“How Do You Choose Your Diagnostics – A Guide”

“How Do You Choose Your Diagnostics? – A Guide” (Richard Anders and Brad Power) [#100] Richard Anders and Brad Power June 5, 2024 “The Cancer Patient Lab … is a ‘user group’ of people who are trying to collaborate and figure out how collectively to improve everybody's understanding of what they deal with as patients.

” – Richard Anders “When you have all of that information coming at you, how do you make sense of it? How do you interpret it, especially in the face of tremendous stress, time pressures, and the need to understand and act on it quickly?

” – Richard Anders “If we could create the Services Guide such that it is the gold standard, not just the gold standard for patients, but also for clinicians, insurance companies, pharma, and other life sciences companies, then you can bring these constituents together, such that they're having a conversation around the value of these service providers.

” – Brian McCloskey “I don't see anything that's more compelling in medicine right now than to actually pursue something like this. This is really, really important. We're onto something.” – Brian McCloskey Meeting Summary Cancer should not be a spectator sport.

Actively engaging in your care can give you and your caregivers more control over your life, a better understanding of what to expect and how to deal with it, and even, perhaps, better outcomes. But to do this, you must take a page from the playbook we’ve all grown up with when buying a car or a house. You need to become an educated consumer and shop around for these services.

To help patients and caregivers (and physicians!), Brad Power, co-founder and CEO of the Cancer Patient Lab, has assembled a robust guide that identifies services providers in over sixty areas of cancer care. These range from mental health and financial experts to care consultants and data management services. One of the most important of these categories is testing and diagnostic services.

Testing and diagnostic services provide the data that can uncover new treatment options and help you make decisions between treatment options. Richard Anders is uniquely qualified to help patients, caregivers, and physicians navigate complex diagnostic decisions.

Richard is an active member of the Cancer Patient Lab community, the Founder and Executive Director of Mass Medical Angels, one of the country’s leading life-science focused angel groups, and Managing Director, Rubin/Anders Scientific. For ten years he taught life science entrepreneurship at the Sloan School at MIT and the Harvard/MIT Health Sciences and Technology MD-PhD program.

Why should you get as many diagnostic tests as possible to guide your cancer treatment?

“How Do You Choose Your Diagnostics? – A Guide” (Richard Anders and Brad Power) [#100] Diagnostic tests provide the data to help you select your best treatments. Historically, your treatment decisions were guided by a stained image of your tumor tissue and scans. Then “next genera

r treatment?

“How Do You Choose Your Diagnostics? – A Guide” (Richard Anders and Brad Power) [#100] Diagnostic tests provide the data to help you select your best treatments. Historically, your treatment decisions were guided by a stained image of your tumor tissue and scans. Then “next generation sequencing” became available around 2011 to analyze the DNA of your tumor tissue and identify genetic mutations.

In the future, your tissue images will be integrated with many diagnostic tests (next generation sequencing, RNA sequencing, proteomics, spatial transcriptomics, metabolomics, single cell analysis and potentially functional studies on animal or cell-based models) leading to more personalized treatment guidance.

Biomarkers will be identified which will select which treatments might work best, and predict your likely outcomes. Multiple fluorescence stains will be applied to tissue and stacked to visualize your tumor and its microenvironment.

Artificial intelligence will be applied to your scans and other test data and do a better job than a pathologist at interpreting them and predicting your prognosis and drug response. What are the challenges that patients, caregivers, and physicians face in navigating possible diagnostic tests?

●Awareness: There are many new tests coming to market that few people know exist or how they can help guide treatment decisions. Everyone, including physicians, struggles to keep up with the rapidly evolving landscape of tests and treatments. ●Understanding: Navigating testing options is a complex area, to put it mildly. As consumers we know what a house looks like or how a car should handle.

But what do we know about the “AUC” (area under the curve, a measure of the usefulness of a model) of a diagnostic test, “RNA-seq” (ribonucleic acid sequencing, a laboratory technique to reveal the presence and quantity of RNA molecules in a biological sample), “tumor heterogeneity” (differences in cancer cells within tumors or between tumors), or “immunocompetent mice” (mice that have the ability to produce a normal immune response)?

To be an educated consumer in the diagnostic field requires a whole different order of understanding. ●Selection: Every cancer patient should get standard tests for their disease, e.g., an EGFR test for lung cancer, but many do not. Rapid growth of targeted treatments has created an explosion in demand for companion diagnostics. What tests should you get?

How can you access all of the tests that are needed to point to your personalized treatments? ●Interpretation: Up to 30% of patients have an incorrect or incomplete diagnosis. Over 60% of oncologists say they have difficulty trying to understand what tests to use, and what the results mean.

