ExPeCT™ anti-CD19 (axi-cel) CAR T-cell Assay
Understanding the limitations of anti-CD19 (axi-cel) CAR T cell therapy is critical to realizing the full potential of this treatment approach. Growing experience with these agents has revealed that remissions will be brief in a substantial number of patients owing to poor CAR T cell persistence and/or cancer cell resistance resulting from antigen loss or modulation. The Viracor ExPeCT anti-CD19 (axi-cel) CAR T expansion and persistence assay is a monitoring tool to evaluate and validate the efficacy of anti-CD19 CAR T therapy.
Monitoring for expansion and persistence of CAR T-cells after infusion. Loss of CAR T persistence may indicate relapse or recurrence of leukemia in patients administered CAR T-cell immunotherapy.
About Test
The successes with chimeric antigen receptor (CAR) T cell therapy involving patients with pre-B cell acute lymphoblastic leukaemia (ALL) or B cell lymphomas have revolutionized anticancer therapy, providing a potentially curative option for patients who are refractory to standard treatments. FDA approvals of anti-CD19 CAR T cell products for both ALL and certain types of B cell lymphoma (the first approved gene therapies in the USA). CD19-targeted CAR T cells, which have been engineered to recognize the CD19 cell surface molecule of malignant B cells, show remarkable efficacy in patients with B cell acute lymphoblastic leukaemia. Some patients relapse due to the CAR T therapy not persisting in the body, leading to antigen loss or tumor escape. Growing experience with these agents has revealed that remissions may be brief in a substantial number of patients owing to poor CAR T cell persistence.
ProcedureExtraction of genomic acid from whole blood specimen followed by PCR amplification of CAR and Rnase P targets using real-time PCR methods. An internal control is added to ensure that extraction was performed correctly and that the PCR reaction was not inhibited.
SpecificityInclusivity: axi-cel prepared from multiple donors, specificity: human genomic DNA, FMC63 scFv DNA
24 hours from receipt of specimen, performed Monday - Saturday
| Specimen Type | Test Code | CPT Code | NY Approved | Volume | Assay Range | Special Instructions |
|---|---|---|---|---|---|---|
| whole blood | 33613 | 80299 | Yes | 2.0 mL (min 0.5 mL) |
N/A |
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Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Eurofins Viracor test requisition form must accompany each specimen. Ship specimens FedEx Priority Overnight® to: Eurofins Viracor, 18000 W 99th St. Ste. #10, Lenexa, KS 66219
Causes for RejectionSpecimens beyond their acceptable length of time from collection as listed in the specimen handling.
Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on Eurofins Viracor’s interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Eurofins Viracor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.
References- JHOP - February 2022 Vol 12, No 1 - Review Article, CAR T-Cell Therapy, Lymphoma Drew A. Wells, PharmD, BCPS; Jenna Summerlin, PharmD; Zachery Halford, PharmD, BCOP, BCPPS
- Strategies to enhance CAR‑T persistence. Yue Liu1†, Lingna An1†, Ruihao Huang1†, Jingkang Xiong, Haoyu Yang, Xiaoqi Wang and Xi Zhang Liu et al. Biomarker Research (2022) 10:86 Liu et al. Biomarker Research (2022) 10:86 https://doi.org/10.1186/s40364-022-00434-9
- Safarzadeh Kozani P, Safarzadeh Kozani P and Rahbarizadeh F (2021). Optimizing the Clinical Impact of CAR-T Cell Therapy in B-Cell Acute Lymphoblastic Leukemia: Looking Back While Moving Forward. Front. Immunol. 12:765097. doi:0.3389/fimmu.2021.765097
- Developing and Monitoring a Standard-of-Care Chimeric Antigen Receptor (CAR) T Cell Clinical Quality and Regulatory Program. https://doi.org/10.1016/j.bbmt.2020.03.021 1083-8791/© 2020 American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc.
- Jafarzadeh L, Masoumi E, Fallah-Mehrjardi K, Mirzaei HR and Hadjati J (2020) Prolonged Persistence of Chimeric Antigen Receptor (CAR) T Cell in Adoptive Cancer Immunotherapy: Challenges and Ways Forward. Front. Immunol. 11:702. doi:10.3389/fimmu.2020.00702
- CAR-T Cells: The Importance of Cell Persistence. Sep 13, 2021| Russell Garland https://www.frontiersin.org/articles/10.3389/fimmu.2020.00702/full
- The Leukemia & Lymphoma Society. Immunotherapy Facts. https://www.lls.org/booklet/immunotherapy. Revised December 2019. Accessed October 19, 2021.
- National Cancer Institute. CAR T cells: engineering patient’s immune cells to treat their cancers. https://www.cancer.gov/about-cancer/treatment/research/car-t-cells. Updated: July 30, 2019. Accessed October 20, 2021.
- Brodsky AN. The promise of CAR T cell therapy in 2019 and beyond. Cancer Research Institute [website]. https://www.cancerresearch.org/blog/september-2019/promise-car-tcell-therapy-2019-beyond. Accessed October 15, 2021.
- Peinelt A, Bremm M, Kreyenberg H, Cappel C, Banisharif-Dehkordi J, Erben S, Rettinger E, Jarisch A, Meisel R, Schlegel PG, Beck O, Bug G, Klusmann JH, Klingebiel T, Huenecke S and Bader P (2022) Monitoring of Circulating CAR T Cells: Validation of a Flow Cytometric Assay, Cellular Kinetics, and Phenotype Analysis Following Tisagenlecleucel. Front. Immunol. 13:830773. doi: 10.3389/fimmu.2022.830773
- https://www.cancer.gov/about-cancer/treatment/research/car-t-cells
- Sanber, K., Savani, B. and Jain, T. (2021), Graft-versus-host disease risk after chimeric antigen receptor T-cell therapy: the diametric opposition of T cells. Br J Haematol, 195: 660-668. https://doi.org/10.1111/bjh.17544