New Products

Oct 16, 2017

IGeneX Lyme Disease and Tick-Borne Relapsing Fever Tests

IGeneX, a CLIA and New York-approved reference lab, launched three new tests for diagnosing Lyme disease and Tick-Borne Relapsing Fever, also known as TBRF. The Lyme ImmunoBlot IgM and IgG tests are inclusive for detection of most species of B. burgdorferi, which is one of the two groups of Borrelia that causes disease. The TBRF ImmunoBlots IgM and IgG tests are designed to detect antibodies to specific antigens of TBRF Borrelia in human serum, specifically antibodies to B. hermsii, B. miyamotoi, B. turicatae, and B. coriaceae. The Lyme IGXSpot test is an enzyme-linked immunoSpot, also known as an ELISPOT assay, which detects human T cells reactive to B. burgdorferi specific antigens.

Oct 16, 2017

Theradiag, Miraca Life Sciences Therapeutic Drug Monitoring

In vitro diagnostics and theranostics firm Theradiag said its partner Miraca Life Sciences will start marketing an eighth therapeutic drug monitoring test from Theradiag's Lisa Tracker range in the US.

Under a technology licensing agreement, Miraca will market the test, starting early in November, under the name InformTx.

Theradiag noted that an InformTx report provides clinicians with quantitative test results, historical test result data, and guidance from the most up-to-date peer-reviewed scientific literature. Testing measures the level of a specified drug as well as patient-derived antibodies to the specified drug. Miraca Life Sciences uses laboratory-validated ELISA technology for InformTx therapeutic drug monitoring, and test results are reported within five days.

Oct 16, 2017

Prometheus Laboratories NASH, Crohn's and Inflammatory Bowel Diagnostics

Prometheus Laboratories introduced three new laboratory diagnostic products aimed at nonalcoholic steatohepatitis, or NASH, Crohn’s Disease, and adult inflammatory bowel disease. The FibroSpect NASH test is designed to help clinicians stratify NASH patients by risk based on the severity of their liver fibrosis. The noninvasive serum test was validated with well-characterized and clinically confirmed NASH patients.

The Prometheus Monitr Crohn’s Disease is a serum test for measuring and monitoring serum status in Crohn’s disease patients. Traditionally, Crohn’s Disease has only been diagnosed invasively through colonoscopy and endoscopy.  The Monitor Crohn’s Disease, which can be used as an adjunct to endoscopy or by itself between endoscopies, demonstrated high accuracy and concordance rates with endoscopically visual mucosal disease during clinical validation, Prometheus said.  

The Prometheus Anser UST is a drug-monitoring test for use with adult inflammatory bowel disease patients treated with Stelara, also known as ustekinumab. As a drug-tolerant test, Prometheus Anser UST measures both serum drug concentrations and antidrug antibody levels from a single serum sample to help physicians monitor this biologic therapy and optimize treatment.

Oct 12, 2017

GenePOC Group B Streptococcus Direct Swab

GenePOC launched its Group B Streptococcus Direct Swab molecular test in Europe. The assay is for use on Revogene, the firm's microfluidic real-time PCR instrument, and will help minimize the risk of GBS transmission from mother to baby. It also will help to optimize antibiotic stewardship, said GenePOC, a member of the Debiopharm Group. 

Oct 11, 2017

Hamamatsu NanoZoomer S360

Hamamatsu launched the NanoZoomer S360 high-throughput whole slide imaging scanner. The instrument has a capacity of 360 slides and can deliver fast scanning of 82 slides per hour. It also has an intelligent slide management feature that uses custom barcode labels for personalizing specific scanning parameters to prioritize and scan different tissues with minimal user-scanner interaction. 

Oct 10, 2017

Cyrex Laboratories Array 14 Mucosal Immune Reactivity Screen

Clinical immunology laboratory Cyrex Laboratories launched the Array 14 Mucosal Immune Reactivity Screen, which can assess mucosal immune reactivity in saliva by measuring salivary secretory immunoglobulin A and M. Mucosal production of IgA and IgM antibodies may be an early event in immune reactivity to dietary proteins, bacterial toxins, and tissue antigens, Cyrex said. 

