Now, a non-invasive alternative to surveillance biopsies for kidney transplant recipients

TruGraf® Kidney is a Non-Invasive Blood Test
That Rules-Out Rejection Early

The Facts About Silent Subclinical Rejection

~25% of stable kidney transplant patients are silently rejecting(1)

~35% of patients experienced silent rejection in the first 2 years(2)

On surveillance biopsy, graft tissue from ~80% of stable patients with silent rejection is classified as “borderline”(1)

Congratulations on your transplanted kidney!

We know it took a lot to get you to this point, between the waiting, the surgery, and the recovery.

At Transplant Genomics, we care about the health of your kidney, too – we want to do everything we can to support your medical team in making the best possible treatment decisions.

We want you to enjoy an excellent quality of life for many years to come. That’s why it’s important to follow the advice of your transplant team and have checks along the way to give you confidence that you are on the right track!

What is kidney rejection?

Your body’s immune system protects you against biological entities that it views as ‘foreign’ to you. Your immune system will recognize your transplanted organ as a foreign entity and will attack it to eliminate the intruder. The anti-rejection medications you take (known as immunosuppression) can help your body accept your new kidney.

Common signs of rejection may include fever and other flu-like symptoms; pain, tenderness, and swelling in the kidney area; weight changes; a decrease in urine; and fatigue.

But I don’t feel sick now. So, my kidney is OK, right?

These symptoms are signs of clinical rejection, also called acute rejection. By the time your body shows these signs, damage has already been done to your kidney.
Research shows that the rejection process begins well before symptoms develop, with what we call “silent” rejection, or subclinical acute rejection (subAR). In subAR, you will likely feel normal.

Ruling out “silent” rejection is complicated, and before now required an invasive biopsy to diagnose. We now have the technology to give you confidence that you have ruled out this subclinical rejection without the expense and pain of a biopsy!

Won’t other tests tell if my kidney is “silently” rejecting?

Several tests can assess your kidney health, including your serum creatinine and immunosuppression drug level. Research shows that serum creatinine is a late indicator of kidney injury, meaning we recognize the need for earlier surveillance opportunities.

Many other kidney rejection tests are designed to rule out acute rejection, when damage has already been done to your kidney.

A biopsy can ultimately diagnose subAR, but biopsies are painful and invasive. That’s why we created TruGraf Kidney — a non-invasive test that rules-out “silent” subclinical acute rejection as early as possible.

Alright — so what is TruGraf?

TruGraf is a blood-based test that can reassure you that you are not experiencing “silent” rejection.

It can be used every 1-3 months to provide your clinician with valuable data about your kidney’s health – and, best of all, without the need to undergo a painful and invasive surveillance biopsy.

What is a TruGraf test like?

The TruGraf test is simple: a phlebotomist will take a small amount of your blood, just as they would for any other routine blood test. And that’s it.

Your sample is then sent to our lab for analysis, and your results are quickly sent to your clinician.

Although TruGraf is not any more invasive than your usual lab tests, the result can give you the confidence that you never had before!

How does the TruGraf test work?

TruGraf is a gene expression profile test that looks at the 120 genes that increase or decrease to correspond with your immune system response. We look at the gene expression profile from your blood sample and compare it against a reference profile to see whether your profile most closely matches a profile free from rejection or not. The reference profiles were determined from several thousand samples from several hundred transplant recipients.

What results will I get from the TruGraf test?

TruGraf results are simple; you will either receive a TX (“Transplant eXcellence”) result if your genes more closely match the profile associated with no subclinical rejection, or a Not-TX result if your genes do not align with this group.

What do I do if I get a TX result?

Congratulations! You are on the right track and can be confident with a TX result that you have achieved Transplant eXcellence! Continue to achieve this confidence for the life of your kidney with routine surveillance testing using TruGraf!

Keep up with your immunosuppression, diet, exercise, and hydration, and other guidance from your physician. If at any time you start to experience symptoms of active rejection, contact your clinician immediately.

What happens if I get a Not-TX result?

Don’t panic! Your provider may repeat the test or continue to monitor your lab work results closely. In some cases, your clinical team may recommend a biopsy to determine if repeated not-TX results combined with other clinical factors is truly indicative of subAR.

How do I get a TruGraf test?

Your clinician can order a TruGraf test.

  1. A TruGraf blood collection kit will be mailed to your home, or you can pick one up at your transplant center or medical office. Your provider may also request a Labs@HOME mobile phlebotomy draw.
  2. You then take the TruGraf kit to a hospital or commercial lab service near you, just as you would for all your other blood work.
  3. After a small sample of your blood is drawn, the kit is shipped overnight to our certified lab; the sample is analyzed; and your results are sent to your clinician for review.

Talk with your your trusted healthcare provider to see if TruGraf may be helpful in your own personal transplant care.

Do I have to go to a lab for the test?

No! If you have any reason to prefer having your blood drawn in your own home, you can take advantage of our Labs@HOME mobile phlebotomy service, where we send a trained and qualified phlebotomist to your home to perform the blood draw safely and conveniently. They send your sample to us for testing, just as if you had your blood drawn in a lab.

Will my insurance cover TruGraf?

Transplant Genomics is committed to providing testing ordered and deemed medically necessary by a provider, regardless of our network status with private insurers.

Our Patient Financial Assistance program is designed to tailor solutions for uninsured or under-insured patients based on individual circumstances.

TruGraf will be reimbursed for kidney transplant recipients covered by Medicare. If you have private insurance we will work with your medical care team to receive prior authorization for TruGraf.

Who is Transplant Genomics?

That’s us! Transplant Genomics is an extraordinary team of passionate experts in clinical research, laboratory science, patient care, business operations, and commercial excellence who have the opportunity to demonstrate their commitment to improving lives for transplant patients every day. Our patient-first philosophy guides everything that we do to fulfill our vision and mission:

We are committed to improving organ transplant outcomes through molecular diagnostic tests that reliably rule out early signs of transplant injury and empower providers to optimize treatments for their patients.

Wondering what “silent” rejection is, and why it’s important to catch it early? Visit our patient education website and Get Ahead of Rejection!

 

 

Are you a transplant recipient, donor, or caregiver who is passionate about sharing your story and improving the transplant community? We invite you to join TGI’s Patient Ambassador Program!