Patients

Tutivia™ is a blood test that uses a small tube of blood to help transplant clinicians determine if a patient is high risk for having a current rejection of their transplanted kidney.  This may assist your clinical team with earlier treatment and reversal of an acute rejection.  If the test shows a low risk of rejection the transplant team may decide not to do a biopsy.

The transplant team will determine the right time to perform the test, but a sample for Tutivia™ can be drawn anytime post-transplant. The blood draw for Tutivia™ will likely be done in the transplant clinic and can be performed alone or with other tests requested by the healthcare providers.  For patients who have difficulty coming to the clinic for blood tests, there is a mobile phlebotomy company that can come to the patient’s house to draw their blood for the Tutivia™ test.

Tutivia™ is a standard blood draw and will be drawn post-transplant alone or with other tests ordered by the transplant team. Once drawn, the sample will be processed and then sent to our labs to analyze the blood sample. The result from the sample will then be sent back to the transplant team in the form of a risk score to help determine if a patient’s body is at high risk or low risk for currently rejecting the transplanted kidney.

Biomarkers are different proteins including genes, DNA and RNA found in blood, urine or tissue.  They can help the transplant team determine the likely condition of the transplanted kidney. Some of these tests can tell the transplant team if the kidney is having damage, which may not be specific to the type of damage.  Some tests can specifically tell clinicians if the body is reacting to the kidney in a way that would determine that they are at an increased risk for or already having signs of rejection.

RNA carries instructions from DNA, playing a central role in turning genetic information into proteins and providing an important basis for informative and accurate diagnostics.

Tutivia™ is different than other biomarker tests. It assesses the risk that you are having acute rejection that your body cannot self-resolve. Tutivia™ measures RNA signals in the body that are involved in inflammation (the first thing that happens before there is damage to cells in the body), and the early signaling (communication) of cells responsible for attacking the transplanted kidney, as well as signals that are protecting and repairing the transplanted kidney.   Donor derived cell-free DNA is released into the blood and urine after the transplanted kidney has been damaged. It is not as specific to tell the transplant clinicians what the damage is from. It could be different types of rejection, or it could be from infections that attack the kidney, or anything else that would damage the cells in the kidney including anti-rejection drugs.

The Tutivia™ study design mirrors the current transplant population, including patients with preformed Class I and Class II DSA (Donor Specific Antibodies-patients' antibodies against the donor kidney), and a diverse ethnic population. The study also included higher risk donors normally excluded from biomarker studies.  Currently, the study did not evaluate pediatric patients, or those who have received multi-organ transplants, except those who received a kidney-pancreas transplant at the same time.

Currently no pediatric patients have been evaluated utilizing the Tutivia™ test.  This would be a potential population for future studies.

The test does not measure anything that is known to be affected by food or medications. Currently there are no restrictions prior to having blood drawn to perform the test.

Verici Dx accepts and bills all insurance plans. We strive to ensure Tutivia™ is available and accessible for all patients in need. We will file a claim on the patient’s behalf and will appeal a denial, if necessary. Upon full claim processing and adjudication, a patient may owe a cost share (co-pay, co-insurance, deductible), however we have a financial assistance program to provide further assistance and support if needed.