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PGDx CancerSELECT 125 Test

Dec 21, 2016

Personal Genome Diagnostics has launched the CancerSELECT 125 test for pan-cancer tumor profiling. The test identifies clinically actionable and functionally important sequence mutations, and structural alterations across multiple cancer types using the company's proprietary technologies and bioinformatics. The test also reports microsatellite instability status to assess potential response to checkpoint inhibitor therapies. Additionally, it includes matched sequencing of normal patient tissue to accurately filter out germline variants.

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Jul 14, 2020

10x Genomics Chromium Single Cell Immune Profiling v2

10x Genomics has launched the Chromium Single Cell Immune Profiling v2 product. It extends the capabilities of the original version, offering up to 60 percent increased gene detection sensitivity. The product can be used to characterize adaptive and innate immune cell diversity; identify and characterize rare cell types and biomarkers; analyze tissue microenvironment, disease progression, and drug immune response; perform large-scale antibody and TCR discovery for novel antigens; characterize immune responses to infection by measuring clonal expansions and immune cell phenotypes; and study genes and pathways with predesigned gene expression panels.

Jul 13, 2020

New England Biolabs RUO SARS-CoV-2 Rapid Colorimetric LAMP Assay Kit

New England Biolabs has launched a real-time loop-mediated isothermal amplifcation-based (RT-LAMP) assay kit to detect SARS-CoV-2. The research-use-only kit, called the SARS-CoV-2 Rapid Colorimetric LAMP Assay Kit, enables visual amplification detection using a simple heat source, with results in 30 minutes. The kit includes the firm's WarmStart Colorimetric LAMP 2X Master Mix with uracil-DNA glycosylase, a primer mix targeting the N and E regions of the SARS-CoV-2 genome, an internal control primer set and positive control template, as well as guanidine hydrochloride to increase the speed and sensitivity of the RT-LAMP reaction.

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

Sema4 Signal

Sema4 has introduced Sema4 Signal, a line of bioinformatics tools and exome-based somatic and hereditary cancer genomic tests to support precision oncology care. The initial release, Sema4 Signal Hereditary Cancer, features a 112-gene panel and 16 subpanels, supported by customizable video education, analytics services, workflow tools, and genetic counseling. 

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 07, 2020

Horizon Discovery Cas9, dCas9-VPR Cell Lines

Horizon Discovery has released its stably expressing Cas9 and dCas9-VPR cell lines to aid researchers in gene knockout and gene activation experiments, respectively. The cell lines are optimized to work alongside Horizon's Edit-R predesigned synthetic single-guide RNA and CRISPRa guide RNA, for complete, simple, and streamlined CRISPR gene editing and modulation workflows.

The Cas9 and dCas9-VPR stable cell lines were generated using Horizon's Edit-R Lentiviral particles with a blasticidin resistance cassette, and are provided in pooled format. The cell lines are QC verified and validated to ensure stable expression and functionality of Cas9 or dCas9-VPR endonuclease in a range of common cell backgrounds, the company said. Both cell lines are available in the same background to enable loss- and gain-of-function studies to be performed in parallel. 

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 30, 2020

Twist Bioscience Respiratory Virus Research Panel

Twist Bioscience has launched the Twist Respiratory Virus Research Panel, a next-generation sequencing approach to detecting 29 common human respiratory viruses including SARS-CoV-2, several other coronaviruses, influenzas, rhinoviruses, and respiratory syncytial virus. The research-use-only panel will be bundled with an analysis platform from One Codex to enable a complete workflow beginning with Twist's target enrichment panel and ending with publication-ready visuals, the company said. The panel includes RNA- and DNA-based viruses in one kit with 41,047 nucleic acid probes, can detect as little as 100 copies of viral material, and has coverage of greater than 99.9 percent of the genome at 1X or greater post-enrichment.

Jun 30, 2020

Flagship Biosciences TissueInsight

Flagship Biosciences has launched a new clinical diagnostics immuno-oncology service called TissueInsight, which provides CLIA-reportable PD-L1 results along with data about a tumor's microenvironment to pathologists, oncologists, and immunologists to aid them in optimizing care for cancer patients. According to the company, users of the service follow their normal IHC slide staining process, then scan the slides and send the images to Flagship, which analyzes them with their proprietary image-analysis process. TissueInsight gives rapid, data-rich tissue interpretation and removes the inherent variability of subjective manual tissue scoring, the company said. Along with its CLIA-reportable results, TissueInsight tumor microenvironment data includes information on tumor infiltrating lymphocytes and macrophages, the company added.

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 26, 2020

Oxford Nanopore Technologies Q Line

Oxford Nanopore Technologies has launched a number of nanopore sequencing products, called Q Line, for diagnostics and other regulated markets. The Q Line products are ISO9001-qualified and allow for sequencing in a locked-down, standardized format. They are designed for water testing, veterinary diagnostics, pharmaceutical research, industrial diagnostics, forensics, and clinical research applications. The first Q Line product is the GridIon Q, a locked-down version of the GridIon sequencer with an integrated compute system. It will be available with two kits, Ligation Sequencing Kit Q and Native Barcoding Expansion Q. More Q Line products will follow, including a MinIon MK1C Q, a Flongle Q, and additional kits.

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. 

The editorial board of the Pittsburgh Post-Gazette says other lawmakers should take Florida's approach and provide additional protections against genetic discrimination.

The Hill reports 17 states and the District of Columbia are suing over a new policy that would strip international students of their visas if they only attend classes online.

Centers for Disease Control and Prevention employees call on the agency to label racism a public health crisis and examine its own policies, NPR reports.

In PNAS this week: genetic evidence for Inca resettlement, analysis of spermatogonial stem cell transcriptomes, and more.

Jul
15
Sponsored by
LGC SeraCare Life Sciences

Cancer immunotherapy is an exciting new advance for the successful treatment of many forms of metastatic cancer.

Jul
22
Sponsored by
Thermo Fisher Scientific

Luis A. Alcaraz, cofounder of Bioarray and Journey Genomics, accredited diagnostic and research labs based in Alicante, Spain, will review how his teams use advanced genomic techniques for carrier screening research as well as for preimplantation genetic testing (PGT) in embryos for both aneuploidies (PGT-A) and monogenic disorders (PGT-M).

Jul
23
Sponsored by
Roche

This webinar will discuss a study that set to assess the efficacy and safety of osimertinib in EGFR T790M positive non-small cell lung cancer (NSCLC) patients identified by using plasma sample and cobas EGFR Mutation test v2. This is the first prospective study to use liquid biopsy upfront to evaluate osimertinib efficacy.

Aug
25
Sponsored by
Roche

Non-small cell lung cancer (NSCLC) patients with ALK rearrangements are treated with tyrosine kinase inhibitors (TKIs), which often leads to prolonged overall survival. However, treatment resistance will almost inevitably occur, and the disease remains incurable.