“How I Help Patients Access New Diagnostics”

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"How I Help Patients Access New Diagnostics" (Joanne Weidhaas, MD, PhD, MSM) [#138] Brad Power April 9, 2025 "We take people who have cancer, we look at their DNA, and we find out how they would respond if we gave them radiation, if we gave them immunotherapy, if we gave them chemotherapy." – Joanne Weidhaas "I'm a physician scientist. I'm a radiation oncologist.

My view was that I'm going to do good science and become an expert in cancer, which was always my interest. And if I find something, that will be a dream, and it will make it to patients, and that's all that matters. I had no idea how complicated that was." – Joanne Weidhaas "There is a lot to still do. We need patient advocacy groups and everyone's involvement to move things forward together.

" – Joanne Weidhaas Meeting Summary Cancer patients want to know whether a treatment will work and whether it might have toxic side effects. More testing is always going to be preferred because it helps the care team choose the best treatments and minimize side effects. However, patients can face problems with accessing new tests.

Trying to bring new tests to market and help patients access them is amazingly hard for diagnostic companies. Randomized clinical trials — the gold standard for evidence in healthcare — are slow and ill-suited for getting new information to patients quickly enough for them to benefit.

Joanne Weidhaas, MD, PhD, MSM, is uniquely qualified to lead a discussion on using new diagnostic tools to help patients make personalized treatment decisions. Holding several patents, Dr.

Weidhaas is a leader in translational research; a co-founder of MiraDx, a molecular diagnostics company; and a founder of MiraKind, a nonprofit focused on advancing the application of microRNA discoveries for cancer prevention. She is a frequent speaker at medical conferences around the world. Dr.

Weidhaas attended Yale University as an undergraduate, earned her MD and PhD at Tufts Medical School, and completed residency training at Memorial Sloan Kettering Cancer Center. Following concerted efforts to navigate the healthcare system to make new diagnostics accessible to patients, Dr.

Weidhaas attended business school to find out why it was so hard, earning a Master's in Business Management from the Stanford Business School. She found that, in addition to raising awareness in patients and doctors about new tests, doctors must be brought on board to order tests and to bring payers on board.

She put the new tests in a clinical trial to provide access with oversight and created a nonprofit to pay for tests for people who can't afford them. What new tests should you know about that can predict adverse reactions or toxic side effects?

"How I Help Patients Access New Diagnostics" (Joanne Weidhaas, MD, PhD, MSM) [#138] ●Radiation toxicity test : If you have been diagnosed with prostate cancer and are considering radiation treatment, this test predicts whether you will

t that can predict adverse reactions or toxic side effects?

"How I Help Patients Access New Diagnostics" (Joanne Weidhaas, MD, PhD, MSM) [#138] ●Radiation toxicity test : If you have been diagnosed with prostate cancer and are considering radiation treatment, this test predicts whether you will have an 8- to 10-fold risk of severe toxicity, allowing you to choose safer radiation treatment options or other treatments. (MiraDx offers the P ROSTOX test .

) ●Immune checkpoint inhibitor toxicity test : If you are considering getting an immune checkpoint inhibitor (a type of immunotherapy that enhances the immune system's ability to fight cancer by releasing "brakes" on immune cells, allowing them to recognize and attack cancer cells more effectively), this test predicts whether you will have a 10-fold risk of autoimmune-related adverse reactions or side effects, allowing you to choose safer treatment options.

(MiraDx offers the PREVIOTOX test .) How do these novel toxicity tests work? ●Test process: You get a cheek swab, which is analyzed for genetic markers that are compared to known risk patterns to identify whether you are high or low risk for a toxic reaction.

●Scientific foundation : Your microRNA and noncoding DNA are analyzed for systemic stress response to detect potential triggers of adverse reactions. What are the challenges that patients face in accessing new tests? ●Doctor buy-in: Doctors are often required to order tests, and your doctor may not have heard of a new one or know how to interpret test results from it.

They are often only interested in tests that will provide information to help with the decision immediately in front of them, while you may have bigger and longer-term objectives. ●Insurance reimbursement : The test may not have been incorporated into the standard care guidelines. Health insurance companies are slow to reimburse patients for new tests. What can you do to access new tests?

●Consider alternative access routes : Contact the vendor and look into research studies, early-access programs, nonprofit registry studies. ●Advocate for yourself : Ask your doctor about new diagnostic options that could provide personalized treatment insights; be persistent.

