DiAGSure® PML-RARA fusion Detection RT PCR Kit

Catalog No.: GDQ2381-50R, GDQ2381-100R
Intent to use:
The DiAGSure® PML-RARA Fusion Detection Kit is a real-time PCR assay developed for the qualitative detection of the PML-RARA fusion gene, which results from the t(15;17)(q24;q21) translocation—a genetic hallmark of acute promyelocytic leukemia (APL). This translocation fuses the PML gene on chromosome 15 with the RARA gene on chromosome 17 and is present in approximately 99% of APL cases. While diagnosis can be supported by morphology, detection of this fusion is considered definitive in clinical and research settings. Depending on the breakpoint within the PML gene, different transcript variants are formed: long (bcr1/intron 6, ~50–55%), short (bcr3/intron 3, ~30–40%), and variant (bcr2/exon 6, ~5–10%). The assay enables early identification of these subtypes, which is critical for prompt initiation of targeted therapies such as ATRA and arsenic trioxide, improving prognosis and clinical outcomes.

Key Specifications:
 Qualitative detection of the PML-RARA fusion gene, caused by the t(15;17)(q24;q21) translocation—diagnostic of acute promyelocytic leukemia (APL).
 Identifies transcript subtypes: long (bcr1/intron 6), short (bcr3/intron 3), and variant (bcr2/exon 6), representing ~50–55%, ~30–40%, and ~5–10% of APL cases respectively.
 Covers over 99% of APL cases, where PML-RARA fusion is a defining molecular marker.
 Supports rapid clinical decision-making for initiation of ATRA and arsenic trioxide therapy.
 High sensitivity and specificity enable detection from clinical RNA samples, even at low transcript levels.

 Sample types:
Whole Blood, Biopsy tissue, FNAC.

Product information: