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regulatory approval

Qiagen's test detects the most frequently occurring somatic mutations in EGFR in less than four hours using real-time PCR on the Rotor-Gene Q platform.

QuantiFeron-TB Gold Plus features antigens that measure the cell-mediated immune response to TB infection from both CD4 and CD8 T cells.

The tests are designed to detect genetic variations including SNPs, insertion-deletions, copy number variations, and variations in segmental duplications.

Foundation Medicine's assay detects genomic alterations in 324 cancer genes and serves as a companion diagnostic for patients with certain types of tumors.

The test is now approved as a CDx for advanced ovarian cancer patients considering Lynparza as a first-line maintenance treatment.

The firm’s test for detecting flu and differentiating between subtypes A and B is being launched in Europe, Asia, and South America.

The GenoCTC isolation kit isolates epithelial cell adhesion molecule-positive cells from liquid biopsies and was cleared as a reagent for an IVD device.

With the approval Sera is permitted to provide lab testing services ordered by a medical professional for use by pregnant women in all US states.

The test is a lateral flow, in vitro qualitative immunoassay that detects human antibodies to HIV virus type 1 and type 2 in whole blood.

The test covers 27 genes in which variants are known to contribute to the effectiveness or safety of more than 360 medications for 30 conditions.

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