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WaveSense nRichDx

Dec 02, 2016

WaveSense has launched the nRichDx system for bulk isolation of target cells and nucleic acids from liquid biopsies. The new system uses WaveSense's proprietary paramagnetic bead technology to capture circulating tumor cells and cell-free DNA or RNA in quantities sufficient for subsequent next-generation sequencing or PCR analysis. The system can capture cells and nucleic acids from an array of sample types including blood, urine, and bone marrow, and is specifically designed and optimized for high-volume, low-yield specimens, the company said.

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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.

May 19, 2020

Aalto Bio Reagents Recombinant SARS-CoV-2 Spike Proteins

Dublin-based Aalto Bio Reagents has released a range of recombinant SARS-CoV-2 spike (S) proteins for diagnostic test manufacturers, vaccine developers, and researchers globally. The S protein is the main antigenic component that is responsible for inducing host immune responses and neutralizing antibodies, making it the principal focus of therapeutic and vaccine design for COVID-19. When used solely or in combination with Aalto's new insect-derived nucleocapsid protein (N), the company's S1-S2 chimeric glycoprotein has demonstrated excellent reactivity in ELISA for the detection of IgA, IgG and IgM antibodies against SARS-CoV-2, the company said.

Jul
23

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.