Pleximark^TM

Pleximark™ is a patented blood test to assess the likelihood of acute cellular rejection after renal transplantation.

Purpose

Knowledge about the risk of rejection can be combined with available clinical data to plan additional treatment for your patient. 

Rationale

• Renal transplant rejection is usually suspected because of elevated serum creatinine. Elevated creatinine is also seen with infection and mechanical blockage. A “for cause” biopsy is needed to confirm rejection. Roughly half of “for cause” biopsies do not show rejection.
• Rejection can also occur without affecting serum creatinine, especially if immunosuppression is suboptimal. Surveillance biopsies are performed at predetermined intervals to detect ‘silent’ rejection and assess immunosuppression.
• The Pleximark blood test measures the likelihood of rejection. This knowledge can be combined with clinical information to develop a treatment plan. Benefits include
  • enhancing the diagnostic yield of “for cause’ biopsies,
  • optimizing the frequency of surveillance biopsies, and
  • improving the long-term management of immunosuppression with serial use.

Intended Use

To assess the likelihood of acute cellular rejection after renal transplantation.

Procedure

• Pleximark™ is a functional cell-based blood test, which measures the immune response of recipient lymphocytes to donor lymphocytes in cell culture.
• The test requires whole blood in sodium heparin tubes to be shipped at ambient temperature for overnight delivery to Plexision’s laboratory. Seven-10 ml whole blood are needed from adults, and 3-5 ml are needed from children.
• Recipient T-cytotoxic memory cells, which express the inflammatory marker, CD40 ligand or CD154 are measured with flow cytometry.
• Results are expressed as an index of rejection, which is a measure of the likelihood of rejection.
• Results are reported the day after the blood sample is received at the laboratory, and within two days of obtaining the blood sample from the patient.
• The technology underlying the Pleximark™ test has been evaluated in over 200 children with liver or intestine transplantation and adults with renal transplantation.^2-4
• Pleximark™ uniquely evaluates other types of functional cells for internal quality control.

Performance

The Pleximark™ test is performed in Plexision's CLIA- approved laboratory, and
- Has been evaluated in relationship to “for cause” biopsies in renal transplant recipients.
- Identifies renal transplant recipients experiencing rejection with sensitivity and sensitivity of 88% of specificity of 86%.

Insurance Coverage

Plexision will bill the patient's insurance plan and work directly with the insurer for payment. Plexision will assist with the cost of  Pleximark™, if there is no insurance coverage. For additional information, call 1.855.753.9474 or email info@plexision.com.

How To Order Pleximark^TM

Web: Check ordering information under – http://www.plexision.com
Phone: 1.855.753.9474 or 1.855.PLEXISION
Fax: 1.412.224.2777
Mailing Address: Plexision, Inc. 4424 Penn Avenue, # 202, Medical Building, Pittsburg, PA, 15224-1338.

References

1. US Patent 8759016
2. Am J Transplant. 2009; 9(1): 179-913
3. Surgery. 2009; 146(2): 166-73
4. Pediatr Transplant, 2012; 16(0): 83-91
5. CLIA ID: 39D2042664
6. Transplantation, 2011. 92(4): 433-8