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SQI Diagnostics RA Test, Celiac Disease Monitoring Service

Jan 28, 2019

SQI Diagnostics announced its partner Microdrop has launched two at-home testing products for rheumatoid arthritis and celiac disease. The RA test measures biomarkers for the condition and provides information to patients for discussions with their docturs. Microdrop also launched a celiac disease monitoring service, which allows a patient to be continuously monitored to determine the effectiveness of their diet and treatment. The celiac monitoring service follows on the Imaware celiac screening test launched last month by Microdrop.

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Oct 27, 2020

Enzo Biochem GoTestMeNow

Enzo Biochem has launched GoTestMeNow, an online platform that enables consumers to directly order physician-authorized laboratory tests. GoTestMeNow can be used to access necessary medical tests without the need for a doctor's office visit, the company said. Specimen collection and testing is accomplished through a network of patient service centers in the New York/New Jersey metro area and consumers can get their results through a secure online portal. The platform will also facilitate any issues related to payment, including insurance coverage.

The GoTestMeNow platform will initially support access to COVID-19 molecular and antibody testing, and will then be expanded to offer access to a broad range of additional tests in the near future, Enzo added.

Oct 23, 2020

Fabric Genomics Fabric GEM Algorithm for Genetic Disease Diagnosis

Fabric Genomics has launched Fabric GEM, an algorithm designed to identify the likely genetic cause of rare diseases from next-generation sequencing data. Fabric GEM, the latest product in the Fabric Enterprise software suite, uses artificial intelligence to analyze sequencing data (including complex structural variants) and patient clinical information in order to perform probabilistic disease matching and speed genetic diagnoses. The algorithm was developed in collaboration with Mark Yandell of the University of Utah and Stephen Kingsmore of Rady Children's Institute for Genomic Medicine, Fabric said.

Oct 22, 2020

Bionano Genomics Access v1.6, Solve v3.6

Bionano Genomics has updated its suite of data analysis and visualization software tools for its Saphyr genome mapping platform. The new version of Bionano Access is designed to simplify and accelerate every step in the data-analysis workflow, enabling clinical labs to develop tests on the Saphyr more easily. It builds on the Bionano EnFocus FSHD Analysis tools for the automated analysis of variants in a form of muscular dystrophy to allow for similar automated variant analysis for EnFocus panels for other genetic conditions. These include autism spectrum disorder, developmental delay, and repeat expansion disorders, as well as hematologic malignancies and solid tumors. The new version also enables Bionano EnFocus FSHD data to be analyzed on a PC rather than in the cloud or on a compute cluster. In addition, it reduces the time and increases capacity for analyses run on Bionano's cloud-based platform.

Oct 20, 2020

Genome Diagnostics NGSgo-MX11-3 Multiplexing for HLA Typing

Genome Diagnostics has launched NGSgo-MX11-3, its latest addition to a series of singleplex and multiplex amplification strategies for HLA typing by NGS. NGSgo-MX11-3 consists of amplification primers for eleven HLA genes — HLA-A, -B, -C, -DRB1, -DQB1 and -DPB1, DRB3/4/5, DQA1, and DPA-1 — in three mixes per sample. The three-tube design results in low noise levels and well-balanced alleles, making the data quality of the 11-loci multiplex similar to a singleplex strategy, Genome Diagnostics said. NGSgo-MX11-3 is available on a research-use-only basis. The firm anticipates that it will become available as a CE-marked IVD.

Oct 15, 2020

Magnolia Medical Steripath Micro Initial Specimen Diversion Device

Magnolia Medical Technologies launched its new Steripath Micro Initial Specimen Diversion Device, an FDA-cleared product indicated to reduce blood culture contamination. The device uses syringe-driven negative pressure to divert and sequester the first .6 to .9 mL of blood. The user then presses a button to isolate the diverted blood and a second blood flow pathway is opened to collect the blood specimen for culture in the syringe.

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.