New Products

Jun 19, 2018

GenomeDx Biosciences, Pathnostics Guidance test

GenomeDx Biosciences and Pathnostics have launched the Guidance test for patients with simple cystitis, recurrent, persistent or complicated urinary tract infections, prostatitis, and interstitial cystitis. The test is performed by Pathnostics and distributed by GenomeDx urologists. Guidance is a rapid diagnostics test for personalizing treatment options by identifying 42 pathogens. It also determines antibiotic sensitivity of the pathogens and assesses the presence of antibiotic-resistant genes. Result are available 24 to 48 hours after a patient's specimen arrives at the lab. 

Jun 14, 2018

Now Diagnostics First To Know Pregnancy Test

Now Diagnostics launched its over-the-counter First To Know finger-stick pregnancy test in Italy, making it the first OTC, blood-based pregnancy test for sale in the EU. The test is available in pharmacies in Italy through an exclusive distribution agreement with Welcome Pharma. Now Diagnostics CEO Gianni Furino said the company plans to expand the availability of First To Know throughout the EU in the coming months. The test is not US Food and Drug Administration-cleared for OTC sale or for home use in the US. 

Jun 14, 2018

Agilent In Situ Hybridization Probes

Agilent Technologies released a range of new probes for in situ hybridization. The probes address the need to cleanly and accurately interpret data from fluorescence in situ hybridization and chromogenic in situ hybridization, Agilent said. The new Agilent SureFISH probes include Break-Apart: MALT1, BCL2, BCL6, CCND1, MYC, IGH, Dual Fusion: IGH/CCND1, IGH/MYC, and IGH/BCL2. The new CISH probes include (ASR) EBER RNA CISH and Kappa and Lambda mRNA CISH probes.

Jun 12, 2018

Agilent Chromogenic In Situ Hybridization With Tumor Sample Staining

Agilent Technologies announced the release of a new accessory kit that enables the company’s fully automated Dako Omnis tumor sample staining system to analyze tissue samples using three different techniques simultaneously. With the new kit, the system can process immunohistochemical, fluorescence in situ hybridization, and chromogenic in situ hybridization assays. All tests for a specific case can be run simultaneously, and a clinician can get results in a "greatly reduced timeframe, enabling better patient case management," Agilent said.

Jun 11, 2018

Molecular Health Guide Version 3.0

Molecular Health has released version 3.0 of its Molecular Health Guide software platform for precision medicine. According to the company, the new release offers improved biomarker classification and now supports Human Genome Variation Society nomenclature, allowing users to incorporate other diagnostic test results into MH Guide reports, which combine patient-specific molecular data with biomedical knowledge to assist physicians in choosing treatments. MH Guide is registered as an in vitro diagnostic device in the European Union.

Jun 07, 2018

Curetis Unyvero System, Lower Respiratory Tract Infection Cartridge

Curetis has announced the US commercial launch of its molecular diagnostic Unyvero System and the Unyvero LRT Application Cartridge, a test cartridge to detect lower respiratory tract infections. The cartridge, which was cleared together with the system by the US Food and Drug Administration earlier this year, covers more than 90 percent of infection cases of hospitalized pneumonia patients, detecting pathogens and genetic resistance markers directly from aspirate samples in less than five hours.  

Jun 05, 2018

Grifols Daratumumab Neutralization Test

Grifols has added a daratumumab neutralization testing service to its menu offered at the Grifols Immunohematology Center laboratory in San Marcos, Texas. The test enables complete antibody screening and identification in pretransfusion testing of patients using daratumumab, a monoclonal antibody for the treatment of multiple myeloma. The test is based on a soluble recombinant human CD38 that neutralizes the therapy present in plasma and eliminates its interferences with routine pretransfusion testing, the company said. 

Jun 05, 2018

Novacyt Infectious Mononucleosis Immunoassay

Novacyt's protein diagnostics division, Lab21, has launched a new product for the diagnosis of infectious mononucleosis (IM), or glandular fever. The product, PathFlow Mononucleosis, is a qualitative lateral flow immunoassay for the detection of IM antibodies in the blood. IM is frequently misdiagnosed as streptococcal pharyngitis, a bacterial infection, due to common clinical presentation of the diseases at onset. However, Epstein–Barr, a virus, causes infectious mononucleosis, so it doesn't respond to antibiotic treatment. PathFlow Mononucleosis provides a rapid and effective differential diagnosis to patients with IM over streptococcal pharyngitis, Novacyt said.

