Oncohematology

Bioclarma’s Oncohematology Line products are in vitro diagnostic medical devices designed to detect markers associated with the most common hematological diseases. These devices support physicians in the diagnosis and monitoring of patients affected by chronic myeloid leukemia (CML), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and acute promyelocytic leukemia (APL). The "SensiQuant" and "SensiQuant Direct" devices provide an in vitro diagnostic system for the detection and quantitative measurement of translocations: t(9;22), BCR-ABL (Philadelphia chromosome), variants P210, P190, P230, e1a3, b3a3/b2a3, e6a2/e6a3 t(15;17), PML/RARa variants BCR1, BCR2, and BCR3 t(16;16), CBFB/MYH11 variants INV-16A, INV-16D, and INV-16E t(8;21), AML1/ETO t(12;21), TEL/AML1 in total RNA samples extracted from peripheral blood, bone marrow, and leukocyte suspensions using "One-Step" technology: reverse transcription to cDNA followed by real-time PCR amplification with a TaqMan probe in a single tube. To further support diagnostic research, we also offer our "Reference" line. The "Reference" kits are systems designed to calibrate diagnostic devices for the quantification of the molecular markers mentioned above. These kits are used to: Evaluate the performance of the quantitative test for the transcript derived from the targeted translocation, normalized against the ABL gene transcript. Calculate the Conversion Factor (CF) required to express the final quantification result of the BCR/ABL P210 transcript on the International Scale (IS). Assess the performance of quantitative tests for transcripts from targeted translocations, normalized to the ABL gene transcript.