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Jan 04, 2021

Verichem Laboratories Clinical Reference Materials

Verichem Laboratories announced the availability of ready-to-use, liquid-stable clinical reference materials for the calibration and calibration verification of clinical testing systems. The products support overall quality control and CLIA compliance and are used to determine a clinical system’s bias to a true or known value. Further, the reference materials are used for the independent determination of test method accuracy, sensitivity, linearity, and reportable range. They address the needs of a variety of medical laboratory professionals, including those involved in routine laboratory testing, clinical research applications, and the development and manufacturing of in-vitro diagnostic products.

Jan 04, 2021

Bruker MBT Sepsityper Kit US IVD

Bruker has launched its US Food and Drug Administration-cleared MBT Sepsityper Kit US IVD for rapid microbial identification of more than 425 microorganisms from positive blood cultures on the company's MALDI Biotyper CA System.

The MBT Sepsityper Kit US IVD enables rapid, specific detection of many cases of bacteremia-induced sepsis to assist infectious disease specialists. The kit performs identification directly from positive blood cultures with a time-to-result of less than 30 minutes.

Dec 17, 2020

Autogen NeXTRACT 48

AutoGen has launched the NeXTRACT 48 platform for the rapid extraction of viral DNA and/or RNA from a variety of samples including viral transport media, universal viral transport, and sputum. NeXTRACT 48 is compatible with most COVID-19 real-time PCRs diagnostic kits, is compact and easily fits into a BSL2 environment, and can process 48 samples in 20 minutes or 800 samples or more per day, AutoGen said. The platform is ideal for labs looking to supplement COVID-19 viral RNA extractions or to add a back-up platform with a low capital investment and operating cost, with consumables costing less than $5 per sample, the Holliston, Massachusetts-based company said.

Dec 17, 2020

Personalis SHERPA, NEOPS

Personalis has launched its Systemic HLA Epitope Ranking Pan Algorithm (SHERPA) machine learning-based tool for identifying and characterizing cancer neoantigens, as well as its Neoantigen Presentation Score (NEOPS) for predicting  cancer immunotherapy response.

SHERPA assesses the potential MHC-binding affinity and stability of identified peptides, and incorporates features linked to antigen processing machinery and RNA abundance to produce a presentation rank for each detected peptide. The rank determines the relative likelihood of a given neoantigen being presented and undergoing immunosurveillance. Integrated into the firm's NeXT platform, the tool allows for the development of new neoantigen-based diagnostic biomarkers, such as its NEOPS biomarker, and neoantigen-targeting personalized cancer therapies.

Personalis' NEOPS combines the tumor genomic and immune-related analytics of the firm's NeXT platform to create a composite biomarker, that the firm believes can be more effective in predicting immunotherapy responses than other biomarkers.

NEOPS and SHERPA are the latest updates to the comprehensive suite of advanced analytical engines of the Personalis NeXT Platform for biopharmaceutical customers, the company said.

Dec 17, 2020

Invitae Exome Reanalysis

Invitae has begun offering customers of its exome sequencing service routine case-level reanalysis of their results every six months for a minimum of three years. This will ensure that patients' results are up to date based on the latest variant classification research. The reanalysis will be conducted by the company's team of genetics experts, who will utilize an artificial intelligence-powered diagnosis engine that Invitae garnered with the acqusition of Belgian firm Diploid, and a gene-phenotype database.

Dec 11, 2020

ATCC SARS-CoV-2 External Control Kit

ATCC has introduced a SARS-CoV-2 External Control Kit for clinical laboratories and test manufacturers. The new kit enables clinical laboratories to meet federal regulations stipulating that they assess the performance of their testing applications. The kit comprises a universal, full-process positive control (a heat-inactivated virus) and negative control (human cell line) that allow clinocal labs to verify and assess the quality of their molecular diagnostic assays.

Dec 08, 2020

LGC Maine Standards: Validate PTH

LGC Maine Standards has launched the Validate PTH for labs running the Roche Cobas platform and in need of verifying the linearity and calibration of their systems. Validate PTH includes the analyte parathyroid hormone and is formulated in a human serum matrix using the CLSI EP06-A "equal delta" sample preparation method. It provides five distinct concentrations across the claimed range of Roche's Cobas instrument. LGC Maine Standards said that in combination with calcium, magnesium, and phosphorous in Validate GCI and vitamin D in Validate VIT D, labs can challenge the reportable range of Roche Cobas bone-related assays. While supporting daily quality control, it can help fulfill quality control requirement, including analytical measurement range and reportable range for linearity and calibration verification under CLIA "88, CAP, COLA, JCAHO, JCI, and ISO 15189.  

