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Oct 14, 2020

Paragon Genomics CleanPlex ARS-CoV-2-Related NGS Assays

Paragon Genomics has launched four new coronavirus-related CleanPlex next generation sequencing (NGS) assays. The new panels widen the capabilities of the firm's CleanPlex SARS-CoV-2 Research and Surveillance Panel, which allows researchers to sequence the SARS-CoV-2 genome and obtain accurate nucleic acid-level information on the virus for strain typing, mutation monitoring, and other epidemiological studies.

Paragon's CleanPlex ACE2 & TMPRSS2 Panel identifies genetic mutations in patients that are related to disease susceptibility and severity. The test targets genes affecting the binding affinity and expression of angiotensin-converting enzyme 2 (ACE2) and transmembrane serine rotease 2 (TMPRSS2). The panel interrogates the entire coding region of ACE2 and TMPRSS2, along with more than 70 curated unique quantitative trait loci that regulate their expression. Paragon noted the panel uses CleanPlex technology's three-hour workflow to produce enriched NGS libraries for all major sequencing platforms.

Paragon's CleanPlex SARS-CoV-2 FLEX Research Panel anticipates increases in SARS-CoV-2 viral mutations and offers extra assurance that mutation detection and genome coverage remain optimal. The FLEX panel specifically focuses on variant analysis and tracking of mutations over time. The test also includes degenerate primers and human RNA primer controls for more confident negative sample calling, especially when viral copies are not present or are at extremely low counts, the firm said.

The company also launched its plated 384 Unique Dual-Indexed PCR Primers for Illumina sequencing of its CleanPlex SARS-CoV-2 NGS panels. The primers will allow additional multiplexing capability so that researchers can simultaneously run up to 3,072 CleanPlex sequencing samples on Illumina NovaSeq instruments.

In anticipation of the upcoming flu season, Paragon is also releasing an early-access edition of the CleanPlex Respiratory Research Panel, which combines assays for SARS-CoV-2, influenza A subtypes H1N1, H1N2, H3N2, and influenza B. The combination panel allows for simultaneous influenza detection with SARS-CoV-2 detection or whole-genome sequencing. The extra sensitivity and additional coverage of the multiplex PCR-based method also works for high-throughput sample pooling and screening strategies, the firm said. Paragon expects to expand the panel to include respiratory syncytial virus and possibly other respiratory viruses in the future.

Oct 12, 2020

Exact Sciences Oncotype MAP Pan-Cancer Tissue Test

Exact Sciences has introduced the Oncotype MAP Pan-Cancer Tissue rapid, comprehensive tumor profiling panel test for patients with advanced, metastatic, refractory, or recurrent cancer. Oncotype MAP provides clinically actionable information from genomic alterations in hundreds of cancer-related genes, including tumor mutations, copy number variants, fusions, tumor mutation burden, microsatellite instability, and protein expression, allowing physicians to understand a patient's tumor profile and effectively recommend targeted therapies or clinical trials, the company said.

The test, which Exact acquired as part of its merger deal with Paradigm Diagnostics in February, was previously called PCDx. 

Oncotype MAP has a turnaround time of three to five business days to guide timely treatment decisions, a sample requirement of as little as 3 mm of tissue or 2-3 slides, and accurate and comprehensive results based on next generation sequencing and immunohistochemistry. Exact also noted that patients who used a previous generation of the test had a 43 percent rate of progression-free survival compared to 5 percent for patients who did not utilize the test.

The Oncotype MAP test report is based on NCCN Compendium-based recommendations, along with potential evidence-based therapies and clinical trials. The report is currently tailored to support clinical decision-making by showing actionable biomarkers associated with more than 100 evidence-based therapies, more than 45 combination therapies, and more than 650 active clinical trial associations, Exact added.

Oct 09, 2020

Bio-Rad Laboratories Opus Real-Time PCR Systems and BR.io Software

Bio-Rad Laboratories has launched two new qPCR instruments, the CFX Opus 96 and CFX Opus 384 Real-Time PCR Systems. The systems offer enhanced usability, with features designed for academic, commercial, and biopharma labs. The firm also announced early access to BR.io, a cloud-based software that enables users to design experiments, analyze data, and access their experiments remotely.

