PERSONALISED MEDICINE FOR BETTER HEALTH
About
Plexision develops cellular biomarkers for personalized diagnosis and drug development in solid organ transplantation and immunological disorders. We also pioneer in R&D projects centered on integrating biomarker targets in all phases of drug development, from preclinical to post-marketing. Plexision’s technology can be adapted to
- Assess disease risk for several immunological disorders.
- Predict the success of a drug for a specific patient.
- Develop dosing recommendations for new immunological drugs.
Our state-of-the-art laboratory is CLIA-certified and located in Pittsburgh, PA.
Contact
- +1 (855) 753-9474
- info@plexision.com
- 4424 Penn Ave., #202, Pittsburgh, PA 15224 USA
Pleximark™
Acute cellular rejection occurs early or late after renal transplantation when T-lymphocytes from the recipient directly attack and destroy cells in the transplanted kidney. This is the most common type of rejection and is also known as T-cell mediated rejection. Acute cellular 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. Up to half of “for-cause” biopsies may not show rejection. Acute cellular rejection can also occur without causing an elevation in serum creatinine, especially if immunosuppression is suboptimal. Surveillance biopsies are performed at predetermined intervals to detect this type of ‘silent’ rejection and assess immunosuppression.
The Pleximark™ blood test measures the likelihood of acute cellular rejection by measuring whether recipient lymphocytes called T-cytotoxic memory cells show increased anti-donor activity.
The Pleximark™ blood test measures the likelihood of acute cellular rejection by measuring whether recipient lymphocytes called T-cytotoxic memory cells show increased anti-donor activity. This activity is measured after stimulating lymphocytes from the recipient with donor or donor-like cells. To determine whether anti-donor activity is increased or decreased, it is compared with activity toward non-donor (reference) cells. Knowledge about the likelihood of acute cellular rejection can be combined with clinical information to develop a treatment plan by:
- Assessing whether elevated serum creatinine indicates an increased likelihood of acute cellular rejection.
- Assessing the adequacy of immunosuppression with serial use.
- Optimizing the frequency of surveillance biopsies.
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CATEGORY
DETAILS
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Assay Category
Lab-developed test, antigen-specific T-cell function.
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Intended Use
To measure the likelihood of Acute cellular rejection after Renal Transplantation.
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Methodology
Stimulation of peripheral blood leukocytes with donor and non-donor cells, flow cytometry.
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Test Report
Available within 30 hours of receiving a blood sample.
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Test Readout
Index of Rejection (IR), the IR is the ratio of the recipient T-cytotoxic memory cell activity toward donor or donor-like cells and reference cells.
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Reference Range
The IR is an absolute number with a range of less than 1.15 to 1.15 or greater.
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Test Interpretation
An IR of 1.15 or more indicates an increased likelihood of acute cellular rejection.
Purpose
Knowledge about the risk of rejection can be combined with available clinical data to plan additional treatment for your patient.
Rationale
- Liver or intestine transplant rejection is usually suspected because of abnormal liver function blood tests, or high stool output, respectively. Such changes are also seen with infection and mechanical blockage. A “for cause” biopsy is needed to confirm rejection. Up to half of all “for cause” biopsies do not show rejection.
- Rejection can also occur without abnormalities in liver function tests or stool output, especially if anti-rejection drug doses are not sufficient. To detect this type of ‘silent’ rejection, biopsies are performed several times, at pre-determined intervals.
- The Pleximmune™ blood test measures the likelihood of rejection. This knowledge can be combined with clinical information to develop a treatment plan. Benefits include:
- Optimizing the frequency of surveillance biopsies.
- Distinguishing rejection from infection in biopsies where such distinctions are difficult.
- Improving the long-term management of anti-rejection medications.
Intended Use
To assess the risk of acute cellular rejection after liver or intestine transplantation in children.
Procedure
- Pleximmune™ 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. A five mL (3 mL minimum) whole blood sample is needed.
- Recipient T-cytotoxic memory cells, which express the inflammatory marker, CD40 ligand, or CD154 are measured with flow cytometry.
- Results are expressed as an immunoreactivity index or IR, which is a measure of the risk 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 if the sample is shipped overnight.