●Understand incentives : Recognize that doctors must see a benefit in ordering the test and that insurance ultimately determines reimbursement. ●Spread awareness : Share patient testimonials on the value of tests for predicting outcomes and encourage patient advocacy groups to highlight the potential cost savings and improved patient outcomes from these predictive tests.

●Donate: Support nonprofits that help patients access new tests. What are the challenges that diagnostic companies face in getting a new test to market?

"How I Help Patients Access New Diagnostics" (Joanne Weidhaas, MD, PhD, MSM) [#138] ●Funding: Venture capital firms are primarily focused on making money, which can conflict with the goal of helping patients. They want a

e challenges that diagnostic companies face in getting a new test to market?

"How I Help Patients Access New Diagnostics" (Joanne Weidhaas, MD, PhD, MSM) [#138] ●Funding: Venture capital firms are primarily focused on making money, which can conflict with the goal of helping patients. They want a business that has the potential to become huge, which is more possible in therapeutics — diagnostic services are typically priced much lower.

Pharmaceutical companies offer the deepest pockets for funding new ventures, but testing startups must contort themselves to meet the research and development needs of pharmaceutical companies, which may be different than patients' care needs. ●Insurance reimbursement : Getting insurance to cover a new test is extremely difficult.

Insurance companies are often reluctant to pay for preventive or risk-assessment tests. ●Multiple customers : A successful test must align the interests of three key stakeholders: patients, doctors (who must see a benefit in ordering the test), and insurance companies (which pay for the test).

The incentives for many players in the medical industry are sometimes optimized for their own profits, not what is best for patients. ●Market adoption: Convincing doctors to use a new test and pharmaceutical companies to recognize its value can be challenging.

●Regulatory hurdles : Navigating FDA and Clinical Laboratory Improvement Amendments (CLIA) certification requirements is complex and time consuming. ●Commercialization costs : Developing and marketing a new diagnostic test requires significant financial investment. What are some clever ways to provide patients with better access to new tests?

●Set slow payoff expectations : Find investors, such as friends and family, who are patient and interested in a mission-focused approach rather than profit alone; apply for government grants, such as Small Business Innovation Research (SBIR) grants; avoid venture capital. ●Create a foundation : A nonprofit can enable access for patients who can't afford the full price of the test.

●Create a study: Offer the test through a clinical trial to give patients access; gather valuable real-world data; and provide clinical controls, e.g., an institutional review board, or IRB. (Clinical trials often pay patients or for referrals.

) ●Create value propositions for all customers : Design tests that simultaneously benefit patients (through better outcomes), doctors (through better outcomes and less work), and insurers (through savings); win-win-win. ●Form research partnerships : Work with academic medical centers to offer and develop the test through collaborative studies, and leverage their credibility.

●Be transparent: Educate patients and doctors about test benefits and build trust through open dialogue. ●Engage patient advocacy groups : Speak to cancer support groups and work with them to help organize research that gathers patient insights.

(through savings); win-win-win. ●Form research partnerships : Work with academic medical centers to offer and develop the test through collaborative studies, and leverage their credibility. ●Be transparent: Educate patients and doctors about test benefits and build trust through open dialogue.

●Engage patient advocacy groups : Speak to cancer support groups and work with them to help organize research that gathers patient insights. ●Promote awareness : Help spread information about the test's ability to predict outcomes and its potential to help patients choose the safest treatment option.

"How I Help Patients Access New Diagnostics" (Joanne Weidhaas, MD, PhD, MSM) [#138] How can you learn more?

●See other conversations we have had on new diagnostic tests and bringing them to market, such as: ○"Bringing Novel Immune System Tests from Research to Clinical Use" (Keith Wharton) [#28] ○"The Latest Tests for Personalized Cancer Care" (Tony Magliocco) [#89] ○"How Do You Choose Your Diagnostics?

– A Guide" (Richard Anders and Brad Power) [#100] ●To learn more about toxicity tests, visit the website MiraDx to learn about their research and upcoming presentations at conferences like ASCO, and join their patient registry (through MiraKind) to potentially access tests and participate in their research. ●Contact Joanne Weidhaas at jweidhaas@mednet.ucla.edu.

