GenomeDx Decipher Bladder Cancer Classifier

May 10, 2017

GenomeDx Biosciences launched its Decipher Bladder Cancer Classifier, a clinical assay for subtyping muscle invasive bladder cancer. The commercial launch follows the publication of a study supporting the assay's development and validation. The test is for use by physicians to stratify patients into more accurate risk groups than can be done with traditional diagnostic diagnostic tools. It also is for identifying those patients who are most likely to benefit from additional treatment. 

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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 meothodsto help clinical laboratories deliver accurate results during cold and flue season. The panels include features suc has 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.

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.

Oct 31, 2018

NeuMoDx 288 and NeuMoDx 96 Molecular Systems

NeuMoDx Molecular has launched the NeuMoDx 288 Molecular System and the NeuMoDx 96 Molecular System in the US. The 288 system loads up to 288 patient samples and has been cleared by the US Food and Drug Administration, while the 96-sample instrument is registered with the FDA for lab-developed testing use. Both instruments are PCR-based and enable continuous, random-access, sample-to-results workflows for on-demand, high-throughput sample processing with an operator walkaway window of up to eight hours. The systems use the firm's proprietary NeuDry reagents which require no refrigeration and have an on-board stability of up to 60 days and room temperature shelf life of more than one year. The instrument can run NeuMoDx's growing menu of infectious disease and sexually transmitted infections assays, as well as LDTs using the company's general-purpose reagents and consumables.
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.