How MiraKind’s Research Registry Helps Patients Access and Shape Impactful New Cancer Tests

When patients are diagnosed with cancer, treatment decisions often have to be made quickly. But many of the newest diagnostic tests that could help guide those decisions are still years away from routine patient care.

At MiraKind, our research registry serves two key purposes. First, it helps us learn directly from patients and their doctors—what they need, what they want, and what makes a test meaningful and useful in practice. Second, it helps bridge the gap between what patients need today and what is not yet widely available in clinical care. This blog explains how that registry model works and its role in how it shapes new molecular diagnostic tests from promising discovery to clinical use.

What is a molecular diagnostic test?

Molecular diagnostic tests analyze biomarkers, such as DNA, RNA, proteins, or other molecules, using samples taken from the body. They can provide doctors and patients with additional information that can help them make the best treatment choices together.

MiraKind’s diagnostic tests are DNA tests that analyze inherited variants associated with cancer risk, prevention, and treatment. They are tests that MiraKind hopes will provide additional meaningful information that could help guide conversations between patients and their doctors as to decisions about cancer care.

Why diagnostic tests take years to reach patients

Unlike drugs, diagnostic tests rarely have a clear path to patients. Many are developed in research settings where funding is limited and the road to clinical use is long and uncertain.

Even when early results look promising, research findings must undergo the expensive, difficult, and time-consuming process of being developed into a validated test in a clinical lab—so that test results can be shared with patients—before moving it into clinical practice.

And then even the most well-validated test must wait years before insurers cover it, putting it out of reach for most patients. There is also the timely task of raising physician awareness so they know about the test and understand when or how to order it.

But equally important, what begins as a good idea can lose its way. By the time a test reaches patients, so much time, money, and effort have been invested that it is often too late to ensure the information it provides is as relevant and helpful to patients and doctors as possible.

The result is a slow journey from discovery to development and then to routine use in patient care—one that can easily wander off of the best path.

How MiraKind’s Research Registry model began

Dr. Joanne Weidhaas knows these barriers better than most. She has spent her career as both a radiation oncologist and a research scientist, holding an MD and a PhD in molecular biology. That combination gave her something rare: the ability to see a scientific discovery and immediately understand what it could mean for a patient sitting across from her in the clinic.

What she didn’t realize was that those were only the first important steps.

When she co-discovered the KRAS-variant in 2006, a genetic variant linked to cancer risk and treatment response, she knew right away that it could help patients. The variant became the finding that led to the foundation of MiraDx, a biotech company she co-founded in 2008.

However, she soon understood the barriers that often delay diagnostic tests from reaching patients. So in 2013, she pivoted her approach and founded MiraKind, a nonprofit foundation.

Through a research registry, she built a model that bridges the gap between test development and clinical readiness, ensuring new diagnostic tests are optimized for helping both patients and doctors while expanding access to promising tests still in development.

This model supports the creation of more effective, clinically useful tests with the greatest potential impact.

How the MiraKind Research Registry works

When a diagnostic test shows promising results in research studies, the next step is learning how it performs for real patients and defining how it can be most useful. The MiraKind Research Registry helps make these goals possible by providing early access to diagnostic tests while collecting information from patients who choose to take part in studies.

Participants complete a simple at-home gumline swab, which is then analyzed using the diagnostic test. Results are shared with the participant and their physician.

At points along the way, participants and their doctors are asked to complete a few short questionnaires about their experience with the test and the information it provided, their treatment journey, and their health outcomes, including, most importantly, how the results informed their care and in what way. Those responses help the team understand what is working and where the test can be improved.

Therefore, patients and their ordering physicians are not simply study subjects—they are contributors, whose experiences help shape the test, ensuring it is fully ready for its best clinical use and application.

From registry to the clinic

Some tests have already completed this journey. The PROSTOX tests, for example, were developed for patients with localized prostate cancer who are considering radiation therapy. Through research registries—one with physicians and one with patients—enough data and feedback was collected to help best direct their application in patient care. Today, physicians can order these tests for eligible patients most likely to benefit from the information.

Currently, following a similar pathway through the MiraKind Research Registry is the PREVIOTOX test, a test that predicts the risk of immune-related adverse events (irAEs) as well as the likelihood of response to a certain type of checkpoint immunotherapy. Currently, programs are being set up for both doctors and patients to access these tests and help define their best use and applications.

Working hand in hand with patients through research and testing

Science moves forward every day, but new tests can take years to reach patients. The gap between a promising discovery and a test doctors can offer in the clinic—one that gives the most important information for both patient and doctor—is real and not an easy problem to solve.

At MiraKind, our goal is to ensure that diagnostic tests do not miss the mark of being helpful nor remain out of reach for years after they are discovered. By connecting patients with ongoing research, the registry helps move these tests forward, in the right way, while keeping patient needs at the heart of the process—learning from patients while offering them helpful information.