Oct 09, 2020

LabCorp: Care Intelligence Oncology Module

Laboratory Corporation of America launched its Care Intelligence Oncology Module to help oncologists access and compare data points and performance metrics. The module integrates with electronic health records and other clinician practice management tools and systems. It combines clinical, claims, pharmacogenomics, and staging data, as well as genetic and other clinical lab test results, and a patient's Eastern Cooperative Oncology Group Performance status. The tool can also identify patients who may qualify to participate in clinical studies for new treatments through Covance, LabCorp's drug development business, and monitor the patients' progress in studies.

Oct 07, 2020

Meridian Bioscience Inhibitor-Resistant qPCR Chemistries

Meridian Bioscience launched two novel inhibitor-resistant qPCR chemistries for the detection of DNA and RNA molecules directly from liquid biopsy samples without needing nucleic acid extraction. The mixes can be used to develop cancer diagnostic tests and workflows requiring fast turnaround times while ensuring high specificity. 

The mixes can tolerate high levels of inhibitors in blood, allowing for improvements in limit of detection by adding more sample in the reaction, Meridian said. Studies have shown superior sensitivity compared to other mixes, even in samples with difficult conditions, such as 20 percent blood, the company added. 

Establishing molecular tests to detect circulating cancer biomarkers can be difficult due to sample variability and inhibitory properties of the specimen, issues Meridian says its two new mixes can help fix. 

Oct 06, 2020

Biocartis: SeptiCyte Rapid

Biocartis has launched its CE-marked SeptiCyte Rapid assay for its Idylla platform. The test distinguishes sepsis from non-infectious systemic inflammation in patients suspected with sepsis and provides results within an hour, the firm said. 

Oct 02, 2020

New England Biolabs Luna Probe One-Step RT-qPCR 4X Mix with UDG

New England Biolabs has launched the Luna Probe One-Step RT-qPCR 4X Mix with UDG. The master mix is optimized for the sensitive detection of target RNA sequences for probe-based applications, and allows for increased throughput by multiplexing up to five targets. 

The product features also include 4X concentration for increased amounts of sample input, addition of UDG and dUTP to reduce the risk of carryover contamination, Luna WarmStart RT paired with Hot Start Taq for reactions at room temperature, and a visible, non-interfering blue tracking dye for ease of use.

Sep 24, 2020

LabCorp Resolution ctDx Lung Assay

LabCorp has launched the Resolution ctDx Lung assay for patients with non-small cell lung cancer (NSCLC). The test will be run by Resolution Biosciences and detects actionable mutations associated with the disease in a standard blood sample. The firm said the test can provide valuable information to help select the most effective targeted treatments for individual patients. In addition, LabCorp noted that the test is covered by Medicare. 

Sep 23, 2020

Exagen Avise Vasculitis AAV

Exagen launched the Avise Vasculitis AAV test panel of individual analytes to assess and monitor anti-neutrophil cytoplasmic antibody-associated vasculitis. ANCA-associated vasculitis is characterized by vascular inflammation and damage, and early symptoms of the disease vary widely. Exagen's test is intended for use in patients suspected of small vessel diseases, such as granulomatosis with polyangiitis, microscopic polyangiitis, and eosinophilic granulomatosis with polyangiitis. 

Sep 22, 2020

Bio-Techne RNA-Protein Co-Detection Assays

Bio-Techne has expanded its Advanced Cell Diagnostics-branded RNAscope technology with the release of RNA-Protein Co-Detection Assays. RNAscope technology is an advanced in situ hybridization assay that enables visualization of single-molecule gene expression with single-cell resolution directly in intact cells and tissues. The codetection assays allow researchers to simultaneously examine gene expression specific to cell types and identify cellular sources of secreted proteins. The new workflow enables a wider range of IHC-validated antibodies to be combined with RNA ISH.

Sep 18, 2020

Bio-Rad Laboratories StarBright Violet 515 Dye for Flow Cytometry

Bio-Rad Laboratories has launched the StarBright Violet 515 (SBV515) dye, the first of a new range of fluorescent nanoparticles for flow cytometry. SBV515 has an excitation maximum at 401 nanometers and emission maximum of 516 nanometers, offering improved brightness to better resolve rare and low antigen density populations. It has a narrow emission profile to reduce spillover into neighboring filters and minimize excitation by other lasers, making it suitable for inclusion in multicolor panels. The dye is not susceptible to photobleaching, delivers high lot-to-lot reproducibility, and is stable at 4° C with no loss of signal, Bio-Rad said.

