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Jan 14, 2020

Biocept Target Selector for CSF

Biocept's Target Selector liquid biopsy assays are now available to physicians to evaluate patients' cerebrospinal fluid for the presence of circulating tumor cells and biomarkers for patients with breast or lung cancer suspected of brain or central nervous system metastases. The presences of such cells may indicate brain metastases. Biocept said that up to 30 percent of patients with breast cancer and up to 36 percent of patients with lung cancer will develop brain metastases.  

Jan 13, 2020

Bio-Rad Laboratories: SEQuoia

Bio-Rad Laboratories announced the launch of the SEQuoia Complete Stranded RNA Library Prep Kit for RNA-Seq library preparation. The kit uses SEQzyme, an enzyme that couples cDNA synthesis with adapter addition in a continuous synthesis reaction. It is compatible with a broad range of sample inputs and allows capture of the complete transcriptome, including short and long RNAs, in a single library prep. The kit generates cDNA libraries suitable for strand-specific next-generation sequencing on Illumina sequencers in less than four hours. It also includes access to the integrated SeqSense analysis solution to process and quality control sequencing data for all RNA biotypes in the library within a single analysis pipeline.

Jan 13, 2020

OncoCyte DetermaRx

OncoCyte has launched the DetermaRx, test for identifying early-stage lung cancer patients who may benefit from adjuvant chemotherapy after surgical resection. The test was formerly known as the Razor treatment stratification test and was being developed by Razor Genomics, which OncoCyte acquired in September. Regulators in Canada have approved the test for marketing in that country, the Irvine, California-based firm said. In the US, Florida Precision Oncology and the Leonard Cancer Institute at Mission Hospital in Mission Viejo, California have signed up as early access users of the test, OncoCyte said. It said that in a clinical study, high-risk patients identified by the test post-surgery and treated with adjuvant chemotherapy had a "significant" increase in survival rates. 

Jan 13, 2020

Sphingotec: IB10 Sphingotest PenKit

SphingoTec has launched its IB10 sphingotest penKit. The CE-IVD-marked point-of-care test for proenkephalin allows for the real-time assessment of kidney function with a blood test. The test will be made available in Europe and other geographies that accept CE-IVD certification at the end of this month to the critical care community for further clinical evaluation. It will be available for use with Sphingotec's rapid POC platform, the Nexus IB10 that uses whole-blood samples without preprocessing, requires less than three minutes of hand-on time, and delivers test results in 20 minutes. 

Jan 09, 2020

Personalis NeXT Dx Test

Personalis has launchedthe NeXT Dx Test, a next-generation sequencing panel designed to help oncologists identify potential therapies and clinical trial options for cancer patients. The assay analyzes approximately 20,000 genes in both the tumor exome and transcriptome, and includes advanced analytics to provide a diagnostic report on genetic alterations in medically important cancer genes, as well as emerging immunotherapy-related biomarkers such as microsatellite instability status and tumor mutational burden.

Jan 08, 2020

Viracor Eurofins 'Viracor TRAC'

Viracor Eurofins has begun offering its Viracor TRAC donor-derived, cell-free DNA assay for diagnosing kidney transplant rejection. The noninvasive liquid biopsy test has similar characteristics to other donor-derived cfDNA assays on the market, Viracor Eurofins said. Two ongoing prospective and one retrospective clinical trials are underway to further develop clinical data to support use of the test. The current gold standard for diagnosing kidney transplant rejection and surveillance is organ biopsy, which is both expensive and can lead to multiple complications for the patient, the firm noted. 

Jan 07, 2020

PreventionGenetics Rapid PGxome WES Test

PreventionGenetics has added the Rapid PGxome whole-exome sequencing test to its clinical testing menu. It is ideal for situations where a rapid genetic diagnosis is essential, including patients with neonatal, infantile,  or early childhood onset severe disorders, the company noted. Rapid PGxome starts at $2,290 per test and must be ordered by a qualified healthcare provider. It has a turnaround time of 14 days and, in cases with a clear positive result, a preliminary report may be issued in as few as six days.

Jan 06, 2020

Sysmex Ipsogen JAK2 DX

Sysmex has launched the ipsogen JAK2 DX reagent after the product received health insurance coverage in Japan on Jan. 1. The Kobe, Japan-based firm said that it received marketing approval for the gene testing kit that measures the JAK2V617F mutation quantitatively in December 2018. The test is used to diagnose certain hematopoietic tumors, specifically polycythemia vera, essential thrombocythemia, and primary myelofibrosis. Sysmex inked a distribution deal with Ipsogen (now part of Qiagen) in 2011 covering Japan that allows Sysmex to distribute some Ipsogen blood cancer products in that country.

Dec 16, 2019

SpeeDx: ResistancePlus MG FleXible

SpeeDx has launched the ResistancePlus MG FleXible for the GeneXpert System in Europe. The test detects Mycoplasma genitalium and markers associated with azithromycin resistance. It is now available in France and the UK, to be followed by the rest of the EU, Australia, and New Zealand. Cepheid is the exclusive distribution partner of the test through its FleXible Cartridge program for the GeneXpert System.

Dec 16, 2019

Anixa Biosciences Cchek Prostate Cancer Confirmation Test

Anixa Biosciences launched its Cchek Prostate Cancer Confirmation test, which leverages the firm's AI- and flow cytometry-based liquid biopsy platform. The Cchek PCC test will be offered as a CLIA-validated test through Anixa's partner laboratory, ResearchDx, which validated it. The test, which uses a blood draw, is meant to confirm the need for prostate biopsy by measuring a patient's immunological response to malignancy by analyzing immune system cells in peripheral blood.

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

Siemens Healthineers Enhanced Liver Fibrosis Testing Service

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. 

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.

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