Dec 07, 2020

Verichem Laboratories Tru-Zero Bilirubin Standard

Verichem Laboratories has made its Tru-Zero Bilirubin Standard available as part of the firm's total and direct standard materials. The assays have a verified concentration level of 0.0 mg/dL and is for verifying the calibration of total and direct bilirubin assays with various chemistry testing systems, including systems from Abbott Diagnostics, Advanced Instruments, Beckman Coulter, Roche Diangostics, and Siemens Healthineers, Verichem said.

Tru-Zero Bilirubin Standard incorporates a proprietary stabilization process, eliminating the need for azide, glycol, or surfactants, the company said, adding it features a refrigerated open-vial product stability claim of five days, and a shelf-life of 14 months when stored at 2 to 8 degrees Celsius.

Dec 03, 2020

Meridian Bioscience Air-Dryable RT-qPCR Mix

Meridian has launched its Air-Dryable RT-qPCR mix, a specialized master mix designed for air drying instead of lyophilization. The ready-to-use mix has ambient temperature stability and removes the need for cold chain shipping and storage, the company said. Its one-tube format chemistry contains all the reagents necessary for RT-qPCR, including magnesium, dNTP, and reverse transcriptase.

The mix is designed to simplify development, manufacturing, and storage of molecular tests, along with delivering fast detection of RNA targets, making the mix ideal for COVID-19 testing, the firm said. Meridian added that the mix has high performance in singleplex and multiplex reactions after rehydration.

Nov 17, 2020

GeneMatters Automation for Pioneer Telegenetics Platform and RISE Patient Engagement Tools

GeneMatters has added automation features to its Pioneer Telegenetics Platform and has launched RISE Patient Engagement Tools to support patients undergoing genetic testing and counseling.

The Pioneer Telegenetics Platform, available since 2017, is designed to integrate telehealth genetic counseling service delivery and patient management. The platform now includes several automation features designed to reduce administrative burden, provide real-time communication, and allow GeneMatters to quickly deploy custom workflows to meet partner needs.

The RISE (Reach, Inform, Support, and Educate) Patient Engagement Tools specifically support patients and can be used independently or as a complement to Pioneer, and will include modules for genetic care such as scheduling, patient triage, patient education, and results delivery.

Nov 11, 2020

NeoGenomics Mobile Phlebotomy Services

NeoGenomics has launched a mobile phlebotomy service for its blood-based tests, including the InVisionFirst-Lung assay and the NeoLab liquid biopsy suite of tests. The firm will offer in-home mobile phlebotomy services through ExamOne and Metro Health Staffing. NeoGenomics said it will arrange for the blood sample collection at the patient's desired location and cover the expense of the service. 

Nov 10, 2020

Galaxy Diagnostics Nanotrap Urine Test for Lyme Borreliosis

Galaxy Diagnostics has launched the Nanotrap Urine Test for Lyme Borreliosis. According to the Research Triangle Park, North Carolina-based firm, the antigen test provides the most sensitive direct detection of Borrelia burgdorferi at all stages of the disease. It leverages Nanotrap technology developed by Ceres Nanosciences to capture and concentrate low abundance outer surface protein A in urine samples confirmed by Western blot.

Nov 10, 2020

NIPD Genetics: Amfira PGT

NIPD Genetics has launched Amfira PGT, a preimplantation genetic test to detect genetic abnormalities in embryos. The test consists of two panels, the PGT-A panel for aneuploidies for individuals or couples undergoing in vitro fertilization, and the PGT-SR panel for structural rearrangements for couples diagnosed with a structural rearrangement. Both panels can detect selected male polyploidies, as well as deletions and duplications larger than 10 megabases. The turnaround time is five to seven days from sample receipt.

Nov 06, 2020

Bio-Rad: StarBright Dyes

Bio-Rad has launched three new dyes for flow cytometry in its StarBright line. StarBright Blue 700, StarBright Violet 440, and StarBright Violet 610 consist of fluorescent nanoparticles conjugated to flow antibodies. The dyes offer narrow excitation and emission profiles for improved resolution in flow cytometry experiments. They are also resistant to photobleaching and highly stable, with minimal lot-to-lot variation, according to Bio-Rad, which enables researchers to achieve consistent and reproducible staining. The dyes work with all common staining buffers for easy integration into multicolor panels and the chemistry is designed to ensure no loss of signal in fixation.