Sep 18, 2020

RenalytixAI: KidneyIntelX

RenalytixAI has announced the commercial launch of its KidneyIntelX clinical testing platform, which provides risk assessment of progressive decline in kidney function or kidney failure in patients with early-stage diabetic kidney disease. KidneyIntelX applies machine-learning algorithms to assess predictive blood-based biomarkers and electronic health record data to identify progressive kidney disease in at-risk patients. 

The firm submitted a 510(k) application to the US Food and Drug Administration for the assay last month. 

Sep 16, 2020

Everlywell Current STD Testing Service

Everlywell has launched Current, a membership program for sexually transmitted disease testing. For $14.99 per month, members can get tested for one STD of their choice each month. Tests are sent to members with instructions and materials to collect their samples, which are then sent to a CLIA-certified lab. The physician-reviewed results are sent to subscribers in a few days, and if a test result is positive, an Everlywell physician from a third-party telehealth network will contact the patient to discuss next steps and prescribe treatment, if necessary.

Sep 15, 2020

Progentec aiSLE DX Flare Risk Index

Progentec announced the launch of a novel blood test to determine the likelihood of a patient with systemic lupus erythematosus experiencing a flareup in the next 12 weeks. The aiSLE DX Flare Risk Index uses blood-based biomarkers that are altered before flare symptoms occur and uses the Ella platform. 

A blood test measures 11 soluble mediators, including cytokines and chemokines, and a machine learning algorithm creates the score from the analytes. Originally, 52 immune mediators were examined in study participants for baseline and follow-up plasma levels, but continued studies during test development decreased the number of informative mediators to 11.

According to the company, lupus patients with a positive index score are five times more likely to experience a flare than a patient with a negative score.

Sep 14, 2020

Bianano Genomics Lineagen EpiPanel Dx Plus

Bionano Genomics' recent acquisition Lineagen has launched the EpiPanel Dx Plus, a laboratory-developed test for epilepsy-related conditions.

The proprietary gene panel is based on 223 genes selected from a literature review, including genes with pathogenic variants identified in more than 2,000 epileptic patients tested by Lineagen. The test is designed for patients who have experienced seizures, infantile spasms, encephalopathy, or febrile seizures and can predict the recurrence risk for other members of the family and allows for personalized treatment. It has an expected diagnostic yield of 30 percent.

Sep 03, 2020

Yourgene Iona Nx Noninvasive Prenatal Test

Yourgene this week launched the Iona Nx Noninvasive Prenatal Test (NIPT) after having applied CE marking in June. Iona Nx is designed to run on Illumina's NextSeq 550 Dx next-generation sequencing platform, and uses the Yourgene SP150 and Yourgene QS250 instruments to combine DNA extraction, sample preparation, and enrichment ahead of the sequencing step. The QS250 is powered by Ranger technology from Coastal Genomics, which Yourgene acquired recently acquired, and features a step that enriches fetal fraction two-fold, reducing the amount of sequencing necessary and decreasing cost. The assay has greater than 99.99 percent accuracy, according to the company, and features whole-genome analysis including for trisomy 21, 18, and 13; sex chromosomal aneuploidies; other autosomal aneuploidies; and optional fetal sex determination. It will also feature microdeletion analysis in the future, the company said.

Yourgene will initially transition existing customers to the new assay in the UK and France, followed by other European territories. 

Sep 02, 2020

Castle Biosciences DecisionDx-SCC

Castle Biosciences has launched DecisionDx-SCC, its prognostic gene expression profile test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC). DecisionDx-SCC is a qRT-PCR assay of 40 genes that uses a neural network algorithm to classify individual risk of squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1, 2A, or 2B risk category, predicts individual metastatic risk to inform risk-appropriate management.

Sep 02, 2020

Agilent SureSelect XT HS2 RNA Reagent Kit

Agilent has launched its SureSelect XT HS2 RNA Reagent Kit. The kit offers a modular design that provides a simple and parallel approach for both RNA and DNA samples, which the firm noted will help customers streamline and combine workflows without losing time optimizing different kits for different sample types.

