LabCorp ADAMTS13 Test

Jul 19, 2017

Laboratory Corporation of America began offering the ADAMTS13 test for a rare life-threatening blood-clotting disorder. The test distinguishes diseases characterized by acute thrombotic microangiopathy (TMA), a relatively rare syndrome in which small blood vessels develop blood clots. The test can provide faster and more accurate results, compared to other tests, to rule in or out the diagnosis of thrombotic thrombocytopenia purpura, a condition that can cuase TMA, and to support decisions whether to start patients on certain therapies, LabCorp said. The test is run on liquid chromatography-tandem mass spectrometry technology.

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Oct 15, 2018

Roche NGS Avenio Tumor Tissue Analysis Kits

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Oct 10, 2018

Waters RenataDx Screening System

Waters has launched the RenataDx Screening System, which uses flow-injection tandem mass spectrometry for rapid, high-throughput analysis of extracted dried blood spots and other human biological matrices. The system can run on any FIA-MS/MS laboratory-developed test or ready-to-use reagent kit, Waters said, adding it incorporates the combination of the company's Xevo TQD IVD mass spectrometer, the Acquity UPLC I-Class IVD Binary Solvent Manager, and the 3777C IVD Sample Manager. It is manufactured as a US Food and Drug Administration Class I medical device and is CE marked.

Oct 09, 2018

MDNA Life Sciences Mitomic Prostate Test

MDNA Life Sciences has announced the UK release for its PCR-based Mitomic Prostate Test (MPT). The MPT is a liquid biopsy assay optimized for the early detection of prostate cancer in advance of biopsy. The firm designed the MPT for testing men with clinical suspicion of prostate cancer to determine their likelihood of clinically significant cancer that may benefit from rapid intervention. The test will run on MDNA's CE-IVD kit, which contains the needed reagents to process up to 21 patient samples at a time.

Oct 09, 2018

Singulex Clarity C. diff toxin A/B assay

Singlulex launched the Singulex Clarity C. diff toxin A/B assay, a rapid, high-sensitivity, high-precision, one-step solution that the company said matches the sensitivity and specificity of cell cytotoxicity neutralization assays. The test leverages Singulex's Single Molecule Counting technology to detect C. difficile toxins at an analytical sensitivity that detects 100 times lower concentrations than current immunoassays, the firm said, adding results can be obtained in less than 35 minutes. 

Oct 09, 2018

Vermillion OVA1(R)+

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Oct 08, 2018

Ortho Clinical Diagnostics Kapa Free Light Chain, Lambda Free Light Chain, Methotrexate Assays

Ortho Clinical Diagnostics has launched its Kapa Free Light Chain and Lambda Free Light Chain assays in collaboration with Diazyme Laboratories. The assays are being made available through its MicroTip Partnership Assay program, which was established to validate third-party assays for use on Ortho Clinical's platforms. The company also said that it will offer the methotrexate assay in collaboration with Ark Diagnostics and Sekisui Diagnostics. 

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Oct 04, 2018

Precipio HemeScreen

Precipio this week commercially launched HemeScreen, a test for mutations in hematologic cancers. The test measures for mutations in the CALR, JAK2, JAK2 exon 12, and MPL genes, which are critically important to developing the clinical roadmap for the patient, Precipio said. The company will offer the assay through its CLIA laboratory in New Haven, Connecticut, and will also offer a set of RUO reagents to other reference labs to perform the test in their CLIA laboratories.

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Seq2Know Celiac Disease Testing

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Beckman Coulter Kaluza C Flow Cytometry Analysis Software

Beckman Coulter has launched the Kaluza C Flow Cytometry Analysis Software for the clinical lab. The company said the FDA-listed and CE-marked data analysis system streamlines clinical QC reporting and addresses standardization issues in flow cytometry. 

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MNG Xpress Exome

MNG Laboratories has launched the MNG Xpress Exome, a diagnostic exome sequencing test to identify mutations in Mendelian disorders. The test, which has a turnaround time of 10 to 14 days, costs $4,895 for a trio and $3,295 for proband-only testing.

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