Alternative Name
BTK Inhibitor Acquired Resistance Panel - Liquid Biopsy
Methodology
Molecular
Test Description

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).

Clinical Significance

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.

Specimen Requirements

Peripheral blood: 2 x 6 mL EDTA tubes (total 12 mL) or 10 mL in EDTA tube.

Storage and Transportation

Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.

CPT Code(s)*
81479x1
Turnaround Time

10 days

Level of Service
Global

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.