Nov 05, 2020

Enzo Biochem Microplate Reader

Enzo Biochem launched a small portable microplate reader for use with the company's immunoassays and molecular diagnostics. Enzo provides more than 17,000 ELISA assays and kits. The design and technology of the new compact microplate reader makes it possible to deliver precise and accurate results, the firm said.

The Enzo portable reader enables lab work to be executed outside of traditional research facilities, giving researchers and lab professionals a dedicated, personal device to fit their space and needs with convenience and accessibility. The handheld instrument is about one-tenth the size of the average benchtop plate reader, allowing it to fit into any laboratory setting and saving bench space, while providing flexibility and portability that can be extended to point-of-care facilities to allow physicians to provide molecular testing.

In the future, the company said it anticipates launching isothermal testing on this platform, enabling constant temperature and eliminating the need for a thermal cycler.

Nov 02, 2020

Castle Biosciences DecisionDx DiffDx-Melanoma

Castle Biosciences has launched DecisionDx DiffDx-Melanoma, a gene expression profile test for use in patients with suspicious pigmented lesions. The test is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions, and classifies these lesions as either benign (gene expression profile suggestive of benign neoplasm), intermediate-risk (gene expression profile cannot exclude malignancy), or malignant (gene expression profile suggestive of melanoma).

The intent-to-treat analysis of the DiffDx-Melanoma validation study showed that the test accurately diagnosed malignant and benign cases at a rate of 96.6 percent, with 99.1 percent sensitivity, 94.3 percent specificity, 93.6 percent positive predictive value, and 99.2 percent negative predictive value, the company said. An intermediate-risk result was identified in 3.6 percent of the cases.

Oct 27, 2020

Enzo Biochem GoTestMeNow

Enzo Biochem has launched GoTestMeNow, an online platform that enables consumers to directly order physician-authorized laboratory tests. GoTestMeNow can be used to access necessary medical tests without the need for a doctor's office visit, the company said. Specimen collection and testing is accomplished through a network of patient service centers in the New York/New Jersey metro area and consumers can get their results through a secure online portal. The platform will also facilitate any issues related to payment, including insurance coverage.

The GoTestMeNow platform will initially support access to COVID-19 molecular and antibody testing, and will then be expanded to offer access to a broad range of additional tests in the near future, Enzo added.

Oct 23, 2020

Fabric Genomics Fabric GEM Algorithm for Genetic Disease Diagnosis

Fabric Genomics has launched Fabric GEM, an algorithm designed to identify the likely genetic cause of rare diseases from next-generation sequencing data. Fabric GEM, the latest product in the Fabric Enterprise software suite, uses artificial intelligence to analyze sequencing data (including complex structural variants) and patient clinical information in order to perform probabilistic disease matching and speed genetic diagnoses. The algorithm was developed in collaboration with Mark Yandell of the University of Utah and Stephen Kingsmore of Rady Children's Institute for Genomic Medicine, Fabric said.

Oct 22, 2020

Bionano Genomics Access v1.6, Solve v3.6

Bionano Genomics has updated its suite of data analysis and visualization software tools for its Saphyr genome mapping platform. The new version of Bionano Access is designed to simplify and accelerate every step in the data-analysis workflow, enabling clinical labs to develop tests on the Saphyr more easily. It builds on the Bionano EnFocus FSHD Analysis tools for the automated analysis of variants in a form of muscular dystrophy to allow for similar automated variant analysis for EnFocus panels for other genetic conditions. These include autism spectrum disorder, developmental delay, and repeat expansion disorders, as well as hematologic malignancies and solid tumors. The new version also enables Bionano EnFocus FSHD data to be analyzed on a PC rather than in the cloud or on a compute cluster. In addition, it reduces the time and increases capacity for analyses run on Bionano's cloud-based platform.

Oct 20, 2020

Genome Diagnostics NGSgo-MX11-3 Multiplexing for HLA Typing

Genome Diagnostics has launched NGSgo-MX11-3, its latest addition to a series of singleplex and multiplex amplification strategies for HLA typing by NGS. NGSgo-MX11-3 consists of amplification primers for eleven HLA genes — HLA-A, -B, -C, -DRB1, -DQB1 and -DPB1, DRB3/4/5, DQA1, and DPA-1 — in three mixes per sample. The three-tube design results in low noise levels and well-balanced alleles, making the data quality of the 11-loci multiplex similar to a singleplex strategy, Genome Diagnostics said. NGSgo-MX11-3 is available on a research-use-only basis. The firm anticipates that it will become available as a CE-marked IVD.

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