Oct 09, 2017

Fast Track Diagnostics Enteric Fever Kit

Fast Track Diagnostics has launched a kit to detect the pathogens that cause enteric fever, also known as typhoid or paratyphoid fever. The FTlyo Enteric fever kit includes blood collection tubes containing a proprietary Salmonella enrichment broth, ready-to-use multiplex PCR for detection of Salmonella enterica serovar Typhi and Salmonella enterica serovar Paratyphi, and an internal control. The reagents required for the PCR are lyophilized in single-patient sample tubes that can be stored at room temperature, and clinicians need only add extracted nucleic acids to begin the eight-hour detection workflow.

Oct 09, 2017

Sysmex America CyFlow antibodies,

Sysmex America introduced CyFlow antibodies, analyte-specific reagent antibodies for flow cytometry applications. The launch marks Sysmex's entrance into the clinical flow cytometry market, the firm said, adding they can be used on any flow cytometer platform, allowing pathology labs to use the clone with the highest quality for their laboratory-developed tests. 

Oct 06, 2017

Xifin LIS Anywhere NGS Module

Xifin has added a next-generation sequencing model to its LIS Anywhere laboratory information system to support precision medicine. The new module, which will be on display at the College of American Pathologists annual meeting, is intended to help labs build their molecular diagnostics capabilities and improve genomics workflow.

Oct 05, 2017

Sysmex America XN-9100, XN-3100

Sysmex America launched the XN-9100 and XN-3100 hematology automation systems. The new systems combines the unified mechanization of earlier instrument models and has new features to provide labs with greater customization and scalability. For example, both systems integrate the new Sp-50, fifth-generation slidemaker-stainer, enhancing automation, improving both consistency and lab efficiency. 

Oct 05, 2017

Qiagen QuantiFeron-TB Gold Plus

Qiagen is launching the QuantiFeron-TB Gold Plus test in the US. It is the fourth generation of the blood-based test for tuberculosis infection, and was approved by the US Food and Drug Administration in June. The immunoassay detects the release of interferon-gamma as a proxy for latent tuberculosis infection. The newest generation adds CD8 antigens and workflow improvements that allow for more efficient implementation, especially in large-scale TB screening programs. The test will be available in the US starting Oct. 9 and was already available in 75 other countries in Europe, the Middle East, Africa, Asia, and Latin America, Qiagen said. 

Oct 05, 2017

ResearchDx, Menarini Silicon Biosystems DEPArray HER2

ResearchDx and Menarini Silicon Biosystems jointly launched DEPArray HER2, a FISH-based laboratory-developed test performed by PacificDx, a wholly owned subsidiary of ResearchDx. The test leverages cell isolation capabilities of DEPArray NxT technology, enabling pure tumor cell populations to be isolated from heterogeneous tumor/normal tissue samples.

Oct 04, 2017

DiaSorin group C and group G Streptococcus Primer Pairs

DiaSorin Molecular launched the primer pairs, group C and group G Streptococcus for use in laboratory-developed molecular tests. Classified as analyte-specific reagents, they can be used by high-complexity labs to develop their own LDTs. 

Oct 03, 2017

Vector Labs ImmPress Duet Double-Staining Polymer kit

Vector Laboratories launched the ImmPress Duet Double-Staining Polymer kit for immunohistochemistry. It combines highly active horseradish peroxidase and alkaline phosphatase enzyme polymers, conjugated to anti-mouse IgG and anti-rabbit IgG secondary antiboidies. The kit provides low background staining, high signal intensity, and off-target binding elimination, Vector said. 

Oct 03, 2017

CogenDx DxWound

CogenDx has launched its newest test offering, DxWound. The test uses DNA-based technology to provide sensitive detection of an array of microbes, including aerobic and anaerobic bacteria, fungi, and antibiotic resistance genes. Test results equip clinicians to rapidly and accuratley identify pathogens causing infections and choose antibiotics with improved likelihood for success. DxWound utilizes a swab to collect microbial DNA directly from the infection site and leverages a transport buffer that preserves the wound microbiome during specimen transit. Test results are delivered the next business day from specimen receipt at the laboratory. 

Sep 26, 2017

Becton Dickinson CPO Detect Test

BD announced today the launch of its Phoenix CPO detect test, included on the BD Phoenix gram negative panels. It identifies CPOS and provides the Ambler classification of the enzyme produced. According to the company, the test can detect CPOs in under 36 hours. The CPO test will enable laboratories to offer a comprehensive antimicrobial susceptibility test profile while performing laboratory processs efficiency. 