Your doctor won’t order a test unless they know how to interpret it and how it will be used to guide your treatment. It is very confusing for anyone trying to keep up with this.

Over 60% of oncologists say they have difficulty trying to understand what tests to use, and what the results mean. Your doctor won’t order a test unless they know how to interpret it and how it will be used to guide your treatment. It is very confusing for anyone trying to keep up with this.

Does your doctor know what to do with all the possible test results, such as RNA sequencing and proteomics? Different test results may conflict. What do you do if the tests seem to contradict each other? How do you bring together all of your test results into a comprehensive view of your disease and which treatments are best for you?

●Expense and Reimbursement : New tests are not reimbursed for clinical use. How do you pay for the additional tests and test integration?

“How Do You Choose Your Diagnostics? – A Guide” (Richard Anders and Brad Power) [#100] ●Tissue: Many of the tests require tumor tissue, including some that require fresh tissue. ●Conservatism: Under the guidelines physicians use, new technologies are treated very cautiously and adopted slowly. Physicians are trained under these guidelines and do not deviate from them lightly.

But some – especially in more difficult situations – are willing to go to the powers that be to push for something outside the guidelines. What are the potential benefits of a guide to diagnostic tests?

●Give you more data to make better data-driven treatment decisions ●Provide a standard reference so that various stakeholders (patients, caregivers, physicians, diagnosticians, payers) can build on it to collaborate on driving better patient outcomes ●Provide a tool to help you be a more knowledgeable patient, which will give you more power and influence as you seek the best care What questions should a consumer guide to cancer diagnostics answer?

●Where does this test stand in the FDA regulatory cycle? Is this test for “research use only”, a “Lab Developed Test”, in clinical trials, or FDA-approved for commercial use? ●How long has this test been around? ●Whether or not it’s approved, are there [many] clinicians who are using it? ●Is this a test which changes treatment? ●Is this a test which applies to certain types of cancers?

What kind of cancer is this for? ●What stage of cancer is this for? ●Is this test ideally for a particular stage in treatment, e.g., early detection, diagnosis, or monitoring progression? ●Is this standard of care or not standard of care? Is this test in the NCCN guidelines? ●How much does this test cost? Is this test reimbursed by insurance? If so, what do you need to do to get it reimbursed?

●What do you need to provide to obtain the test (tumor samples? Blood? Other?) Is the facility where you're getting your care able/willing to provide this? Is the test otherwise available at your facility? ●Must your clinician prescribe this test or is it available directly to you as a consumer?

ty trying to understand what tests to use, and what the results mean. Your doctor won’t order a test unless they know how to interpret it and how it will be used to guide your treatment. It is very confusing for anyone trying to keep up with this. Does your doctor know what to do with all the possible test results, such as RNA sequencing and proteomics? Different test results may conflict.

What do you do if the tests seem to contradict each other? How do you bring together all of your test results into a comprehensive view of your disease and which treatments are best for you? ●Expense and Reimbursement : New tests are not reimbursed for clinical use. How do you pay for the additional tests and test integration?

“How Do You Choose Your Diagnostics? – A Guide” (Richard Anders and Brad Power) [#100] ●Tissue: Many of the tests require tumor tissue, including some that require fresh tissue. ●Conservatism: Under the guidelines physicians use, new technologies are treated very cautiously and adopted slowly. Physicians are trained under these guidelines and do not deviate from them lightly.

But some – especially in more difficult situations – are willing to go to the powers that be to push for something outside the guidelines. What are the potential benefits of a guide to diagnostic tests?

●Give you more data to make better data-driven treatment decisions ●Provide a standard reference so that various stakeholders (patients, caregivers, physicians, diagnosticians, payers) can build on it to collaborate on driving better patient outcomes ●Provide a tool to help you be a more knowledgeable patient, which will give you more power and influence as you seek the best care What questions should a consumer guide to cancer diagnostics answer?

●Where does this test stand in the FDA regulatory cycle? Is this test for “research use only”, a “Lab Developed Test”, in clinical trials, or FDA-approved for commercial use? ●How long has this test been around? ●Whether or not it’s approved, are there [many] clinicians who are using it? ●Is this a test which changes treatment? ●Is this a test which applies to certain types of cancers?

What kind of cancer is this for? ●What stage of cancer is this for? ●Is this test ideally for a particular stage in treatment, e.g., early detection, diagnosis, or monitoring progression? ●Is this standard of care or not standard of care? Is this test in the NCCN guidelines? ●How much does this test cost? Is this test reimbursed by insurance? If so, what do you need to do to get it reimbursed?

