CEPHEID Xpert BCR-ABL Ultra

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

SPD SCIENTIFIC PTE LTD

Class:

Class C IVD

Manufactured by:

Cepheid

Therapeutic area:

Pathology

Therapeutic indications:

The Xpert BCR-ABL Ultra test is an in vitro diagnostic test for the quantitation of BCR-ABL1 and ABL1 mRNA transcripts in peripheral blood specimens of diagnosed t(9;22) positive Chronic Myeloid Leukemia (CML) patients expressing BCRABLl fusion transcripts type e13a2 and/or e14a2. The test utilizes automated, quantitative, real-time reverse transcription polymerase chain reaction (RT-qPCR). The test is intended to measure BCR-ABL1 to ABL1 percent ratios on the International Scale (IS), and also expressed as a log molecular reduction (MR value) from a baseline of 100% (IS), in t(9;22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs). The test does not differentiate between e13a2/b2a2 or e14a2/b3a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t(9;22). This test is not intended for the diagnosis of CML.The test is intended for use only on the Cepheid GeneXpert® Dx System and the GeneXpert Infinity System.

Product summary:

Models: Xpert BCR-ABL Ultra - GXBCRABL-10

Authorization date:

2022-11-09