Proteocyte AI: Steve Arless, Anthony Morlandt, Barrie Renick

Proteocyte AI has hired a new management team, including Steve Arless as its executive chairman. Additionally, Anthony Morlandt has been hired as the Toronto-based firm's CEO and Barrie Renick is its new CMO. Proteocyte AI has also formed a clinical advisory board comprising Eric Dierks, Rui Fernandes, Ian Witterick, Deepak Kademani, James Melville, Simon Young, and Diana Lin. The company is developing in vitro diagnostic tests to detect and risk-stratify an oral dysplasia lesion.

Jan 11, 2021

Roche Digital Pathology Image Analysis Algorithms

Roche said Monday that it has introduced two algorithms to automate analysis of digital pathology images for diagnosis of breast cancer on its uPath software system. The uPath HER2 (4B5) algorithm helps pathologists determine whether tumors contain HER2 cancer biomarkers, while the dual ISH analysis looks for HER2 gene amplification, according to the Swiss company. Both produce heatmaps to lead pathologists to "areas of interest" that might contain cells that can help physicians develop the most promising treatment plans.

Jan 08, 2021

Biocare Medical Fully Automated IVD Benchtop Platform

Biocare Medical launched Oncore Pro, its fully automated staining platform for immunohistochemistry (IHC) and in-situ hybridization (ISH) applications in the clinical laboratory.

Oncore Pro processes up to 36 slides in a single run and has the ability to perform independent protocols at each slide position for high-throughput slide processing. The system will enable diagnostics laboratories, both large and small, to maximize their sample-processing throughput with optimal turnaround time, the firm said.

Jan 04, 2021

Verichem Laboratories Clinical Reference Materials

Verichem Laboratories announced the availability of ready-to-use, liquid-stable clinical reference materials for the calibration and calibration verification of clinical testing systems. The products support overall quality control and CLIA compliance and are used to determine a clinical system’s bias to a true or known value. Further, the reference materials are used for the independent determination of test method accuracy, sensitivity, linearity, and reportable range. They address the needs of a variety of medical laboratory professionals, including those involved in routine laboratory testing, clinical research applications, and the development and manufacturing of in-vitro diagnostic products.

Jan 04, 2021

Bruker MBT Sepsityper Kit US IVD

Bruker has launched its US Food and Drug Administration-cleared MBT Sepsityper Kit US IVD for rapid microbial identification of more than 425 microorganisms from positive blood cultures on the company's MALDI Biotyper CA System.

The MBT Sepsityper Kit US IVD enables rapid, specific detection of many cases of bacteremia-induced sepsis to assist infectious disease specialists. The kit performs identification directly from positive blood cultures with a time-to-result of less than 30 minutes.

Dec 17, 2020

Autogen NeXTRACT 48

AutoGen has launched the NeXTRACT 48 platform for the rapid extraction of viral DNA and/or RNA from a variety of samples including viral transport media, universal viral transport, and sputum. NeXTRACT 48 is compatible with most COVID-19 real-time PCRs diagnostic kits, is compact and easily fits into a BSL2 environment, and can process 48 samples in 20 minutes or 800 samples or more per day, AutoGen said. The platform is ideal for labs looking to supplement COVID-19 viral RNA extractions or to add a back-up platform with a low capital investment and operating cost, with consumables costing less than $5 per sample, the Holliston, Massachusetts-based company said.

Dec 17, 2020

Personalis SHERPA, NEOPS

Personalis has launched its Systemic HLA Epitope Ranking Pan Algorithm (SHERPA) machine learning-based tool for identifying and characterizing cancer neoantigens, as well as its Neoantigen Presentation Score (NEOPS) for predicting  cancer immunotherapy response.

SHERPA assesses the potential MHC-binding affinity and stability of identified peptides, and incorporates features linked to antigen processing machinery and RNA abundance to produce a presentation rank for each detected peptide. The rank determines the relative likelihood of a given neoantigen being presented and undergoing immunosurveillance. Integrated into the firm's NeXT platform, the tool allows for the development of new neoantigen-based diagnostic biomarkers, such as its NEOPS biomarker, and neoantigen-targeting personalized cancer therapies.

Personalis' NEOPS combines the tumor genomic and immune-related analytics of the firm's NeXT platform to create a composite biomarker, that the firm believes can be more effective in predicting immunotherapy responses than other biomarkers.

NEOPS and SHERPA are the latest updates to the comprehensive suite of advanced analytical engines of the Personalis NeXT Platform for biopharmaceutical customers, the company said.

