Close Menu

New Products

Jan 31, 2019

Sysmex America's UN-2000

Sysmex America this week launched its UN-2000, a urine sediment analysis platform that combines flow cytometry and digital imaging to classify pathogenic cells, essentially eliminating the use of a microscope. According to the firm, the new platform's user-definable rule settings, intelligent data management with Urine Data Manager, and high-quality images produced by a digital camera, provide labs with more control over their process and analysis. The UN-2000 allows for flexible configurations that can increase throughput, as well as scalable options for upsizing and downsizing. The UN-2000 reduces the opportunity for clerical errors, lessens manual data entry, and decreases specimen-handling requirements, the firm added.

Jan 30, 2019

Bio-Rad Laboratories Liquichek Serum Indices

Bio-Rad Laboratories has launched the Liquichek Serum Indices for use as part of laboratory interference testing to monitor an instrument's ability to dtect hemolysis, icterus, and lipemia (HIL) specimen interferences in patients' samples. HIL interference can alter assay results and contribute to preanalytical variation affecting clinical chemistry testing. Liquichek Serum Indices is prepared from human-source material that resemble human samples at HIL-relevant concentrations. 

Jan 28, 2019

Biocept Target Selector Kits

Biocept has announced the availability of the first research-use-only (RUO) assay in a planned menu of kits for labs to run its Target Selector circulating tumor DNA assays in house.  The first assay being released is for high-sensitivity detection of EGFR mutations, which are among the most frequently evaluated biomarkers for lung cancer. Additional RUO test kits for other oncogene mutations are planned for launch in the future.

All will use Biocept's proprietary "switch blocker" technology, which the firm says produce industry-leading sensitivity for the detection of variants of interest. The EGFR kit and other assays can be used on a variety of analytical platforms including qPCR, Sanger sequencing, microarrays, mass-spectrometry, and next generation sequencing. 

Jan 28, 2019

SQI Diagnostics RA Test, Celiac Disease Monitoring Service

SQI Diagnostics announced its partner Microdrop has launched two at-home testing products for rheumatoid arthritis and celiac disease. The RA test measures biomarkers for the condition and provides information to patients for discussions with their docturs. Microdrop also launched a celiac disease monitoring service, which allows a patient to be continuously monitored to determine the effectiveness of their diet and treatment. The celiac monitoring service follows on the Imaware celiac screening test launched last month by Microdrop.

Jan 25, 2019

Roche Cobas Plasma Separation Card

Roche has launched the Cobas Plasma Separation Card for quantitative HIV viral load testing. The card, which received CE-marking earlier this month, is a sample collection device that takes a small amount of blood from a patient's fingertip. It simplifies blood collection and sample transportation, which is useful in areas of extreme heat and humidity. It also meets the World Health Organization's sensitivity standard of less than 1,000 cp/mL. The card is available in countries accepting the CE mark for use with the Cobas AmpliPrep/Cobas TaqMan HIV-1 and the Cobas 4800/6800/8800 HIV-1 tests.

Jan 24, 2019

Biocare Medical Valent

Biocare Medical has launched the Valent, an open, fully automated in vitro diagnostic staining platform. The system enables users to process 48 slides simultaneously, allowing for multiplexing immunohistochemistry capability. The open platform allows users to apply enzyme pretreatments, antibodies, detections, or chromogens from any source, Biocare said. 

Jan 23, 2019

Bio-Rad Laboratories qUAntify Advance Control

Bio-Rad Laboratories has launched the qUAntify Advance Control for urinalysis testing in clinical labs. The control is used to monitor the precision of laboratory urinalysis test procedures, and it contains human urine solution and offers 31 days of open vial stability for all analytes, including ketones at room temperature. Bio-Rad added that the Unity Interlaboratory Program and Unity QC Data Management Solutions are availabe for use with qUAntify Advance. 

Jan 22, 2019

Intermountain Healthcare Precision Genomics ICG100 Myeloid Malignancies Panel

Intermountain Healthcare Precision Genomics has announced its ICG100 Myeloid Malignancies Panel to help classify and diagnose multiple blood cancer types. The panel includes 63 genes and uses peripheral blood, bone marrow aspirate, extracted DNA, or fixed samples to detect faulty gene alterations through next-generation sequencing. According to the firm, the panel identifies variants in genes linked to several cancers, including acute myeloid leukemia, myeloid proliferative neoplasm, myeloid dysplastic syndrome, and myeloid dysplastic/myeloid proliferative overlap disorders. 

