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Siemens Healthineers Enhanced Liver Fibrosis Testing Service

Nov 25, 2019

Siemens Healthineers has launched its Enhanced Liver Fibrosis testing service in the US. The service is provided by the Siemens Healthcare Laboratory unit that can test samples submitted from all states in the US, Washington, DC, and Puerto Rico, excluding New York state. The test uses a small blood sample from a patient and provides a unitless numeric score that combines the quantitative measurements in a serum sample of three markers of liver fibrosis — hyaluronic acid, amino-terminal propeptide of type III procollagen, and tissue inhibitor of metalloproteinase. The score can help identify chronic liver disease patients, including those with non-alcoholic fatty liver disease, and stratify individuals at risk of progressing to liver-related events. Siemens noted that the test is not approved by the US Food and Drug Administration. 

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Dec 09, 2019

ELITechGroup Macroduct Advanced Sweat Collection System

In vitro diagnostic equipment and reagent company ELITechGroup has launched its Macroduct Advanced Sweat Collection System in Canada. The system further standardizes pilocarpine iontophoresis and sweat collection and has a touch screen interface with step-by-step graphical instructions, the company said. The new system also has revised electrode shapes to make it easier to work with neonates and toddlers. 

The company's other products include the Webster Sweat Inducer and the Macroduct Sweat Collection System. 

Dec 04, 2019

Quadrant Biosciences Clarifi ASD

Quadrant Biosciences has launched Clarifi ASD, an epigenetic test designed to aid in the diagnosis of autism spectrum disorder in children 18 months through six year of age. Quadrant said the test is based on regulatory RNAs and microbes in the saliva, and is the result of seven years of research in collaboration with SUNY Upstate Medical University and Penn State College of Medicine. Clarifi is a prescription-only, laboratory-developed test that is intended to be used as an additional tool to standard practices and only for children with a clinical suspicion of ASD, the company said. It is available in all states except New York.

Dec 02, 2019

Versiti P-Selectin Expression Assay for Heparin-Induced Thrombocytopenia

Versiti has launched its P-Selectin Expression Assay (PEA) for testing patients suspected of having heparin-induced thrombocytopenia (HIT).

HIT is an immune-mediated drug interaction that is difficult to diagnose. When left untreated, it can progress to thrombosis, the development or growth of blood clots within a blood vessel.

Compared to a current test for detecting HIT, the serotonin release assay, the PEA can detect more patients with HIT antibodies, Versiti said. Its PEA test has a turnaround time of less than 24 hours.

Nov 27, 2019

Devyser HBOC Kit for Hereditary Breast, Ovarian Cancer Testing

Swedish genetic test developer Devyser has launched the HBOC kit for hereditary breast and ovarian cancer testing. The kit is based on Devyser's proprietary next-generation sequencing library prep technology, and provides targeted sequencing of 12 genes in which mutations are associated with an increased risk of developing breast and ovarian cancer. The company said that the workflow takes less than 45 minutes. The HBOC kit is part of Devyser's NGS Oncology suite, complementing the company's BRCA kit that enables simultaneous screening of mutations in the BRCA1 and BRCA2 genes. The new kit is available in the EU and through Devyser distributors in several countries in the Middle East, Southeast Asia, China, South America, and Africa. Customers in countries in which Devyser does not have distributors currently (e.g. the US and Canada) can self-import the assay, a company spokesperson said.

Nov 25, 2019

IGeneX Broad Coverage Ab Lyme Disease, Tick-Borne Relapsing Fever Assays

IGeneX has launched two assays for the pathogens that can cause Lyme disease and tick-borne relapsing fever. The tests use the firm's Broad Coverage Ab (BCA) technology to detect both IgM and IgG antibodies against multiple species and strains of Lyme Borreliae and TBRF Borreliae in blood serum. They can detect species and strains native to North America, Europe and Australia, and the firm said they are simpler and more cost-effective than standard two-tier testing using ELISA. The testing is offered as a service from the firm's Milpitas, California lab at a cost of $195 per test, with physicians required collect test specimens using IGeneX collection kits.

Nov 22, 2019

Biocept TRK Assay

Biocept said it has launched a new assay for detection of TRK proteins in circulating tumor cells, intended to help inform physicians of patients' NTRK fusion status, an actionable biomarker that can be used to qualify patients for treatment with TRK inhibitor therapies.

The launch brings the company's CLIA lab test menu to 20 assays, including a variety of other single-gene tests analyzed in either circulating cell-free DNA or CTCs, and a next-gen sequencing panel test for lung cancer biomarkers.

Nov 19, 2019

HTG Molecular Diagnostics EdgeSeq Reveal V 2.0

HTG Molecular Diagnostics has released its HTG EdgeSeq Reveal data analysis software, version 2.0. The Tucson, Arizona-based firm said that the new software contains enhanced functionality, allowing rapid data analysis from the HTG EdgeSeq Autoimmune Panel.

Nov 18, 2019

Summit Diagnostics AutoUA

Summit Diagnostics has launched its AutoUA urinalysis solution. The Salem, New Hampshire-based company released its total solution package that includes qualitatitve urine chemistry reagents, a benchtop analyzer, instrument service, and leasing services targeted to physician office markets. The system provides a panel of up to 30 results on a single random urinalysis using less than 150 microliters of urine in matters, Summit Dx said. Additionally, the firm launched the AutoUA reagent-only option, which is focused on "major clinical analyzer placements that can easily adapt and implement processes and protocols on [customers'] current in-lab analyzers," a spokeman for the firm said in an email. 

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.

Jan
28
Sponsored by
Sophia Genetics

This webinar will discuss how Moffitt Cancer Center has implemented a new capture-based application to accurately assess myeloid malignancies by detecting complex variants in challenging genes in a single experiment.