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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 over 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. 

Jul 28, 2020

Myriad Genetics: Vectra Report

Myriad Genetics has enhanced its test report for Vectra, a multi-biomarker, molecular blood test for measuring inflammatory disease activity in rheumatoid arthritis patients. The new report provides an estimate of each patient's one-year risk of rapid radiographic progression, factoring in age, gender, and adiposity. Previously, the company reported a measure of patients' current RA inflammation, but the added information in the latest version of the report can inform them of the future risk of joint damage and "further guide [their] medical management decisons," Mark Verratti, president of Myriad Neuroscience and Myriad Autoimmune, said in a statement. 

Jul 23, 2020

SphingoTec IB10 Sphingotest bio-ADM

SphingoTec launched IB10 Sphingotest bio-ADM, a CE IVD-marked point-of-care test to quantitatively determine blood levels of bioactive adrenomedullin. Blood levels of bio-ADM reflect the functional status of the endothelium, the inner cell sheet of blood vessels. The test is available on the company's rapid point-of-care platform Nexus IB10, which uses whole blood samples without pre-processing, requires less than three minutes of hands-on time, and delivers results in about 20 minutes.

Jul 17, 2020

Cepheid Xpert MTB/XDR

Cepheid has launched an assay to detect extensively drug-resistant tuberculosis. The CE-IVD marked Xpert MTB/XDR test uses new 10-color technology and runs on recalibrated GeneXpert instruments. It can be used to rapidly detect resistance to isoniazid, ethionamide, fluoroquinolones, amikacin, kanamycin, and capreomycin directly from patient specimens.

Jul 15, 2020

Congenica Automation

Congenica has updated its clinical decision support platform by launching the Automated Classification of Known Variants product, Congenica Automation. This will provide automated classification as well as evidence and reporting of recurrent 'known' variants that customers observe in their rare disease cases. The new product aims to reduce interpretation and reporting time by 90 percent compared to the company's existing solution, so complex genomic data can be reported in as little as 5 minutes. For example, interpretation and reporting of 4,000 cases with recurrent pathogenic or likely pathogenic variants could be completed in 5 to 8 minutes for each case. Users of the new product can also create their own customized curated variant list to be used for the automated process.

Jul 10, 2020

Bionano Genomics Bionano Prep SP Tissue and Tumor Kit

Bionano Genomics has launched the Bionano Prep SP Tissue and Tumor Kit, a DNA isolation kit for the analysis of tumors and tissues with the company's Saphyr system. The kit is designed to simplify the isolation of ultra-high molecular weight DNA from a variety of solid tumors and tissue types. DNA can be extracted in less than six hours from as little as 5 mg of fresh or frozen tissue. It was validated in bladder, lung, liver, kidney, colon, breast, prostate, brain, thyroid, ovary, testes, and uterus tissue.

Jul 08, 2020

NIST SARS-CoV-2 Research-Grade Test Material

The National Institute of Standards and Technology has developed a reference material to aid in the evaluation and development of RT-qPCR assays for SARS-CoV-2. The reference material consists of two synthetic RNA fragments from the SARS-CoV-2 genome in a background of 5 ng/μL human Jurkat RNA (stored at –80° C, BSL-1). Fragment 1, which has a total length of 3,985 nucleotides, and includes SARS-CoV-2 sequence 25949-29698 of isolate USA-WA1/2020; and Fragment 2, which has a total length of 3,790 nucleotides and includes SARS-CoV-2 sequence 12409-15962 of isolate USA-WA1/2020.

NIST said the synthetic fragments can be used to assess limits of detection for SARS-CoV-2 assays or calibrate other in-house or commercial SARS-CoV-2 controls. NIST characterized the material by size and using multiple reverse transcription droplet-digital PCR and qPCR methods. The agency is making the material free of charge through funding from the Coronavirus Aid, Relief, and Economic Security Act, in exchange for user feedback to help improve and further develop the material. 

Jul 08, 2020

Illumina TruSight Software Suite

Illumina has launched the TruSight Software Suite for genetic disease testing using whole-genome sequencing. It enables sample-to-report analysis, allowing users to go from 5 million variants to a small number of candidates in a rapid and scalable way. The software suite, developed in collaboration with the Mayo Clinic and other experts and offered as a "software as a service" solution, promises to reduce test interpretation time from as much as several weeks to as little as a few hours. It is certified for HIPAA compliance, ISO 27001, and ISO 13485 and is built to enable data privacy and compliance with the principles of the European Union's General Data Protection Regulation.