Jan 22, 2019

Thermo Fisher Scientific ImmunoCAP Specific IgE

Thermo Fisher Scientific has launched its ImmunoCAP Specific IgE blood test for Ara h6. The test is for use by medical providers to better determine which patients may be at risk for life-threatening sensitivity to the Ara h6 protein component in peanuts. The test has been cleared by the US Food and Drug Administration for in vitro diagnostic use. The ImmunoCAP line of tests include assays for cross-reactive carbohydrate determinants and profilins, allergens that are contained in various plants, pollens, and foods. 

Jan 17, 2019

XIFIN's VisualStrata

XIFIN this week launched VisualStrata, a precision medicine informatics platform that curates and visualizes diagnostic, clinical, and financial data documenting patients' journey through diagnosis and treatment to outcomes. The firm said the new platform provides healthcare professionals with deeper insights into optimal disease treatments and can help drive personalized care decisions. VisualStrata seamlessly integrates with most electronic medical record systems and electronic health record systems, as well as with other products that collect patient clinical, diagnostic, and financial data. 

It also supports organizational objectives such as clinical improvement initiatives, efficiency programs, physician engagement, and population health efforts, the health information technology firm said.

Jan 15, 2019

Roche uPath Digital Pathology Software

Roche has introduced uPath, an enterprise software system for digital pathology that replaces the previous Ventana Virtuoso software from Roche subsidiary Ventana Medical Systems. The new uPath system promises to decrease image rendering times and integrate automated image analysis functions, according to the company. In developing uPath, Roche acquired Leeds Virtual Microscope technology from the University of Leeds, U.K., and the Leeds Teaching Hospitals NHS Trust in the UK.

Jan 09, 2019

Sclero-Smart

Specialty biotech firm Gemelli Biotech has launched Sclero-Smart, a blood-based test that measures levels of anti-vinculin, an autoantibody which has been found to be elevated in sclerodema patients and associated with gastrointestinal complications. The finding of the association suggests a link between sclerodema and the gut microbiome, the Los Angeles-based firm said, and could lead to new microbiome-related diagnostic tools and therapeutics for the disease. The Sclero-Smart, which uses an ELISA format measures anti-vinculin levels in patients with systemic sclerosis and sclerodema. 

Jan 08, 2019

Yourgene Sage 32 Plex

Yourgene Health has launched the Sage 32 plex test, a high-throughput noninvasive prenatal testing and analysis solution for clinical laboratories. It runs on Thermo Fisher Scientific's Ion Torrent sequencing platform and allows 32 samples to be processed in parallel. The test, which will be available internationally, has improved performance due to workflow enhancements and upgraded analysis methods. Yourgene plans to launch a CE-IVD-marked version of the library preparation kit for the Sage 32 plex workflow in the coming months. The Sage test differs from Yourgene's other NIPT, the Iona test, in that it screens for a wider range of conditions, including trisomies 21, 18, and 13; sex chromosome aneuploidies; and clinically relevant microdeletions. The analysis uses a cloud-based bioinformatics solution called Sage Link.

Dec 21, 2018

Contextual Genomics 'Find It' and 'Follow It' Assays

Contextual Genomics, a Vancouver, Canada-based cancer genomics company, said that it has completed development of two new products: an improved version of its Find It hotspot panel for detection of genomic mutations in solid tumour cancers; and its Follow It hotspot panel for detection of the same genomic mutations in blood plasma.

The Find It panel now screens for 146 somatic genome alterations found in solid tumor cancers to identify optimal therapeutic treatments and recognize acquired drug resistance mutations. The assay is supported by Contextual's cloud-based genome analysis engine (CGIRP).

The Follow It panel screens for cell-free circulating tumour DNA in plasma, and is designed to  be used in patients with widespread metastatic disease at diagnosis and as a time series monitoring tool to read out tumor burden and treatment resistance. Follow It will screen for all of the same somatic genome alterations as Find It and can be used to follow disease progression for patients, including those whose tumors were initially tested with Find It.

Dec 21, 2018

DiaSorin Molecular Primer Pairs

DiaSorin Molecular has introduced three new primer pairs for Legionella species, Chlamydophila pneumoniae, and Mycoplasma pneumoniae, which can be used in laboratory-developed tests. The firm noted that it now offers more than 55 analyte-specific reagents.

Dec 20, 2018

Viracor Eurofins 16S NGS Bacterial Meningitis Test

Viracor Eurofins recently launched its 16S Next-Generation Sequencing Bacterial Meningitis test. The assay amplifies the 16S gene utilizing PCR, followed by NGS to identify and report the bacterial pathogen in a patient's CSF sample. The assay was validated to include the most common bacterial pathogens associated with meningitis: Streptococcus pneumoniae, Neisseria meningitidisHaemophilus influenzaeListeria monocytogenesStreptococcus agalactiae (Group B Strep), and Escherichia coli, as well as other less common pathogens that may be clinically important in immunocompromised patient populations (HIV-positive, solid organ transplant, or hematopoietic cell transplant patients). Physicians will receive test results for difficult-to-diagnose immunocompromised patients within three business days from specimen receipt, the company said.