●What do you need to provide to obtain the test (tumor samples? Blood? Other?) Is the facility where you're getting your care able/willing to provide this? Is the test otherwise available at your facility? ●Must your clinician prescribe this test or is it available directly to you as a consumer? ●What degree of proof is there for this test?

What is the level of evidence or confidence in this test?

lling to provide this? Is the test otherwise available at your facility? ●Must your clinician prescribe this test or is it available directly to you as a consumer? ●What degree of proof is there for this test? What is the level of evidence or confidence in this test? ●What is the evidence you can bring to justify this test to a treating physician?

●Does the testing company provide patient support (financial or navigation services)? ●Can the test provider interpret across multiple tests to inform treatment recommendations? ●What has been the experience of other patients and caregivers using this test provider? How can you learn more?

●Read our discussion with Tony Magliocco, founder and CEO of Protean BioDiagnostics on using diagnostic tests to guide personalized treatment here.

“How Do You Choose Your Diagnostics? – A Guide” (Richard Anders and Brad Power) [#100] How can you help us develop the cancer diagnostics services guide? ●Volunteer to join our working group to further discuss needs, collect ideas, define work products, develop our methodology, and provide oversight for the Services Guide project – email Brad Power at bradpower@cancerpatientlab.org.

●Review the transcript, slides, or video recording of this discussion, and add questions and comments ●Request a copy of the services guide; provide feedback; help build out the sections ●Provide introductions to diagnostic companies that might be interested in this project and being included in the guide ●Provide introductions to medical oncologists who might like to contribute clinical perspectives 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 Do You Choose Your Diagnostics?

– A Guide” (Richard Anders and Brad Power) [#100] Meeting Notes KEYWORDS patients, oncologist, clinicians, people, brad, cancer, medical oncologist, guide, started, diagnostic, services, service providers, working, nccn guidelines, talked, reimbursed, doctor, questions, care, thought SPEAKERS Richard Anders (31%), Glenn Sabin (15%), Brian McCloskey (13%), Brad Power (11%), Jeffrey Dwyer (8%), Allen Morris (7%), Jeff Krolick (6%), Chris Apfel (5%), Jane Wilkinson (3%), Robert Gurmankin (2%) SUMMARY Navigating complex cancer diagnosis and treatment information is hard for patients and caregivers.

A personalized oncology service providers database and a comprehensive services guide for cancer patients and caregivers could help. New diagnostic technologies need to be adopted and integrated into clinical practice.

sis and treatment information is hard for patients and caregivers. A personalized oncology service providers database and a comprehensive services guide for cancer patients and caregivers could help. New diagnostic technologies need to be adopted and integrated into clinical practice.

The adoption of diagnostic technologies depends on collaboration, clinical validation, regulatory approval, and evidence-based medicine. OUTLINE Creating a guide for cancer diagnostics, drawing parallels with computer industry history.

●Richard Anders discussed the history of user groups in the computer industry and drew parallels with cancer patient communities, highlighting their importance in self-education and collaboration. ●He noted the challenges of making sense of complex information in the face of uncertainty and time pressure, particularly for cancer.

●The evolution of the personal computer industry could have parallels to the evolution of patient driven care in the health industry. The personal computer magazine industry could have parallels to the development of tools such as a guide to cancer diagnostics. ●Brad Power has developed a comprehensive guide to cancer services, which Richard hopes will supplement and deepen the conversation.

Cancer patient resources and service providers. ●Brad Power shared an evolving list of 60+ services for cancer diagnosis and treatment, including sound therapy. ●Richard Anders mentions a working document detailing service providers for immune system analysis, which they are willing to share with interested parties.

Categorizing medical diagnostic tests based on their stage of development (research vs commercialized).

“How Do You Choose Your Diagnostics? – A Guide” (Richard Anders and Brad Power) [#100] ●Allen Morris discusses the importance of categorizing established treatments by how long they have been used. ●He highlights Natera's commercialization of minimal residual disease tests in colorectal cancer. Cancer treatment options and the importance of staying up-to-date with research.

●Jane Wilkinson thinks that a guide can be helpful equally for patients and physicians. ●Patients can educate oncologists, who need continuous learning and must adapt to new information. ●Richard Anders notes that clinicians struggle to keep up with the rapidly evolving landscape of medical research and treatments. Challenges in getting new cancer diagnostic tests approved and used by clinicians.

●Chris Apfel suggests bringing an oncologist to the meeting to provide valuable insights. ●Oncologists are bound by NCCN guidelines, which can limit their ability to innovate. ●Robert Gurmankin's oncologist is willing to try a standard of care drug despite its age, citing a functional test with promising results.

●Clinicians discuss challenges in prescribing and reimbursing personalized cancer treatment. Patient-led guide for cancer treatment options.