Close Menu

EntroGen Multiplexed Leukemia Translocation Panel

Nov 18, 2016

EntroGen has launched the Leukemia Translocation panel. It is a multiplexed, one-step real-time PCR assay that detects eleven variants in 6 common leukemia associated translocations simultaneously. The panel detects and identifies AML1-ETO, CBFB-MYH11, MLL-AF4, TEL-AML1, E2A-PBX1, and PML-RARA fusion gene transcripts from total RNA isolated from blood or bone marrow. The product is compatible with several leading multi-channel real-time PCR instruments capable of detecting four commonly used fluorescent probes and produces results in just 90 minutes, the company said. It can also be run together with the company's p190 and p120 real-time PCR kits for a comprehensive test for fusion genes implicated in CML, ALL, APL, and AML, the company said.

More Like This

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 co-detection 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.