Dec 14, 2018

Microbiologics Group A Streptococcus and Respiratory Control Panels

Microbiologics has launched its Group A Streptococcus and Respiratory Panels, as well as test meothods to help clinical laboratories deliver accurate results during cold and flu season. The panels include features such as multiplexed pellets, swabs that mimic patient sample processing, and room temperature storage. 

Dec 11, 2018

ZeptoMetrix Pneumonia Verification Panels

ZeptoMetrix has released two pneumonia verification panels for molecular quality control, the NATrol Pneumonia Panel-Atypical Bacteria & Viruses and NATrol Pneumonia Panel-Quantifiable Bacteria. The Buffalo, New York-based company designs, develops, and markets solutions for the infectious disease diagnostics space. 

Dec 10, 2018

SQI Imaware Celiac Disease Test

SQI Diagnostics has launched the Imaware home-based test for celicac disease developed by Microdrop. The test is run on SQI's automated system. Other Imaware tests running on the SQI platform are expected to launch in 2019, including a home-based test for rheumatoid arthritis, SQI said.

Dec 03, 2018

Insight Genetics Insight TNBCtype

Insight Genetics has launched Insight TNBCtype, a new test for categorizing triple negative breast cancers (TNBC) into distinct molecular subtypes. Offered through its CLIA-certified and CAP-accredited lab, Insight Molecular Labs, the new test is intended to help advance prospective clinical trials of targeted therapies for TNBC patients.

TNBC, which represents up to 15-20 percent of all breast cancers, is an aggressive disease, characterized by an absence of ER, PR, and HER2 expression. Insight TNBCtype is based on a proprietary algorithm that uses gene expression data from next-generation sequencing to generate five molecular subtypes (BL1, BL2, LAR, MSL and M), as well as a complementary immunomodulatory (IM) classifier that may help predict response to immuno-oncology therapies. 

Nov 30, 2018

Qiagen QiaScreen HPV PCR Test

Qiagen announced the European launch of its QiaScreen HPV PCR test, a CE-IVD marked molecular diagnostic assay for 15 recognized high-risk genotypes of human papillomavirus associated with cervical cancer. The assay is designed to detect a range of DNA targets within the E7 region of the HPV virus, providing the flexibility of PCR without the risk of false positives due to L1 deletion, Qiagen said. The clinical performance of the assay was tested using nearly 1,600 samples from the Valgent-3 panel, and was reported to have a clinical sensitivity and specificity to CIN3+ of 97.3 percent and 89.0 percent, respectively. The assay is designed for use on either clinician-collected or self-collected specimens, and it has been validated on Qiagen's Rotor-Gene Q MDx system. Qiagen also intends to offer a version of the test on the NeuMoDx 96 and 288 molecular systems in the future for customers desiring higher-volume testing and full integration.

Nov 27, 2018

Roche Ventana pan-TRK Assay

Roche has launched its new Ventana pan-TRK Assay, which detects tropomyosin receptor kinase proteins in cancer. According to the firm, laboratories can now identify wild-type and chimeric fusion proteins by detecting the TRK C-terminal region. Researchers can run the assay on Roche's benchmark series of IHC/ISH automated staining instruments. 

Nov 27, 2018

Roche Diagnostics LabOPS and Dx Optimization

Roche Diagnostics has launched two new apps aimed at helping hospital labs improve efficiency and effectiveness. LabOPS helps labs and hospitals access their own data more effectively and make fact-based decisions around the operational and financial processes of their institutions. It is intended to reduce waste. LabOPS is available in five languages: English, French, German, Spanish and Portuguese. Dx Optimization offers data-based insight to optimize physician ordering protocols and improve decisions made around clinical effectiveness. The app can identify over and under ordering of a test, which can increase costs and decrease quality of care. It is available in English for the US and Canada.

Nov 09, 2018

Proteomics International PromarkerD

Proteomics International has launched the new PromarkerD immunoassay kit following the completion of production of key antibody reagents. The new kit will be used to target new commercialization deals in Japan and India. PromarkerD is for predicting the onset of diabetic kidney disease and can be used by pathology labs. 

Nov 08, 2018

Hologic Panther Fusion Open Access Functionality

Hologic has introduced an Open Access functionality that will allow CLIA-certified laboratories to develop laboratory developed tests to run on its fully automated Panther Fusion platform. Labs will be able to run their LDTs simultaneously with commercially available IVD assays, and results will release automatically to laboratory information systems.

The Open Access functionality is enabled by the new myAccess software, which is designed to help laboratories create protocols, analyze data, set thresholds, and interpret results, Hologic said.

Pages