- The Pleximmune™ test has been evaluated in over 200 children with liver or intestine transplantation and adults with renal transplantation.
Performance
The Pleximmune™ test is performed in Plexision's CLIA- approved laboratory and
- Has been evaluated during routine clinical monitoring, in relation to for-cause biopsies and in relation to surveillance biopsies, which are performed at pre-determined intervals.
- Identifies liver or intestine transplant recipients experiencing rejection with sensitivity and specificity of 84% and 80%, respectively.
Benefits
Determining whether rejection is likely is important in deciding
- Whether the right amount of immunosuppression is being given.
- Whether anti-rejection medications can be decreased or not.
- Whether additional tests are needed to confirm rejection.
Knowledge about the likelihood of rejection from the PleximmuneTM test can be combined with other clinical data by your healthcare provider to make clinical decisions.
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 Pleximmune™, if there is no insurance coverage. For additional information, call 1.855.753.9474 or email info@plexision.com
Sample & Handling
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CATEGORY
DETAILS
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Sample Type
Whole blood collected in a sodium heparin (green-top) tube.
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Volume
5 mL in children.
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Transport Conditions
Ship priority overnight, at room temperature. Sample must get to Plexision within 30 hours of phlebotomy.
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Specimen Stability
30 hours at room temperature from the time of phlebotomy.
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Sample Discard Criteria
- Transport time more than 30 hours from phlebotomy.
- Lithium heparin (green-top) tube or ACD (yellow-top) tube.
- Clotted, hemolyzed, frozen, refrigerated, or broken vacutainer seal.
How To Order
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CATEGORY
DETAILS
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Test Brochure
View and download the product brochure here.
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Ordering Tests
Please complete this form, print, and fax to 412-224-2776.
What is Pleximark™?
Pleximark™ is a blood test that helps your healthcare provider determine whether rejection is likely after renal transplantation.
Who can benefit?
Kidney transplant recipients of any age can benefit from the Pleximark™ test.
What is involved in the Pleximark™ test?
The Pleximark™ test must be ordered by your healthcare provider. The test requires a sample of blood of two teaspoons. This sample is to be shipped overnight to Plexision’s laboratory for analysis. Results are sent to your healthcare provider within a day of your sample arriving at the laboratory. Your healthcare provider will help you understand the results.
How long does it take to get results of the Pleximark™ test?
Results are ready within 30 hours after the laboratory receives the blood sample.
How does the Pleximark™ test work?
The Pleximark™ test determines whether the recipient's immune system is reacting excessively toward the transplanted organ. This type of immune response occurs during transplant rejection, and can be measured in a type of white blood cell. When present, this increased immune response tells your healthcare provider whether transplant rejection is likely or not.
How do I interpret the test results?
The results are reported as an Index of Rejection (IR). An index less than 1.15 implies a decreased likelihood of rejection. An index of 1.15 or greater implies an increased likelihood of rejection.
What are the benefits of the Pleximark™ test?
Determining whether rejection is likely is important in deciding whether the amount of anti-rejection medications is enough, whether these anti-rejection medications can be decreased further, or whether additional tests are needed to confirm whether rejection is already present or not. Knowledge about the likelihood of rejection can be combined with other clinical data by your healthcare provider to make clinical decisions.
How do I order the Pleximark™ test?
The Pleximark™ test must be ordered by your healthcare provider. The test requisition form is provided here. The completed form can be faxed to 412-224-2776. If there are any questions, please contact (855) PLE.XISION (753.9474) or 412-224-2504.
Is Pleximark™ covered by insurance?
Plexision will bill your healthcare facility or your insurance plan as indicated on the requisition form. If there is no insurance coverage, Plexision patient assistance plans will assist with the cost of Pleximark™.
1. Patent 8759016
2. Transplantation. 2011 Aug 27;92(4):433-8. PMID: 21747326
3. Transplantation. 2017 Jan; 101(1): 131–140. PMID: 26950712
4. Am J Transplant. 2009 Jan;9(1):179-91. PMID:18976293.
5. Surgery. 2009. Aug;146(2):166-73.PMID:19628070.
Pleximark™ is a lab-developed test, and is not FDA-approved.