The information and opinions expressed on this website or platform, or during discussions and presentations (both verbal and written) are not intended as health care recommendations or medical advice by Cancer Patient Lab, its principals, presenters, participants, or representatives for any medical treatment, product, or course of action.

You should always consult a doctor about your specific situation before pursuing any health care program, treatment, product or other course of action that might affect your health.

"How I Help Patients Access New Diagnostics" (Joanne Weidhaas, MD, PhD, MSM) [#138] Meeting Notes KEYWORDS Cancer diagnostics, MiraDx, microRNAs, radiation therapy, immune checkpoint inhibitors, toxicity prediction, patient response, UCLA, clinical trials, nonprofit, patient access, biomarkers, DNA analysis, prostate cancer, autoimmune diseases.

SPEAKERS Joanne Weidhaas (71%), Rick Davis (7%), Brad Power (5%), Richard Anders (5%), Cindy Ness (3%), Roger Royse (3%), Russ Hollyer (3%), Alane Watkins (2%) CHAT CONTRIBUTORS Russ Hollyer, Rick Davis, Michael Nagle, Chris Apfel, Helen, Alane Watkins SUMMARY Joanne Weidhaas, a radiation oncologist and co-founder of MiraDx, discussed her journey in developing molecular diagnostics for cancer.

She highlighted the company's focus on microRNAs, which constitute 80% of DNA and play crucial roles in cancer biomarkers. MiraDx's first test predicts ovarian cancer risk, and their prostate cancer test identifies risk of radiation toxicity, helping patients choose safer treatment paths.

bility. ●Be transparent: Educate patients and doctors about test benefits and build trust through open dialogue. ●Engage patient advocacy groups : Speak to cancer support groups and work with them to help organize research that gathers patient insights. ●Promote awareness : Help spread information about the test's ability to predict outcomes and its potential to help patients choose the safest treatment option.

"How I Help Patients Access New Diagnostics" (Joanne Weidhaas, MD, PhD, MSM) [#138] How can you learn more?

●See other conversations we have had on new diagnostic tests and bringing them to market, such as: ○"Bringing Novel Immune System Tests from Research to Clinical Use" (Keith Wharton) [#28] ○"The Latest Tests for Personalized Cancer Care" (Tony Magliocco) [#89] ○"How Do You Choose Your Diagnostics?

– A Guide" (Richard Anders and Brad Power) [#100] ●To learn more about toxicity tests, visit the website MiraDx to learn about their research and upcoming presentations at conferences like ASCO, and join their patient registry (through MiraKind) to potentially access tests and participate in their research. ●Contact Joanne Weidhaas at jweidhaas@mednet.ucla.edu.

The information and opinions expressed on this website or platform, or during discussions and presentations (both verbal and written) are not intended as health care recommendations or medical advice by Cancer Patient Lab, its principals, presenters, participants, or representatives for any medical treatment, product, or course of action.

You should always consult a doctor about your specific situation before pursuing any health care program, treatment, product or other course of action that might affect your health.

"How I Help Patients Access New Diagnostics" (Joanne Weidhaas, MD, PhD, MSM) [#138] Meeting Notes KEYWORDS Cancer diagnostics, MiraDx, microRNAs, radiation therapy, immune checkpoint inhibitors, toxicity prediction, patient response, UCLA, clinical trials, nonprofit, patient access, biomarkers, DNA analysis, prostate cancer, autoimmune diseases.

SPEAKERS Joanne Weidhaas (71%), Rick Davis (7%), Brad Power (5%), Richard Anders (5%), Cindy Ness (3%), Roger Royse (3%), Russ Hollyer (3%), Alane Watkins (2%) CHAT CONTRIBUTORS Russ Hollyer, Rick Davis, Michael Nagle, Chris Apfel, Helen, Alane Watkins SUMMARY Joanne Weidhaas, a radiation oncologist and co-founder of MiraDx, discussed her journey in developing molecular diagnostics for cancer.

She highlighted the company's focus on microRNAs, which constitute 80% of DNA and play crucial roles in cancer biomarkers. MiraDx's first test predicts ovarian cancer risk, and their prostate cancer test identifies risk of radiation toxicity, helping patients choose safer treatment paths.

Despite challenges in securing venture capital and insurance reimbursement, MiraDx has successfully validated its prostate cancer test and is expanding into immunotherapy toxicity prediction.