Jul 01, 2020

Thermo Fisher Scientific MAS Omni Infectious Disease Quality Controls

Thermo Fisher Scientific has launched its MAS Omni Infectious Disease quality control sets for monitoring the performance of serological assays. These new control sets are for analytes such as HIV 1&2, hepatitis B & C virus, syphilis, and human T- cell leukemia virus I/II. These infectious positive and negative quality controls are third-party, independent external controls that can potentially reduce costs without sacrificing quality or throughput of the control set, the firm said. The Thermo Scientific MAS Omni Infectious Controls are available in the US and Japan as IVD products and are intended for clinical use.

Jul 01, 2020

Myriad Genetics Home Sample Collection Kit for GeneSight Psychotropic

Myriad Genetics has launched an at-home sample collection kit for its pharmacogenetic test GeneSight Psychotropic. The DNA sample for this test is typically collected in a physician's office, but the new kit will allow patients to use a swab to collect a sample from inside their cheeks and mail it to the Myriad Neuroscience CLIA-certified and CAP-accredited lab for analysis. Even though the new kit allows home sample collection, the test must be ordered by a licensed healthcare provider.

Mark Verratti, president of Myriad Neuroscience, said in a statement that during the COVID-19 pandemic there has been a rise in patients experiencing depression and anxiety, while at the same time more physicians are practicing telemedicine to limit patients' exposures to the virus. Verratti added that the new collection kit allows clinicians to continue to use the GeneSight test as part of developing a treatment plan for their patients suffering from depression or anxiety.

Jun 29, 2020

GenMark Diagnostics ePlex Respiratory Pathogen Panel 2

GenMark Diagnostics said its ePlex Respiratory Pathogen 2 (RP2) Panel is now available for US commercial distribution and clinical use. The panel is designed to provide results in less than two hours for SARS-CoV-2 and other common respiratory pathogens, including influenza, adenovirus, rhinovirus, and respiratory syncytial virus (RSV). 

GenMark said that earlier this month, it had applied to the US Food and Drug Administration for Emergency Use Authorization of its ePlex Respiratory Pathogen 2 Panel. In March, the company received EUA for its ePlex SARS-CoV-2 Test.

Jun 29, 2020

NeoGenomics Liquid Biopsy Assays

NeoGenomics announced the launch of three new liquid biopsy products for advanced non-small cell lung cancer, all solid tumor types, and breast cancer.

The InVisionFirst-Lung liquid biopsy assay tests 37 genes related to the care of advanced NSCLC and covers all National Comprehensive Cancer Network guideline-recommended genomic drivers with targeted therapies for NSCLC. NeoGenomics partnered with Inivata to commercialize the test. 

The NeoLab Solid Tumor Liquid Biopsy is a next-generation sequencing test for genomic profiling of solid tumors. The test is part of the NeoLab suite of assays providing biomarker evaluation for patients with hematologic diseases who can't have a bone marrow biopsy and whose peripheral blood counts are low. 

The Qiagen Therascreen PIK3CA RGQ PCR kit is a companion diagnostic approved by the US Food and Drug Administration for use with alpelisib (Novartis' Piqray) that detects 11 clinically actionable mutations in the PIK3CA gene. NeoGenomics will launch the test in situations where PIK3CA testing can't be performed using tumor tissue due to insufficient samples, low quantities of tumor cells, or tissue sample decalcification. 

Jun 25, 2020

Guardant Health GuardantInform

Guardant Health has launched a clinical-genomic database service it calls GuardantInform, intended to help accelerate research and development of the next generation of cancer therapeutics. The platform offers biopharma partners de-identified longitudinal clinical information and genomic data collected from the Guardant360 liquid biopsy test, which the firm has performed on more than 100,000 samples to date.

Among potential applications, Guardant highlighted targeted drug development, clinical trial optimization, and post-marketing pharma studies. According to the company, recent data presented at the AACR virtual annual meeting further support the database's potential in these areas.

Jun 23, 2020

LGC Maine Standards Validate ACTH Linearity and Calibration Verification Test Kits

LGC Maine Standards has released the Validate ACTH Linearity and Calibration Verification Test Kits to document linearity, for calibration verification, and for analytical measurement range verification of Adrenocorticotropic Hormone. The product provides five concentrations across the Elecsys-ATCH method on Roche's Cobas instrument and is formulated in a human plasma matrix. 

The product helps minimize manual dilutions and fulfills various quality control requirements, strengthening LGC's product range for endocrine testing, which includes 17 analytes. 

