Ortho Clinical Diagnostics Alanine Aminotransferase Technology

Dec 19, 2017

Ortho Clinical Diagnostics announced the launch of Vitros ALTV Slides, a method that uses dry slide technology for the measurement of alanine aminotransferase (ALT), a key liver function enzyme found in serum and plasma. 

ALT is used in the diagnosis and treatment of heart diseases and certain liver diseases, such as viral hepatitis and cirrhosis. Due to its distribution primarily in the liver, elevated ALT levels are highly suggestive of liver damage, and ALT measurements are particularly useful in the diagnosis and management of liver disease, Ortho said.

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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.

Nov 07, 2018

QuestDirect

Quest Diagnostics announced the launch of QuestDirect, a consumer-initiated testing service that empowers patients to order health and wellness lab testing from home. The service, available in 48 states, offers 35 test packages for general health, men's and women's health, digestive health, heart health, infectious disease, and sexually transmitted disease testing. Consumers can order by visiting the QuestDirect website and choosing their own lab tests. Independent physicians will provide oversight and, if appropriate, order the testing. Consumers can make appointments online to visit a Quest patient service center. Results are typically available within a week, and can be accessed through MyQuest, where they can be shared with the consumer's doctor or family members through a new "My Circle" feature.

Nov 02, 2018

Vela Diagnostics Great Basin Platform

Vela Diagnostics has commercialy launched the Great Basin infectious disease diagnostic system in Europe and the US. In preparation for the launch, Vela has relisted the products with the US and Food and Drug Administration and CE-IVD under its name. Initial site placements are evaluating the firm's Stool Bacterial Pathogens Panel. The evaluation will then be followed by Great Basin's five additional assays, including the Staph ID/R Blood Culture panel, Group B Strep Test, Shiga Toxin Direct Test, Bordetella Direct Test, and the Toxigenic C. diff test. All the assays use the Great Basin Analyzer, which is designed to perform automated sample extraction and chip-based detection in a fully enclosed cartridge with integrated data analysis.

Nov 01, 2018

Pixel by LabCorp

Laboratory Corporation of America has launched Pixel by LabCorp, an at-home blood sample collection kit intended to create a differentiated consumer experience. Consumers can purchase test packages at Pixel.LabCorp.com, and typically will receive a sample self-collection kit within two to three days. The test packages include a physician review and order, which is required for all Pixel by LabCorp testing and is seamlessly integrated into the overall digital experience. The consumer collects the sample and returns it in the postage paid, pre-addressed kit box to LabCorp's CAP-accredited and CLIA-certified lab. Within two to three days of receiving the sample, LabCorp posts and easy-to-read test report to the consumer's online account. Consumers can purchase Pixel by LabCorp test packages for wellness, heart health, diabetes, and colorectal cancer. Additional test offerings are planned in the near future. Pixel by LabCorp is available to consumers 18 or older in 45 states. It is currently not offered in Maryland, Massachusetts, New Jersey, New York, and Rhode Island.

Nov 01, 2018

Veritas Genetics myGenome Premium, myGenome Diagnostic

Veritas Genetics announced it is now offering myGenome Premium and myGenome Diagnostic services, in addition to its $999 myGenome Standard service. The premium service is priced at $1,499 (or $500 for customers of the standard service) and is for those want a more indepth analysis of their carriers status, cancer risks, and cardiovascular risks. Within the premium service, customers will receive information on more than 400 genes associated with around 20 actionable conditions and on 125 genes linked to more than 200 carrier conditions. 

The $2,999 myGenome Diagnostic service ($1,999 for customers of the standard service) is for those with a personal or family history of a genetic condition, and providers interpretation of all genes known to be associated with the disease. This service is availalbe for adults and pediatric patients, and customers will also receive reports included in the standard service.

Within myGenome Standard, Veritas is also adding a new section that inlcudes "lower-impact genetic findings" associated with 15 commone diseases, for which individuals may be able to lower their risks via lifestyle changes.

