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NMDX HER-2/neu blood test kits

May 17, 2017

NMDX, a company spun off from now-defunct Nuclea Technologies, is now selling HER-2/neu blood testing kits, acquired from Nuclea. The test measures the presence of HER-2 protein for patients with metastatic breast cancer. 

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Mar 05, 2021

Promega XpressAmp Direct Amplification Reagents

Promega has launched automation-friendly reagents to facilitate RNA extraction-free sample preparation, called XpressAmp Direct Amplification Reagents. The reagents allow labs to skip the RNA extraction step of a typical PCR workflow. The process consists of 10-minute lysis step with XpressAmp Lysis Buffer followed by RT-qPCR containing XpressAmp Solution. 

Mar 05, 2021

Qiagen QiaSphere for QiaStat-Dx

Qiagen has launched its QiaSphere cloud-based platform that will allow labs and users of the company's QiaStat-Dx syndromic molecular testing platform to continually monitor tests and instrument status. The platform can monitor a nearly unlimited number of instruments, providing visibility of testing routines across different hospitals or satellite labs. Customers will be able to receive instrument and test status push notifications across their personal devices, and continuous connectivity will allow Qiagen technical service to monitor instrument health in real time, the company said. Qiagen began marketing and distributing QiaSphere for the QiaCube Connect platform in early 2021.

Feb 22, 2021

Verichem Laboratories' HDL Cholesterol Verifier Kit

Verichem Laboratories launched its HDL Cholesterol Verifier Kit, which is intended for the calibration verification of high density lipoprotein and low density lipoprotein cholesterol tests. The kit contains HDL and LDL cholesterol and other liquid components from human serum without interfering substances like surfactants, glycols, and azide. It also contains a blend of "highly purified" human serum albumin, human serum globulin, and bovine gamma globulin in saline, the company said.

Using purified source components eliminates matrix variations, allowing for lot-to-lot reproducibility and consistency, the company added. The HDL and LDL cholesterol targets are determined using reference method certified calibration materials, and the material's pH, matrix composition, and protein balance are kept constant. 

The kit comes with five milliliters of material at each concentration level and have shelf-life stability of 14 months when stored between -15 and -25 degrees Celsius. It can be frozen and thawed for up to 10 cycles.

Feb 19, 2021

Guardant Health Guardant Reveal

Guardant Health has launched Guardant Reveal, a blood-based liquid biopsy test for the detection of residual and recurrent disease in cancer patients. Intended initially for the early-stage colorectal cancer space, the assay detects circulating tumor DNA in patients' blood to identify those with residual disease who may benefit most from adjuvant therapy and/or detect the first signs of a recurrence. Results are returned in as little as seven days without the need for a tissue biopsy.

Feb 16, 2021

MedTrainer LabComply

Healthcare compliance management software developer MedTrainer has launched LabComply, a learning, compliance, and credentialing software package for managing CLIA and CLIA-waived testing. Redwood, California-based MedTrainer said that the technology helps healthcare organizations manage laboratory safety, administrative, and engineering controls, training, documentation, and reporting, including verification of standard operating procedures. The firm is marketing the product to long-term care facilities and other organizations that have had to install lab equipment to handle onsite COVID-19 testing, as well as to more traditional diagnostic labs.

Feb 09, 2021

Tempus xG

Tempus has launched a new germline sequencing assay, xG, a 52-gene panel that specifically identifies genetic variants associated with hereditary cancer syndromes and inherited risk of cancer. The test is performed by BioReference Laboratories' subsidiary GeneDx and joins Tempus' existing suite of oncology-focused testing offerings, including tumor and liquid biopsy tests, HRD, and TO (tumor of unknown origin) assays.

Feb 02, 2021

Myriad Genetics Vectra Cardiovascular Risk

Myriad Genetics has launched Vectra Cardiovascular Risk, a report that estimates rheumatoid arthritis patients' risk of heart attack, stroke, or cardiovascular event-related death in the next three years. Vectra DA is a blood test that measures inflammation caused by RA, but now also incorporates three additional biomarkers to calculate a cardiovascular risk score for RA patients. The risk categories — low, borderline, intermediate, and high —align with the American College of Cardiology and American Heart Association's cardiovascular risk thresholds.

Feb 02, 2021

LGC Maine Standards Validate HbA1c for Siemens Healthineers Atellica and Dimension Analyzers

LGC Maine Standards launched its Validate HbA1c test kits to meet the linearity and calibration verification needs of clinical laboratories running Siemens Healthineers Atellica or Dimension analyzers. The product, which includes the analyte Hemoglobin A1c, is formulated in a human, whole blood matrix using the CLSI EP06-A equal delta sample preparation method.

Jan 29, 2021

Beckman Coulter DxH 560 AL Hematology Analyzer

Beckman Coulter launched its tabletop DxH 560 AL hematology analyzer, which is intended to reduce time and resource constraints for smaller laboratories. The instrument has auto-loading functionality, closed tube aspiration, and walkaway capabilities, and users can continually add up to 50 samples. Results are provided in a minute or less, and the analyzer only requires 17 μL of blood, the company said. 

Jan 25, 2021

NIPD Genetics: Oreana Neonatal Genetic Screening Test

NIPD Genetics of Cyprus has launched Oreana, an expanded genetic screening test for newborns, infants, and children. The sequencing test screens for 106 genetic conditions in 142 genes, based on recommendations from the American College of Medical Genetic and Genomics. It requires a buccal swab and has a turnaround time of two to three weeks from sample receipt.

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.