The NeoLAB™ BTK Inhibitor Acquired Resistance Panel is a blood test performed by modified properietary bi-directional sequencing of the BTK and PLC-gamma-2 genes using cell-free circulating tumor DNA (ctDNA). This method allows detection of mutations with sensitivity of 10(-4). Analysis includes the BTK mutation C481S and surrounding regions corresponding to amino acids C464 to M509 and the following PLC-gamma-2 mutations and surrounding regions: R665W (W646 to S679), S707 (A681 to M743), and L845F (I839 to V860).
The NeoLAB BTK Acquired Resistance Panel detects mutations in Bruton tyrosine kinase (BTK) and PLC-gamma-2, which are two key driver genes in B-cell receptor pathway and play major role in lymphoproliferative neoplasms, especially in chronic lymphocytic leukemia (CLL), mantle cell lymphoma and diffuse large B-cell lymphoma (DLBL). Treating CLL with BTK inhibitors has been shown to be very effective. However, some patients with CLL and other types of B-cell lymphoma may develop resistance to BTK inhibitors by developing mutations in BTK or PLCG2 genes. The NeoLAB BTK Acquired Resistance Panel detects mutations in BTK and PLC-gamma-2 in the peripheral blood plasma cell-free DNA (cfDNA) approximately 2 to 12 months prior to the appearance of overt clinical resistance to therapy. The early detection of potential resistance may alert the treating physician to devise a new strategy for therapy or a combination therapy that may prevent overt resistance. Other indications for testing are for when a patient has few or no circulating cells.
Peripheral blood: 2 x 6 mL EDTA tubes (total 12 mL) or 10 mL in EDTA tube.
Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.