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Aalto Bio Reagents Yellow Fever Monoclonal Antibodies

Jan 31, 2017

Aalto Bio Reagents announced the availability of its yellow fever monoclonal antibodies for diagnostic test manufacturers, vaccine developers, and researchers globally. The monoclonal antibodies are raised against cell-culture derived viral lysate from strain 17D. The yellow fever antibodies complement the firm's portfolio of recombinant proteins and antibodies for chikungunya, dengue, and Zika virus diagnostic tests.

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Nov 14, 2019

Grifols AlphaID

Grifols has lunched the AlphaID, a cheek swab for use by doctors to screen patients with chronic obstructive pulmonary disease for alpha-1 antitrypsin deficiency, a rare, life-threatening genetic condition. Grifols said the swab is completely free, "from ordering to results," and leverages a US Food and Drug Administration-approved genotyping assay to screen for the 14 most prevalently reported genetic mutations associated with the condition, including the S,Z,F, and I alleles, as well as rare and null alleles. 

Nov 12, 2019

Hunan Agen Lab PD-L1 LDT Service

Singapore-based Biolidics said its laboratory partner, Hunan Agen Medicine Laboratory Technology, has launched a commercial laboratory-developed testing service in China using Biolidics' ClearCell FX1 System and CTChip FR1 biochip for testing of PD-L1 status in cancer patients. In March, Hunan Agen Lab began offering an LDT service related to circulating tumor cells. According to a Biolidics spokesman, the earlier service was for post-treatment monitoring and prognosis of patients, while the service launched now includes treatment selection. Biolidics was previously called ClearBridge Biomedics and changed its name in conjunction to listing on the Singapore Exchange. 

Nov 05, 2019

Paragon Genomics CleanPlex CFTR Panel

Paragon Genomics this week introduced the CleanPlex CFTR Panel for cystic fibrosis testing. The panel uses the company's CleanPlex target enrichment technology for a multiplex PCR-based targeted sequencing assay to evaluate somatic and germline variants in the CFTR gene. It covers all exons of the gene and includes mutations recommended by the American College of Medical Genetics and Genomics.

Nov 01, 2019

Genome Medical's Genome Care Delivery

Genome Medical, a telegenomics technology and services company, has launched Genome Care Delivery, a cloud-based platform that provides hospitals, health systems, and employers virtual access to a nationwide network of clinical genetics specialists in order to expedite and facilitate the delivery of genetic expertise. The platform is initially focused on oncology and reproductive health, and is intended to deliver education, engagement, and access to genetic experts for virtual visits and provider-to-provider consults, as well as genetic wellness assessment and screening for population health management, the company said. Features include curated content, adaptive videos, webinars, online assessment tools, virtual care visits with genetic specialists, personalized recommendations regarding genetic testing, and clinical action plans based on genetic test results and medical management guidelines.

Oct 31, 2019

Thermo Fisher Scientific Oncomine Comprehensive Assay Plus

Thermo Fisher Scientific has launched the Oncomine Comprehensive Assay Plus for the detection of targeted and immuno-oncology biomarkers. The assay, designed for solid tumors, covers more than 500 genes and enables analysis of both DNA and RNA in a single workflow. It detects single nucleotide variants, indels, copy number variants, gene fusions, and splice variants and is suitable for microsatellite instability (MSI) and tumor mutational burden (TMB) assessment. The assay requires 1 ng DNA/RNA input and fits seamlessly into existing Thermo Fisher Ion Chef and Ion GeneStudio system workflows.

Oct 31, 2019

Yourgene Flex Analysis Software

Yourgene of Manchester, UK, has launched the Yourgene Flex Analysis Software to support the company's plans to develop next-generation sequencing-based in vitro diagnostic products with partners and research collaborators in industry. The software platform builds on the company's Iona software and will also be deployed internally to support Yourgene's internal product development pipeline in reproductive health and oncology. Its components allow for sequence data to be read, filtered, and analyzed, and to generate bespoke clinical test reports. All elements of the software are developed to standard ISO/IEC 62304, which supports in vitro diagnostic regulatory submissions.