Jun 04, 2018

OmniSeq Advance

Roswell Park Comprehensive Cancer Center subsidiary OmniSeq and the Laboratory Corporation of America have launched a molecular cancer assay, OmniSeq Advance. The test involves next-generation sequencing and immunohistochemistry to assess specific genomic alterations, tumor mutational burden, microsatellite instability, the tumor microenvironment, and markers associated with immunotherapy. LabCorp will distribute the test.

May 31, 2018

Abbott Afinion 2 Analyzer

Abbott has launched the Afinion 2 analyzer, a new generation of its Afinion system, in the US. The Afinion 2 provides patients with health information that they can discuss with their providers during a single visit, Abbott said. It is a compact rapid, multi-assay platform that streamlines and simplifies the delivery of results at the point of care for measurements of hemoglobin A1c (HbA1c) and albumin-to-creatinine ratio (ACR), the firm said. Healthcare professionals receive results in three minutes for HbA1c and five minutes for ACR, and can thus dedicate more time to counseling patients within a single office visit, Abbott said. The new analyzer is already available with HbA1c, ACR, C-reactive protein, and a lipid panel in select markets outside the US.

May 30, 2018

LAM IvyGene Test

Laboratory for Advanced Medicine has launched its non-invasive, epigenetics-based, laboratory-developed IvyGene test. IvyGene is designed to detect DNA methylation patterns consistent with the presence of cancer and provide quantitative data about the presence of cancer at the time of testing. It is intended to be used in conjunction with other diagnostic and confirmatory tests, including mammograms, PET scans and biopsies. To date, LAM said that the assay has been validated to detect four cancers: breast, colon, liver and lung, though the company has not yet published clinical validation results. 

May 17, 2018

Precipio KRAS Liquid Biopsy Kits for Pancreatic Cancer

Precipio has launched two new research-use only ICEme kits for the detection of mutations in KRAS Exons 2 and 3 in pancreatic cancer. The kits use the company's proprietary ICE-COLD PCR liquid biopsy technology and are available for both qPCR and Sanger sequencing platforms. According to Precipio, its non-invasive, low-cost enrichment technology is well-suited for laboratories developing screening and monitoring tests. The kits will be priced at approximately $100 per specimen.

May 16, 2018

Veracyte Afirma Xpression Atlas

Veracyte has launched its Afirma Xpression Atlas test for thyroid cancer. The test uses RNA sequencing to analyze 761 DNA variants and 130 RNA fusions in over 500 genes that have been linked to thyroid cancer. The test's aim is to provide information to help clinicians make surgery and treatment decisions for patients who have thyroid nodules.

May 15, 2018

Invivoscribe LymphoTrack Dx TRB Assay

InvivoScribe Technologies has released its LymphoTrack Dx TRB Assay for the Illumina MiSeq platform, a CE-marked next-generation sequencing kit for in vitro diagnostic use. The assay completes the menu of Invivoscribe's CE-marked clonality assays on the MiSeq, enabling small and large laboratories to identify and track clonal rearrangements.

May 14, 2018

Interpace Diagnostics ThyGeNext

Interpace Diagnostics said it is launching ThyGenNext, a mutational panel for indeterminate thyorid nodules, at the American Association of Clinical Endocrinologists annual meeting this week. ThyGeNext builds on the company's ThyGenX panel (launched in August 2014) by adding numerous molecular markers, gene mutations, and RNA fusions, resulting in a more comprehensive set of indicators to identify malignant or benign nodules and ascertain aggressiveness and other characteristics. Specifically, it uses next-generation sequencing to identify more than 150 genetic alterations assciated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid cancer.

May 14, 2018

Oncimmune EarlyCDT-Liver

Oncimmune launched the EarlyCDT-Liver test for hepatocellular carcinoma carcinoma in the US. The test has a specificity of 97 percent and is the second test launched by Oncimmune based on the EarlyCDT technology. EarlyCDT-Liver is a simple blood test and complementary to imaging-based testing. It can aid in stratifying high-risk patients whose diagnosis is indeterminate following ultrasound and CT or MRI. It can also aid in the risk assessment and early detection of HCC in high-risk patients with hepatic lesions less than 1 cm, Oncimmune said. The company has begun CE marking for a kit version of the test, which is expected to be completed by the end of Q1 2019. 