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Oct 31, 2018

Agilent Technologies Agilent OnePGT

Agilent Technologies has launched Agilent OnePGT, a genome-wide, next-generation sequencing solution for preimplantation genetic testing. OnePGT allows parallel detection of multiple monogenic disorders, translocations, and aneuploidies from a single biopsy, going from biopsy to a single comprehensive report in a matter of days, Agilent said. The test is run on the company's Alissa platform, allowing for automatic calling of genetic abnormalities with built-in quality control metrics and an audit trail. This solution provides fertility specialists more comprehensive PGT data in order to help them identify the most viable embryos for transfer.

Oct 31, 2018

Uromonitor Bladder Cancer Recurrence Test

Uromonitor has launched its genetic test for detecting the recurrence of bladder cancer. Also called Uromonitor, the urine-based test detects trace amounts of FGFR3 and Tert promoter mutations, which are associated with early stages of bladder cancer. Portugal's Institute of Molecular Pathology and Immunology of the University of Porto, and the Institute for Research and Innovation in Health developed the test, which is CE marked. 

Oct 30, 2018

Vela Diagnostics Sentosa SQ HCV Genotyping Assay

Vela Diagnostics has launched a new version of its Sentosa SQ HCV Genotyping Assay with improved reporting and data-interpretation features. The test uses next-generation sequencing to detect HCV genotypes 1, 2, 3, 4, 5, and 6, and subtypes 1a and 1b, and to report HCV variants in clinically relevant regions of NS3, NS5A and NS5B genes to allow drug-resistance assessment. This assay offers an integrated solution from sample to result in approximately two days with hands-on time of less than 2.5 hours.

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Cofactor Genomics ImmunoPrism Immune Profiling Kit

Cofactor Genomics launched the RNA-based ImmunoPrism Immune Profiling kit for deriving the immune composition of tumor samples, which it said has become a valuable indicator of response to immunotherapies and cancer drugs in development. The kit provides labs access to the same kit Cofactor uses to prep, sequence, and analyze against its database of machine-learing optimized immune reference expression models. 

Oct 29, 2018

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Sirona Dx has announced the launch of its Oncocyst PD-L1 assay. The tool uses IncellDx technology to detect and quantify abnormal bladder cells and immune cells from urine cytology specimens that express the immune-oncology marker PD-L1 using multi-parameter flow cytometry and bioinformatics. Sirona's algorithm uses aneuploidy/DNA content in cells from the bladder. Researchers can perform the high-throughput, non-subjective assay in less than three hours, the firm said.

Oct 26, 2018

CooperSurgical PGTai Technology Platform, ERPeak Endometrial Receptivity Test

CooperSurgical Fertility and Genomic Solutions has launched the CooperGenomics PGTai technology platform and the ERPeak endometrial receptivity test. Both will be available in North American from November 1 and internationally starting in January 2019.

The PGTai platform uses artificial intelligence and machine learning to improve the analysis, interpretation, and reporting of preimplantation genetic testing for aneuploidies (PGT-A). It is built on data from more than 1,000 biopsies that led to healthy babies. To validate the platform, the company analyzed sequencing data from more than 10,000 embryos and 5 million data points.

The ERPeak endometrial receptivity test detects the receptivity status of a woman's endometrium accurately and reliably. It measures the expression of several relevant hormone-regulated genes.

Oct 24, 2018

Cytek Biosciences Northern Lights Flow Cytometer

Cytek Biosciences has launched its Northern Lights flow cytometry system. The platform, the company said, makes three lasers and more than 24 colors possible at an affordable price. Cytek also launched two accessories to its flow cytometry solutions: the 561 nm laser, and a new plate reader. THe laser, which is availalbe for Cytek Aurora models only, adds 10 more fluorescence detection channels, it said, while the new plate reader offers walk-away capabilities and support 96-well plates, three throughput modes, and user customizable modes.

Oct 24, 2018

Lucence Diagnostics LiquidHallMark

Lucence Diagnostics launched the LiquidHallMark blood test for detecting multiple cancer-related mutations and viral targets for clinical use in Asia. Physicians can use the test to select targeted therapies and to monitor treatment response. The liquid biopsy panel identifies clinically relevant genomic alterations including somatic mutations, microsatellite instability, and viral DNA from ctDNA in blood. It was developed for cancers that are particularly prevalent in Asia, such as breast, colon, lung, and nasopharyngeal cancers. The test is based on Lucence's proprietary technology called AmpliMark that has sensitivity and specificity of up to 99.9 percent, the company said.