Agilent's kit will allow customers to accurately profile gene expression and detect RNA fusions using low-input formalin-fixed paraffin-embedded samples. The kit supports 384 unique dual sample indexes and helps customers to multiplex hundreds of samples in a single sequencing run without worrying about index hopping, the firm said. The kit also features molecular barcodes for more efficient de-duplication of sequencing reads and more accurate gene expression analysis.

Sep 02, 2020

BioReference Laboratories OnKoSight Advanced

Opko Health's BioReference Laboratories announced the launch of its next-generation sequencing assay OnKoSight Advanced, which enables DNA mutational profiling of tumor samples. The test, developed by BioReference's specialty oncology division GenPath, offers targeted gene content aligned with recent National Comprehensive Cancer Network and World Health Organization guidelines. The panels include key biomarkers, such as tumor mutation burden and tumor-only microsatellite, and are tumor-type specific. They are also "optimized to exclude extraneous gene content," the company said.  

Aug 18, 2020

Motic Digital Pathology MoticFlow Telepathology Platform

Motic Digital Pathology launched its MoticFlow telepathology platform, a cloud-based system for consultation, case-sharing, and peer review using digital slides. The platform connects pathologists to patients and laboratories and provides a turnkey solution for multi-site management, international projects, and other collaborative pathology projects, especially amidst the challenges of COVID-19, the firm said.

MoticFlow enables the adjusting of slide images, making annotations, and summarizing findings along with a tracked case history. The solution also includes secure cloud storage options and can interface with hospital and laboratory information systems to automate case information entry.

Aug 11, 2020

Centogene CentoMD 5.8

Centogene has released an update to its curated rare disease mutation database, CentoMD 5.8. This latest version includes more than 12.7 million unique variants, greater than 81,000 classified and curated variants, and over 199,000 individuals linked to HPO terms. Since December 2019, the number of cases in CentoMD has grown to more than 430,000, covering more than 120 countries.

Aug 07, 2020

NIST SARS-CoV-2 Synthetic Gene Fragments

Researchers at the National Institute of Standards and Technology have produced synthetic gene fragments from SARS-CoV-2. Shipped in vials with a data sheet listing the concentration of fragments in the solution, the RNA fragments can be used to measure the sensitivity of tests for the coronavirus. They can also use the synthetic RNA to develop more sensitive tests or new kinds of tests, NIST said. Each solution contains about 1 million copies per microliter. NIST is releasing the synthetic RNA as a research grade test material while it expects to further develop it as a standard reference material. The material is free to researchers, test manufacturers, and testing labs. Technical information and instructions for requesting the material are available here.

Aug 06, 2020

GeneDx GenomeXpress

GeneDx, a subsidiary of BioReference Laboratories/Opko Health, has launched GenomeXpress, a rapid genome sequencing test. GenomeXpress includes both protein-coding and non-coding regions of the genome including promoter, intronic, and untranslated regions, enabling the detection of characterized/pathogenic variants in regions that are not assessed by exome sequencing. The company delivers a written report for all confirmed variants in known disease-causing genes to the ordering healthcare provider within approximately seven days after testing. It also provides a written report for all confirmed variants within approximately 14 days after the start of testing. 

Aug 04, 2020

Adaptive Biotechnologies ImmunoSeq T-Map COVID Service

Adaptive Biotechnologies has launched the immunoSeq T-Map COVID, a proprietary research product and data-analysis service to measure the T cell immune response to vaccines in development and track the persistence of that response over time.

The product leverages data from more than 1,000 patients to provide researchers with a quantitative map of T cell receptors and SARS-CoV-2 antigens that elicit an immune response. These data will be available through Adaptive's cloud-based immunoSeq Analyzer and is powered by ImmuneCode, an open database developed in partnership with Microsoft.

Aug 03, 2020

Cytek Biosciences cFluor Reagents

Flow cytometry firm Cytek Biosciences announced the launch cFluor reagents, short for "Cytek Fluorochrome," that are validated on the firm's Aurora and Northern Lights full spectrum cell analysis systems. The first batch of reagents includes cFluor YG584, cFluor B548, and cFluor R710 and allows users to reveal more from the full spectrum panel with a new option excitable by the yellow-green, blue, and red lasers respectively. Other dyes are coming soon, the firm said. 

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