Frequently Asked Questions

Discover more about Trovagene’s Trovera tests through answers to common questions below.

What are mutations and why are they important to cancer?

Genes are functional stretches of DNA inside each of our cells. They instruct the cells on how to make the proteins our bodies need to function. Changes in these genes are called mutations, which play an important role in the development, growth, and spread of cancer. Certain mutations can cause cells to grow out of control, which can lead to cancer. To learn more about mutations, please visit this website: www.yourgenome.org/facts/what-is-a-mutation.

What is Precision Cancer Monitoring® ?

Trovagene uses the term Precision Cancer Monitoring® (PCM) to describe routine testing of cancer mutations with extremely high sensitivity in a noninvasive fashion. Thus, PCM enables more frequent insights into a tumor’s changes versus biopsies or scans.

What is circulating tumor DNA?

As tumor cells grow and spread, they release their DNA into the blood. This DNA is called circulating tumor DNA (ctDNA) and can be found in urine and blood.

How does knowing my cancer’s mutations help my treatment?

Cancer treatments known as “targeted therapies” are designed to target and stop the actions of specific mutations that may cause the cancer to grow and spread. It is important to know if you have a tumor with one of these mutations so you and your healthcare provider can make the best treatment decisions possible.

Do Trovera tests screen for cancer?

Our tests do not screen for cancer. Our tests detect and quantify specific mutations associated with multiple types of late-stage (metastatic) cancers that are associated with targeted medicines.

Why do Trovera tests use urine for Precision Cancer Monitoring®?

Tissue biopsies can be painful, carry risks, and increase the emotional, physical, and financial burden of cancer care. Simple urine analysis can be done after diagnosis and at any stage in the course of cancer care. Urine analysis provides you and your healthcare provider with information that can aid in decision making regarding treatment and management if your cancer.
– Urine analysis is completely noninvasive
– Samples can be collected from the comfort of the patient’s home
– Information about treatment can be obtained faster and more often. Trovagene’s Trovera noninvasive test detects ctDNA in a patient’s body through a sample of urine.
It’s easy, convenient, and can be done repeatedly and frequently.

How do Trovera tests work?

Through highly sensitive technology, our tests isolate and quantify ctDNA, providing a whole-body view of cancer. With the freedom to test more frequently with minimal impact on patients, healthcare providers can easily monitor tumors and adjust treatment as changes occur.

How do Trovera tests differ from other lab tests?

Traditional cancer tests use tissue biopsy from the actual tumor, requiring patients to undergo a surgical procedure to collect tumor tissue for testing. Trovagene’s Trovera tests are called liquid biopsies because they use common body fluids such as urine and blood to measure ctDNA levels. Our tests quantitatively measure mutations while others may simply tell you the type of cancer you have or whether a certain mutation is present or not. This quantitative measurement is key when determining whether therapies are actually reducing the amount of causative mutations in your body.

For what types of cancer is Trovera testing available?

Trovagene Precision Cancer Monitoring® testing is currently available for EGFR, KRAS, and BRAF genetic mutations, which are found in some of the most common cancers. While Trovera can be used in any cancer type with an associated mutation, there is data demonstrating the clinical value of utilizing Trovera tests in the cancers listed below. KRAS (G12, G13)
– Pancreatic cancer
– Lung cancer
– Colorectal cancer
– Ovarian cancer Trovera BRAF (Blood: BRAF Quantitative V600E [also detects V600K/G/M/R; Urine*: BRAF] Qualitative V600E)
– Melanoma
– Erdheim-Chester disease (ECD)
– Langerhans cell histiocytosis (LCH) *Urine test to be utilized only in patients with histiocytic disorders. Trovera EGFR (Exon 19 deletions, Exon 20 T790M, Exon 21 L858R)
– Lung cancer

At what point in my treatment will my healthcare provider use Trovera tests?

Trovera’s simple urine (and blood) analysis can be used after diagnosis and at any stage in the course of cancer care, including after treatment has concluded. And can inform healthcare providers whether the treatment is working or needs to be changed, as well as whether the cancer is progressing or if minimal disease remains.

How often can Trovera tests be used to monitor cancer treatment?

Because the test can be done on a sample of urine or blood and does not require tumor tissue, Trovera tests can be used repeatedly and frequently to guide treatment decisions and give additional information regarding response to treatment and cancer status.

Do Trovera tests replace tissue biopsy?

No, tissue biopsy is still considered the standard of care. Our tests provide additional information to supplement a tissue biopsy or offer an alternative when tissue biopsy is inconclusive, not available, or not medically advisable.

What is the process for getting a Trovera test?

1. Ask your healthcare provider (HCP) if Trovera is right for you.
2. Trovagene will coordinate sample collection with your HCP.
3. Trovagene will process your sample.
4. Your results will be sent to your healthcare provider.
5. Your healthcare provider will determine the course of treatment.

When do I get my test results?

Test results are typically available to healthcare providers (HCPs) within 10 business days. Your HCP may instruct you to collect your urine sample from home and send it to Trovagene two weeks prior to your appointment. This way, information about the changes in your tumor dynamics can be in your HCP’s hands during your visit.

What should I discuss with my healthcare provider about Trovera?

Whether you and your healthcare provider (HCP) want to identify the mutation driving your cancer, measure mutation levels, or evaluate response to a new therapy, Trovagene can help. Download the Patient/Caregiver Discussion Guide below for help in speaking with your healthcare provider about Trovera tests. > Download the HCP Discussion Guide

How do I find a healthcare provider that uses Trovera tests?

Please call Trovagene client services at 1-888-391-7992 and we would be happy to provide information to your healthcare provider.

How do I prepare for my Trovera test?

The Trovera test is similar to any other urine test you may have taken. There is little that you need to do to prepare, and no need to fast beforehand. You simply collect your urine in the sample cup and we take care of the rest.

Is the Trovera test covered by insurance?

Use of Trovagene ctDNA tests is covered by insurance. They do not add to the cost of a patient’s out-of-pocket cancer care costs, beyond their normal co-pay, coinsurance, and deductible.

Can I get help paying for Trovera tests?

Yes. Trovagene offers financial assistance to qualifying patients through TrovaCares.

What paperwork is required for the TrovaCares?

Patients will need to fill out an application that certifies that they are a United States citizen or legal resident, or a person with a valid visa in the United States and proof of income. Patients will also be asked to provide a W2, paystub, tax return, social security notice, and/or disability paperwork.

What are the federal poverty requirements for TrovaCares?

Up to 4x the federal poverty guidelines based on the Affordable Care Act.

What additional information can the patient supply to qualify for TrovaCares?

Patients can provide monthly expenses, which supplement their income to be able to potentially increase their chances of qualifying for the program.

Who can I contact for more info about TrovaCares?

Please call 888-403-6651 from 6:30 AM – 5:00 PM PST, or email service@trovagene.com.

WANT MORE INFORMATION? CONTACT OUR CLIENT SERVICES TEAM

AT

Tel : 1-888-391-7992