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Apr 12, 2021

Interpace Pharma Solutions: RNAscope ISH

Interpace Pharma solutions, a subsidiary of Interpace Biosciences has launched its RNAscope in situ hybridization (ISH) assay. The firm said RNAscope ISH uses "double Z" probes that simultaneously offer signal amplification and background noise control. Single-molecule visualization of the assay produces quantitative RNA expression and cell-specific expression with tissue architecture. The firm said that RNAscope ISH can streamline immune checkpoint target identification, visualize in vivo delivery of CAR-T therapeutic products, and distinguish therapeutic gene sequence from endogenous transcripts selection. 

Apr 01, 2021

MatMaCorp MY Real-Time Analyzer

Lincoln, Nebraska-based Materials and Machines Corporation, also known as MatMaCorp, has launched a rapid handheld molecular testing instrument called MY Real-Time Analyzer, or MYRTA, that performs PCR amplification or isothermal amplification and simultaneous real-time fluorescence detection. The device weighs less than one pound, can be held in one hand during operation, and can detect DNA or RNA targets within one hour, according to MatMaCorp. MYRTA can also process one sample with up to three different tests, and provides near quantitative information, including a Ct value.

Mar 31, 2021

OptraScan, OS-Ultra 320 High-Speed Digital Pathology Scanner

Digital pathology firm OptraScan has launched the OS-Ultra 320 high-speed digital pathology scanner. The instrument scans tissues and cells of 15 x 15 mm at 40x magnification in under a minute and features no-touch continuous loading operation. The San Jose, California-based firm noted the OS-Ultra 320 has been developed to reduce workflow errors and scale up pathology laboratory operations.

Mar 30, 2021

Beckman Coulter SuperNova Polymer Dyes

Beckman Coulter Life Sciences launched its SuperNova polymer dyes for flow cytometry that offer increased brightness when excited by the violet laser for their respective channel, allowing for clearer differentiation between positive and negative results for dimly expressed markers. The dyes also have an improved staining index through a proprietary formulation using unique additives to minimize non-specific staining for clearer results. They can help eliminate false positives and reduce re-testing due to unclear results, the company said.

Mar 23, 2021

Biocartis Idylla GeneFusion Assay

Biocartis has launched its Idylla GeneFusion Assay. The firm said the research-use-only test analyzes a wide range of biomarkers covering all gene fusions considered to be relevant in cancer research, including ALK, ROS1, RET, NTRK1/2/3 fusions, and MET exon 14 skipping mutations. Biocartis' test, which produces results within three hours, is the first formalin-fixed, paraffin-embedded RNA-based assay on Biocartis' Idylla platform. 

Mar 19, 2021

Grifols: Promonitor Quick Immunoassays

Grifols has launched a two-test point-of-care system to monitor levels of infliximab, a medication used to treat a variety of chronic inflammatory conditions. The rapid POC tests, part of Grifols' Promonitor Quick immunoassays, deliver results in 20 minutes using a fingerstick of whole blood. Promonitor Quick leverages lateral flow immunochromatography and eliminates pre-analytical sample processing. It is portable and enables clinicians and laboratory staff to measure levels of infliximab or detect its antibodies. Results appear on a reader while the patient waits, enabling easy optimization of treatment doses, Grifols said.

Mar 18, 2021

Roche Discovery Green HRP Kit

Roche has launched its Discovery Green HRP kit for research use only, a chromogen detection kit that can be used with other detection kits to expand the multiplexing capability of immunohistochemistry and in situ hybridization. It provides a distinct color that contrasts with other chromagens and complements other chromagens, including Discovery Yellow, Discovery Red, Discovery Purple, and Discovery Teal, to multiplex up to seven biomarkers simultaneously. 

The chromagens have translucent properties so researchers can analyze the co-localization of multiple biomarkers through the spatial overlapping of two signals in the context of tissue, Roche said. The kit can be fully automated on the Discovery Ultra system. 

Mar 17, 2021

Quest Diagnostics: At-Home FIT

Quest Diagnostics this week launched its at-home collection fecal immunochemical test, which is used to screen for colorectal cancer in stool samples. If blood is found in the sample, further screening and evaluation, such as a colonoscopy, will be recommended. Patients using the test, offered through the QuestDirect business, will be sent a collection kit via FedEx along with a prepaid FedEx shipping label and envelope by which the sample can be sent to Quest for testing.

Mar 17, 2021

Randox Laboratories: Acusera Control

Randox Laboratories has launched its new range of Acusera Control for D-dimer testing, used to test whether a patient has a blood clotting disorder. The control, for use on a variety of different diagnostic systems, comes in a liquid frozen format and is stable for 28 days when stored between 2 degrees Celsius to 8 degrees Celsius, the Crumlin, Northern Ireland-based firm said.

Mar 09, 2021

Meridian Bioscience Air-Dryable Direct DNA qPCR Blood Mix

Meridian Bioscience has launched its new Air-Dryable Direct DNA qPCR Blood Mix designed for the manufacturing of room temperature-stable molecular diagnostic tests direct from whole blood, plasma, or serum. The mix uses a specialized polymerase and advanced buffer formulation designed specifically for blood samples without the need for DNA purification of the sample. PCR inhibitors in blood samples can result in false negatives or reduced sensitivity in samples where the DNA is not purified.

It is designed to tolerate a high level of inhibitors present in blood, which Meridian said allows for the development of simpler and faster tests. Meridian's mix also replaces the need for lyophilization by using an oven-drying procedure. 

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.

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