Jun 19, 2020

LGC SeraCare AccuSet SARS-CoV-2 Performance Panel

LGC SeraCare has released the AccuSet SARS-CoV-2 Performance Panel, an eleven-member validation panel of undiluted, naturally occurring human plasma samples. Ten panel samples represent collections from multiple individuals positive for antibodies to SARS-CoV-2; a single negative sample is also included, according to the company's website. The panel is designed to support validation studies for SARS-CoV-2 diagnostic developers and to help meet assay verification requirements in clinical laboratories.

Jun 18, 2020

Novacyt Exsig Direct, Exsig Mag Extraction Kits; COVID-HT Test

Novacyt has launched two new extraction kits  Exsig Direct and Exsig Mag  for COVID-19 testing. The kits can be used with all open PCR instrument platforms. Exsig Direct is a direct-to-PCR extraction kit designed to be used with Novacyt's COVID-19 test. It employs a combination of optimized buffers to extract COVID-19 RNA from clinical samples. Exsig Mag runs on multiple automated magnetic bead extraction systems commonly used by clinical laboratories and has been developed to enhance extraction of COVID-19 RNA from clinical samples. Exsig Mag can be used with Novacyt's COVID-19 test or in combination with other COVID-19 PCR tests.

The firm has also launched a CE marked high-throughput SARS-CoV-2 PCR tests called COVID-HT.

Jun 17, 2020

Sysmex America XF-1600 Flow Cytometer

Sysmex America launched the XF-1600 flow cytometer. A company official said the instrument works in tandem with Sysmex's PS-10 Sample Preparation System to automate antibody staining, incubation, and flow cytometry analysis. It has 10 detectors for fluorescence and three light sources. 

Jun 17, 2020

Hemex Health Gazelle Hb Variant Test

Hemex Health has launched the Gazelle Hb Variant test for its Gazelle platform. The test automatically identifies and quantifies sickle cell disease and other Hb variants from a blood sample in about eight minutes. It has received the CE mark and regulatory approval in India and Ghana. The Gazelle platform integrates AI with automated, miniaturized electrophoresis, as well as internal and cloud-based data storage. A malaria test is also planned for use on the platform and is being reviewed by regulators in India, the company said.

Jun 08, 2020

Omega Bio-tek Mag-Bind Viral RNA Xpress Kit for COVID-19 Testing

Omega Bio-tek launched the Mag-Bind Viral RNA Xpress Kit for COVID-19 testing. The new magnetic bead-based extraction kit is designed to isolate viral RNA from nasopharyngeal swabs that are dry or in viral transport media. The kits are adaptable to most liquid testing platforms, including the Hamilton Microlab STAR, Microlab MagEx STARlet, and NIMBUS; the Thermo Fisher Scientific KingFisher and Applied Biosystems MagMax 96; Qiagen BioSprint; and Tecan DreamPrep NAP. Omega Bio-tek said the kit enables researchers to reduce their number of reagents and protocol steps while allowing efficient recovery of viral nucleic acids with minimal inhibitor carryover.

Jun 08, 2020

NeuMoDx Molecular Extraction-Only Software for NeuMoDx 288 and 96 Systems

NeuMoDx Molecular has launched new software for the NeuMoDx 288 and 96 Molecular Systems to assist in faster nucleic acid extractions. This new software is 'extraction only,' allowing users to extract DNA and RNA from approximately 200 and 400 samples within an eight-hour period, respectively. Operators of NeuMoDx's systems are able to continuously load patient samples with random access and receive results within approximately one hour.

May 28, 2020

Analytik Jena Biometra TRobot II and qTOWER³ Auto Thermal Cyclers

Jena, Germany-based life science firm Analytik Jena has introduced two new thermal cyclers. The Biometra TRobot II is a small footprint PCR module that can be used to save space in a robotic setup, while the qTOWER³ Auto is a qPCR thermal cycler useful for fully automated qPCR applications.

May 21, 2020

Indica Labs, Octo: COVID Digital Pathology Repository

Indica Labs and Octo launched the COVID Digital Pathology Repository, an online collection of high-resolution microscopic COVID-related human tissues hosted at the US National Institutes of Health. The repository enables international collaboration by providing a centralized, cloud-based repository for sharing and annotating digital whle-slide images of lung, liver, kidney, and heart tissues from patients who were infected with the SARS-CoV-2 coronavirus, as well as SARS and MERS. The images, annotations, and metadata will be used as a reference dataset for education, research, and future clinical trials. The repository is underpinned by Indica's Halo Link software, an image management platform. For the repository, Halo Link will be deployed in a web portal developed by Octo and Axle Informatics.

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