Sep 26, 2017

DiaSorin Molecular Pneumocystis Jirovecii Primer Pair

DiaSorin Molecular has introduced a Pneumocystis jirovecii primer pair for use in laboratory-developed molecular tests. This analyte-specific reagent can be used for the amplification and detection of the P. jirovecii mtLSU gene with a CFR610- and BHQ-2-labeled probe and forward and reverse primers. This is DiaSorin's first fungal infectious disease target, and the new primer pair adds to the company's menu of more than 60 molecular reagents for the detection of bacterial and viral targets, and human genetic mutations.

Sep 25, 2017

Interpace Diagnostics MVPdX Lung Cancer Test

Interpace Diagnostics has launched a new lung cancer test, MVPdX, that  compares the mutational fingerprint of two or more sites of lung cancer to differentiate new primary lung tumors from recurrences or metastases. The assay is based on an analysis of loss of heterozygosity via a panel of microsatellite markers in proximity to 16 tumor suppressor genes.

Sep 22, 2017

ProteinSimple 32x4 Simple Plex cartridge

Bio-Techne brand ProteinSimple launched its 32x4 Simple Plex cartridge for the Ella immunoassay platform. The cartridge simultaneously measures up to 32 different samples, such as serum, plasma, and cell culture supernatants, against four different analytes of interest. It doubles the current sample throughput while maintaining a total immunoassay time of 85 minutes, ProteinSimple said, adding it comes preloaded with analyte-specific capture and detection antibodies, and detection reagents. 

Sep 20, 2017

Blueprint Genetics Whole Exome Sequencing

Blueprint Genetics is now offering whole-exome sequencing to customers in the US. The assay has a minimum mean coverage of 100-fold. On average, 98.9 percent of gene-coding regions, captured with Agilent SureSelect V6, are covered at least 15-fold. The company confirms all clinically relevant variants by Sanger sequencing and its interpretation team includes clinical experts. Turnaround time for the assay, which comes in different versions, is six to nine weeks.

Sep 19, 2017

ARUP Laboratories/IDbyDNA Explify Respiratory

ARUP Laboratories and IDbyDNA have launched Explify Respiratory, a next-generation sequencing-based test for respiratory infections. Explify Respiratory detects more than 200 common and rare bacterial, fungal, and viral respiratory pathogens with a single test. It is powered by IDbyDNA's Taxonomer software, a DNA search engine that can rapidly identify any organism by its genetic material. The test is the first in a line of tests that ARUP Labs and IDbyDNA plan to launch as part of a previously announced strategic partnership to develop and commercialize infectious disease testing using metagenomics.

Sep 14, 2017

Qnostics ME Evaluation Panel

Qnostics launched the ME Evaluation Panel for meningitis/encephalitis evaluation. It consists of 14 controls for the qualitative detection of bacterial, viral, and fungal targets, including Neisseria meningitidis, Haemophilus influenzae, Escherichia coli K1, and others. The panel can be used to independently monitor each target and all phases of the testing process, Qnostics said, adding it was designed with known performance on the BioFire FilmArray platform. 

Sep 13, 2017

Phosphorous Ophthalmology, Drug Response Test

Computational genomics firm Phosphorus launched a test for inherited conditions associated with vision loss and blindness, and a pharmacogenomic test to assess the efficacy of various drugs based on their genetic makeup. The ophthalmology genetic test covers retinal disorders, cataracts, glaucoma, and corneal dystrophy. The drug response test covers cardiology, psychiatry, oncology, pain management, neurology, immunology. gastroenterology, repiratory, infectious disease, and others. 

Sep 13, 2017

Variantyx Unity

Variantyx launched the Variantyx Unity test, a genomic diagnostic test that identifies small sequence changes, structural variants, trinucleotide repeat expansions, and mitochondrial variants from a single DNA sample. The test uses whole-genome seuqncing data analyzed by the firm's Genomic Intelligence platform, and eliminates the need for multiple sequential tests, the firm said. 

Sep 12, 2017

DiaSorin Molecular Simplexa C. difficile Direct Assay

DiaSorin Molecular has launched the Simplexa C. difficile Direct Assay in the US. The assay aids in the diagnosis of infection by detecting the C. difficile toxin B gene in liquid or unformed stool samples, and had been available outside the US since November. The US Food and Drug Administration cleared the test in February

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