Dec 17, 2020

Invitae Exome Reanalysis

Invitae has begun offering customers of its exome sequencing service routine case-level reanalysis of their results every six months for a minimum of three years. This will ensure that patients' results are up to date based on the latest variant classification research. The reanalysis will be conducted by the company's team of genetics experts, who will utilize an artificial intelligence-powered diagnosis engine that Invitae garnered with the acqusition of Belgian firm Diploid, and a gene-phenotype database.

Dec 11, 2020

ATCC SARS-CoV-2 External Control Kit

ATCC has introduced a SARS-CoV-2 External Control Kit for clinical laboratories and test manufacturers. The new kit enables clinical laboratories to meet federal regulations stipulating that they assess the performance of their testing applications. The kit comprises a universal, full-process positive control (a heat-inactivated virus) and negative control (human cell line) that allow clinocal labs to verify and assess the quality of their molecular diagnostic assays.

Dec 08, 2020

LGC Maine Standards: Validate PTH

LGC Maine Standards has launched the Validate PTH for labs running the Roche Cobas platform and in need of verifying the linearity and calibration of their systems. Validate PTH includes the analyte parathyroid hormone and is formulated in a human serum matrix using the CLSI EP06-A "equal delta" sample preparation method. It provides five distinct concentrations across the claimed range of Roche's Cobas instrument. LGC Maine Standards said that in combination with calcium, magnesium, and phosphorous in Validate GCI and vitamin D in Validate VIT D, labs can challenge the reportable range of Roche Cobas bone-related assays. While supporting daily quality control, it can help fulfill quality control requirement, including analytical measurement range and reportable range for linearity and calibration verification under CLIA "88, CAP, COLA, JCAHO, JCI, and ISO 15189.  

Dec 07, 2020

Verichem Laboratories Tru-Zero Bilirubin Standard

Verichem Laboratories has made its Tru-Zero Bilirubin Standard available as part of the firm's total and direct standard materials. The assays have a verified concentration level of 0.0 mg/dL and is for verifying the calibration of total and direct bilirubin assays with various chemistry testing systems, including systems from Abbott Diagnostics, Advanced Instruments, Beckman Coulter, Roche Diangostics, and Siemens Healthineers, Verichem said.

Tru-Zero Bilirubin Standard incorporates a proprietary stabilization process, eliminating the need for azide, glycol, or surfactants, the company said, adding it features a refrigerated open-vial product stability claim of five days, and a shelf-life of 14 months when stored at 2 to 8 degrees Celsius.

Dec 03, 2020

Meridian Bioscience Air-Dryable RT-qPCR Mix

Meridian has launched its Air-Dryable RT-qPCR mix, a specialized master mix designed for air drying instead of lyophilization. The ready-to-use mix has ambient temperature stability and removes the need for cold chain shipping and storage, the company said. Its one-tube format chemistry contains all the reagents necessary for RT-qPCR, including magnesium, dNTP, and reverse transcriptase.

The mix is designed to simplify development, manufacturing, and storage of molecular tests, along with delivering fast detection of RNA targets, making the mix ideal for COVID-19 testing, the firm said. Meridian added that the mix has high performance in singleplex and multiplex reactions after rehydration.

Nov 17, 2020

GeneMatters Automation for Pioneer Telegenetics Platform and RISE Patient Engagement Tools

GeneMatters has added automation features to its Pioneer Telegenetics Platform and has launched RISE Patient Engagement Tools to support patients undergoing genetic testing and counseling.

The Pioneer Telegenetics Platform, available since 2017, is designed to integrate telehealth genetic counseling service delivery and patient management. The platform now includes several automation features designed to reduce administrative burden, provide real-time communication, and allow GeneMatters to quickly deploy custom workflows to meet partner needs.

The RISE (Reach, Inform, Support, and Educate) Patient Engagement Tools specifically support patients and can be used independently or as a complement to Pioneer, and will include modules for genetic care such as scheduling, patient triage, patient education, and results delivery.

Feb
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Sponsored by
Thermo Fisher Scientific

As the world continues to contend with coronavirus and a surge in the infection rate, labs are required to run more samples than ever before. 

Feb
24
Sponsored by
SCHOTT MINIFAB

Developing a fully integrated consumable cartridge for an automated diagnostic platform is a significant challenge. More challenging still is developing such a cartridge in response to a deadly global virus pandemic amid market uncertainty and extraordinary time constraints.