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ASI HiPath

May 11, 2017

Applied Spectral Imaging introduced the HiPath system for the imaging and analysis of PD-L1 assays. it determines PD-L1 protein expression by calculating a percentage of viable tumor cells show partial or complete membrane staining while providing automatically the rumor proportion score. HiPath provides digital automation of IHC tissue analysis, and allows pathologists to capture images, receive computer-aided scoring, and generate automatic reports with comple case statistics, ASI said. 

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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. 

Jul 31, 2020

Myriad Genetics Amplify for Fetal Cell-Free DNA Sequencing

Myriad Genetics has launched Amplify, which sequences the fetal cell-free DNA fragments circulating in a mother's blood and increases the fetal fraction in a sample for non-invasive prenatal screening. The company is hoping that the technology will improve the performance of its Prequel NIPS test. The analytical validation of Amplify involved samples from more than 1,000 women and showed that the fetal fraction was 2.3 times greater on average compared to standard NIPS. The improvement reduces false positive and false negative results, including for common aneuploidies, expanded aneuploidies, microdeletions, and a baby's sex, Myriad noted. The company also said that the technology will reduce the number of sampels that fail to produce a result due to low fetal fraction and deliver results to 99.9 percent of patients. 

Jul 29, 2020

HTG Molecular Diagnostics HTG EdgeSeq Pan B-Cell Lymphoma Panel

HTG Molecular Diagnostics has launched its HTG EdgeSeq Pan B-Cell Lymphoma Panel, which the firm said is designed to provide molecular characteriation of aggressive, indolent, and rare lymphomas. The research-use-only panel enables investigators to measure the expression of about 300 genes linked to the lymphoma transcriptome. The panel is available in kit form or as a service at HTG's VERI/O laboratory.