May 14, 2018

Bioprognos OncoCUP Dx

Spanish biotech firm Bioprognosis introduced a new version of its OncoCUP Dx, a noninvasive test for identifying cancers of unknown primary diagnosis. The test was developed and tested "in collaboration with few quick diagnosis units," an outpatient model for diagnostic workups that are used in Europe. QDUs are an alternative to hospitallizations and are designed to reduce delays in diagnosing potentially severe diseases. Among the cancers that OncoCUP Dx can identify are bladder cancer, breast cancer, colorectal cancer, liver cancer, and non-small cell lung cancer, Bioprognosis said. 

 

May 10, 2018

Beckman Coulter DxH 500 Software

Beckman Coulter has launched software to support new and exisiting DxH 500 hematology analyzers. The version 2 software upgrade allows small-volume clinical labs to access a proprietary dynamic-gating method for improve flagging, a quality control menu, and other things. The improvements allow labs to deliver fast, accurate results to physicians and patients with greater efficiency, Beckman Coulter said. 

May 09, 2018

Karius NGS Pathogen Test

Karius has launched a quantitative version of its next-generation sequencing-based test that identifies microbial cell-free DNA in blood. According to the company, the test can identify DNA from more than 1,000 pathogens including bacteria, DNA viruses, fungi, mold, and protozoa.

May 08, 2018

Intermountain Healthcare RxMatch Comprehensive Panel

Intermountain Precision Genomics Core Laboratory said its RxMatch Comprehensive Panel has expanded to 97 gene targets from 36. Originally launched last September as an anti-depressent panel, it now includes opioids, statins, immunosuppresants, anti-depressants, and others. Patients provide a DNA sample with a cheek swab collected in a physician's office. Results are available within about a week. Intermountain Precision Genomics Core Laboratory is part of Intermountain Healthcare.

May 02, 2018

PredicineATLAS

Predicine has launched a new liquid biopsy panel called PredicineATLAS, which covers 600 genes and offers a readout of patients tumor mutational burden to help inform and assess immuno-oncology treatment.

The assay will be available first for research use only though an early access program, but the company aims to at some point add a CLIA-certified version as well.

May 01, 2018

Beckman Coulter's DxH 900

Beckman Coulter has commercially launched its DxH 900 hematology analyzer. The new instrument is aimed at mid- to high-volume clinical labs performing complete blood count and white blood cell differential tests. The firm said the DxH 900 offers high-resolution analysis of cells in their near-native states, providing a precise cellular assessment for red blood cell, platelet, and white blood cell test results on the first pass. 

The DxH 900 is now available for sale in Europe, the US, Canada, Australia, and New Zealand. 

Beckman Coulter, which is owned by Danaher, said the analyzer is a complement to its DxH 520 system.

Apr 30, 2018

Streck, Diesse Diagnostica Cube 30 Touch

Streck and Diesse Diagnostica have launched the Cube 30 Touch, an automated instrument for high-volume erythrocyte sedimentation rate testing in EDTA tubes. Streck said it is the exclusive distributor of the Cube 30 Touch in the US and Canada. The instrument produces ESR results directly from EDTA tubes without consuming the patient sample. It is also compatible with standard 4.0 mL K2EDTA tubes. Results can be achieved in 20 minutes. 

Apr 26, 2018

Agilent In Situ Hybridization Probes

Agilent Technologies introduced a number of in situ hybridization probes, including the EBER RNA CISH, Kappa, and Lambda mRNA CISH probes for Dako Omnis. Additionally, a manual IQFISH panel for lymphoma was launched following its CE marking. 

The EBER RNA CISH, Kappa, and Lambda mRNA CISH releases increase the diagnostic capabilities of the Dako Omnis instrument, which can now be used to simultaneously run tests involving CISH, FISH, and immunohistochemistry. Meanwhile, the IQFISH panel is a set of oligonucleotide-based FISH probes for detecting rearrangements involving the MYC, CBL2, BCL6, MALT1, CCND1, and IGH genes. The probes are for use on formalin-fixed, paraffin-embedded tissue sections, Agilent said, adding they are available in break-apart and dual-fusion methodologies.

Apr 25, 2018

HiberGene HG Pneumo/Meningo Combo

HiberGene has launched the HG Pneumo/Meningo Combo test for the rapid detection of meningococcal and pneumococccal meningitis. The loop-mediated isothermal amplification-based test covers up to 90 percent of cases of bacterial meningitis and provides results in less than one hour, compared to traditional microbiological methods which can take between 24 and 48 hours, the company said. Samples are incubated and read on HiberGene's HG Swift instrument. 

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