Oct 29, 2019

DxTerity Diagnostics IFN-1 Test

DxTerity Diagnostics has launched the IFN-1 Test for determining a systemic lupus erythematosus patient's type 1 interferon status and the risk of progressing to lupus nephritis. The firm launched the test after releasing results of a longitudinal clinical study with the Oklahoma Medical Research Foundation, to be presented on Nov. 11 at the American College of Rheumatology annual meeting in Atlanta. The test, DxTerity said, is currently being used to select and monitor patients for SLE clinical trials. While therapies targeting IFN-1 have shown promise in Phase II clinical studies, they have had disappointing results in Phase III randomized trials. The ability to select patients who overexpress IFN-1, based on RNA profiling, is seen as crucial for the future success of clinical trials, DxTerity said. The IFN-1 assay a gene expression module contained within the company's Modular Immune Profile assay, which was developed to measure the relative gene expression of immune system-related genes.

Oct 17, 2019

Thermo Fisher Scientific Acrometrix BCR-ABL panel

Thermo Fisher Scientific has launched its Acrometrix BCR-ABL Panel. According to Thermo Fisher, the panel is intended to be used as an external control panel for analytical validation of BCR-ABL test methods. The firm said that the research-use-only panel can monitor assay performance at every clinical stage due to its expanded dynamic range.

Oct 15, 2019

HTG Molecular HTG EdgeSeq Autoimmune Panel

HTG Molecular said it is now taking orders for its new HTG EdgeSeq Autoimmune Panel, which it expects to commercially launch in kit form or as a service at the end of October. The firm said it has designed the panel to address questions around autoimmune disorders, as well as for examining immune system dysfunction, discovering new biomarkers, and discovering predictive signatures of drug responses in the autoimmune space. 

Oct 15, 2019

LGC Maine Standards Validate LP2 Linearity and Calibration Verification Kit

LGC Maine Standards launched the Validate LP2 linearity and calibration verification kit for Roche Cobas analyzers. The kit, which is in a human serum matrix, is used to assess apoliprotein A and apoliprotein B. Each kit offers five concentrations covering the reportable range and can be used to augment daily QC and assist with fulfilling various quality control requirements for linearity and calibration verification under CLIA '88, the College of American Pathologists, COLA, Joint Commission on Accreditation of Healthcare Organizations, Joint Commission International, and ISO 15189, LGC Maine said. 

Oct 14, 2019

Predictive Laboratories FertilityDX

Predictive Laboratories launched FertilityDX, a genetic testing service that allows physicians to tailor fertility treatments. The test provides information in three areas, the firm said — causes of infertility, risks of pregnancy complications, and risks for serious genetic conditions in the offspring. As part of the service patients are provided pretest counseling, and physicians received an easy-to-understand final report, as well as access to genetic consultants. 

Oct 14, 2019

PerkinElmer PG-Seq Rapid Non-Invasive Preimplantation Genetic Testing Kit

PerkinElmer launched the PG-Seq Rapid Non-Invasive Preimplantation Genetic Testing for Anueploidy kit, which tests spent embryo culture media for chromosomal abnormalities during in vitro treatment. Preimplantation genetic testing for aneuploidiy is used to identify viable embryos and has typically involved a biopsy by creating an opening in the outer coating prior to removal and testing a few cells. Recent studies have demonstrated, however, that an embryo releases small amounts of DNA into the culture media in which it is growing, allowing for the surrounding fluid to be genetically tested. PerkinElmer's kit tests the spent embryo culture to detect aneuploidies and structural rearrangements, including unbalanced translocations and segmental errors.

Oct 11, 2019

Sema4 Expanded Carrier Screening

Sema4 has launched a larger Expanded Carrier Screen for family planning with personalized residual risk.

The test analyzes 502 genes associated with clinically relevant conditions, up from 283 genes, to cover more rare diseases. The test detects more high-risk pregnancies and identifies up to 30 times more carrier couples, Sema4 CEO Eric Schadt said in a statement. It also incorporates low-pass genome analysis to detect ancestry markers that to refine the accuracy of results.

Oct 10, 2019

Predictive Laboratories ARTguide Test

Salt Lake City, Utah-based Predictive Laboratories has commercially launched its ARTguide DNA-based blood test, which examines the risk for endometriosis and other genetic causes of infertility in women. According to the firm, the test identifies hundreds of genetic markers of endometriosis and 80 other additional mutations causing conditions that may impact fertility.  

Oct 10, 2019

Co-Diagnostics Vector Smart ZDC Test

Co-Diagnostics has commercially launched its Vector Smart ZDC test, which is used to identify the presence of Zika, dengue, and chikungunya in mosquito populations. The firm said that its line of Vector Smart PCR products are validated using extractions from mosquito samples to reduce the possibility of a false negative result due to improper extraction.