Fastplex™ BCR-ABL (p210) %IS digital PCR Kit - FDA 510(K) cleared

The Fastplex™ BCR-ABL (p210) % IS digital PCR Kit is an in vitro nucleic acid amplification test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t(9;22) positive Chronic Myeloid Leukemia (CML) patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The Fastplex™ BCR-ABL (p210) % IS digital PCR Kit is a reverse transcription-quantitative PCR performed on the RainSure DropMDx digital PCR System and is intended to measure BCR-ABL1 to ABL1, expressed as a log molecular reduction (MR value) from a baseline of 100% on the International Scale, in t(9;22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs).

The Fastplex™ BCR-ABL (p210) % IS digital PCR Kit is intended for use only on the RainSure DropMDx digital PCR System.

The test does not differentiate between e13a2 or e14a2 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.

Limitations and Disclaimers

• The test does not differentiate between e13a2 or e14a2 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 assay is not indicated for determining discontinuation from TKI treatment nor for monitoring after discontinuation.
• Test results should be interpreted in conjunction with the patient's clinical history, physical examination, and other laboratory findings.

Product not currently available for sale in the United States. For international distribution only.

510(K) number: K252243