FAQs
Learn more about IFN-1 and ELEVATE
General
IFN-1 is a gene that helps regulate the immune system. There is a lot of research connecting IFN-1 activity levels with SLE. Higher levels of IFN-1 correlate with disease severity, risk for progression to Lupus Nephritis, and possibly complications in pregnancy.
In a previous clinical trial, called LIFT, we showed that test kits can be used to monitor IFN-1 levels from home. Understanding your IFN-1 levels may help you and your doctor decide how to best manage your treatment.
Our technology works by measuring RNA levels. When a gene is active, it produces a molecular template called RNA. The RNA encodes instructions for making proteins. Genes have varying levels of activity, and more active genes produce more RNA and more protein.
SLE status has been traditionally monitored by testing proteins, but genomic testing promises more precise characterization of your individual disease. By measuring RNA, we can get an idea of the relative activity of genes that play a role in SLE.
The DxTerity IFN-1 test can be ordered through a doctor.
DxTerity is pursuing an FDA submission of its IFN-1 at-home test.
LIFT was an observational study previously conducted by DxTerity. In LIFT, we measured participant’s IFN-1 levels, and asked them to fill out questionnaires related to their unique experience living with Lupus and share their medical history.
In LIFT, we demonstrated that IFN-1 status (high or low) can be determined from an easy to use at-home test kit. IFN-1 was just the beginning. There are other key genes that relate to SLE disease activity and therapy response, and the ELEVATE study is designed to prove the value of home monitoring.
Elevate
ELEVATE (Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation) is an observational research study that uses participant’s health information and a few drops of blood to better understand what it means to live with and manage lupus. ELEVATE is sponsored by DxTerity Diagnostics, a Los Angeles based genomics company. DxTerity researchers are looking to find a better, easier, and more convenient way for people living with lupus to track and manage their disease from home.
Everyone’s experience living with lupus is unique, from your diagnosis to your flare triggers, and your treatment. By collecting your individual health history, daily experiences, and blood samples from the convenience of home, ELEVATE is working to personalize the next generation of lupus management, so that those diagnosed with lupus will have the knowledge and power to live confidently.
Those who participate in ELEVATE will be asked to provide four blood samples over the course of a year, as well as additional kits during a flare. The flare kits will help us determine if the activity of certain genes fluctuates during flares. We will measure the activity of 51 different genes that research suggests are associated with Lupus.
Participating is easy! ELEVATE is designed for you to do from the comfort of home. You do not have to visit a doctor’s office or clinic to participate.
After you sign up, we will email you a link to download an App, where you will confirm your eligibility, provide Informed Consent for the study, and Medical Records Release.
No! As a member of ELEVATE, you will not have to change anything about your treatment. ELEVATE is an observational research study designed to collect real world information and samples from participants. Through ELEVATE, participants have the freedom to be involved in lupus research without having to change anything about the medications they are currently taking or treatment they are receiving.
Participating in clinical research is an important part of discovering and developing new medicines and ways of treating diseases. Participants like you are the reason medical research moves forward. People join research studies for many reasons, but the most common reason is to help future patients and to move medical science forward. By joining ELEVATE, you will help contribute to lupus research that may result in better ways of managing the disease.
Your privacy is very important to us. Information you share during ELEVATE is handled and maintained in a confidential manner.
All health information that you share with ELEVATE will be maintained within a secure study database. Before your data is used for research, information that could be used to directly identify you is removed, so your identity is kept private.
No, there is no cost to participate in the study. In fact, we will compensate you for your participation (up to $200 if you meet the study criteria and complete all 4 tests and questionnaires) for your time and effort.
A clinical trial is a scientific process that studies the safety and usefulness of new devices, diagnostics, and drugs for medical treatment. Clinical trial patients are given the drug or device to determine if it works as planned.
ELEVATE is an observational research study that does not test a new drug or device and does not provide medical treatment. Observational studies collect information and samples from participants, like you, to support the understanding of medical conditions and development of new products.
The DxCollect® kit was developed by DxTerity, to be used by participants to collect small amounts of blood for DNA, RNA and protein testing. The DxCollect® kit is designed to allow at home collection and shipping from anywhere in the US.
DxTerity is a Los Angeles-based clinical diagnostic company that uses state of the art technologies to analyze patient samples.
Genomics includes the study of how genes interact with each other and with the environment. Genomics looks at both DNA and RNA. Your genomic information can change in response to your disease or from environmental conditions. Genomics can provide critical information on what is happening in your body right now.
ELEVATE is studying Systematic Erythematosus Lupus (SLE or lupus). In order to accomplish this, only people who have been diagnosed with lupus can participate at this time. In the future, DxTerity may sponsor new research studies that you may qualify for. We encourage you to check back with DxTerity about future studies!
The health information you share with ELEVATE will be used to help researchers understand results from your blood samples in terms that translate into disease activity and what it means to live with lupus. Translating lab data into clinical outcomes is important to ensure new treatment options may be available for patients.
Your data will be de-identified and coded; this means researchers will not have access to your name or other personal information that can identify you. Your personal information will be kept in a private and confidential manner.
Informed consent is an important process in research. Before beginning a research study, the participant is given information about the study so they can decide whether to join the study or not. The informed consent process is required by law and designed to protect participants like you, by telling you about a study before you decide to join. A consent form answers questions you may have, such as:
What is the study about? What will I be asked to do during the study? How long will I be in the study? Are there possible risks or benefits to participating? How will my information be kept private? If I start the study, can I decide not to be in the study later? Who can I contact about the study?
Signing a consent form means you agree to participate in the study, but you can stop participation at ANY time if you no longer want to take part in the study. Only those participants that complete the study, which will take approximately 1 year, will receive a $150 gift card.
While we are hopeful we can provide you with some important test results during the study, we are not certain at this point. We want you to have as much information as possible to help you manage your disease, but cannot promise any test results at this time.
Researchers will use the information from your medical records to confirm key information about your disease like your diagnosis, medications, and past health events. Your medical records will help us to better understand how your health history links with your health condition.
You can print the Informed Consent Form to take to your doctor, as well as direct them to theelevatestudy.com/. You and your doctor are welcome to contact DxTerity if you have any additional questions about the study. Additional information regarding IFN-1 and DxCollect® kits can be found at DxTerity.com.
If you would like to get your Doctors’ opinion on this please download this sheet.
Email: [email protected]
