Liquid Biopsy for Cancer: What Patients Need to Know

•Less invasive than traditional tissue biopsies, especially if you are medically fragile or cannot undergo surgical procedures, minimal discomfort; less expensive than a tissue biopsy; can increase testing frequency; especially helpful when tissue biopsy is difficult or impossible

•Monitor your cancer progression and treatment response by tracking circulating tumor DNA in your blood; early detection of potential cancer recurrence or resistance mutations before they become clinically apparent; determine when to change therapeutic approaches

•Comprehensive genomic profiling that can help guide precision medicine treatment decisions; particularly useful if you have non-small cell lung cancer

•Multi-cancer early detection , allowing for screening and intervention at earlier stages when treatment is most effective How can liquid biopsies complement other tests?

•Liquid biopsies can offer a more comprehensive tumor profile by detecting genetic variations across multiple tumor sites, which a single tissue biopsy might miss.

•For monitoring treatment response, liquid biopsies allow frequent, non-invasive tracking of tumor mutations and minimal residual disease.

•In cases of metastatic cancer with unknown primary origin, liquid biopsies can help identify potential tumor origins and guide treatment decisions.

•Liquid biopsies can be used alongside traditional imaging and tissue tests to provide a more complete picture of your cancer status, potentially detecting changes earlier than other methods. What are the challenges of false positives and false negatives and other potential biases in liquid biopsies, especially for multi-cancer early cancer detection?

•False positives can ca cause psychological distress for patients, may lead to unnecessary additional medical procedures, and raise public health and reimbursement concerns.

•False negatives can provide a false sense of security, might delay critical cancer interventions, and reduce patient trust in the technology.

•Key challenges include minimizing false positives (maximizing “sensitivity”) and minimizing false negatives (maximizing “specificity”), determining appropriate patient populations for testing, and developing tests that provide actionable clinical information.

•Current multi-cancer early detection tests are still evolving. They're not yet ready to replace existing screening methods like mammograms. Research is refining biomarker identification and establishing clinical standards. Early detection may provide lead time, but not improve your outcome. How should you decide which service provider you should select for your liquid biopsy?

•Clinical evidence: Look for providers with robust published research and clinical validation studies for your specific cancer type, consult with your medical team

•Test specificity: Evaluate the test's performance in terms of sensitivity and specificity for your particular diagnostic or monitoring needs

•Comprehensiveness : Check the breadth of genomic profiling and the number of cancer types the test can detect

•Regulatory approvals : Prefer providers with FDA clearance or CE marking

•Insurance coverage : Verify if the test is reimbursed by your insurance

•Turnaround time: Consider the speed of test results

•Cost: Compare pricing across different providers

•Reputation: Research the provider's track record and reviews from medical professionals How can you access liquid biopsies, e.g., tips for persuading your doctor that you should get a liquid biopsy, navigating reimbursement?

•Research specific liquid biopsy tests relevant to your cancer type or situation, including talking with peers

•Bring scientific literature and recent studies to your doctor demonstrating the test's potential value

•Ask specifically about molecular profiling and whether a liquid biopsy could provide additional insights into your treatment

•If your doctor is hesitant, request a referral to an oncologist more familiar with liquid biopsy technologies

•Check with your insurance provider about coverage - some tests are now being reimbursed, especially for certain cancer types like non-small cell lung cancer

•Consider clinical trials that might provide access to liquid biopsy testing How can you learn more about liquid biopsies in cancer care?

•Visit the BLOODPAC website for resources and educational materials; offer to provide the patient perspective on the development and implementation of liquid biopsy technologies

•Contact Lauren Leiman at lauren@bloodpac.org or Jenn Dickey at jennifer.dickey@labcorp.com

•Review educational resources from cancer research organizations that explain the current uses and potential of liquid biopsies; read scientific publications from diagnostic companies; follow ongoing clinical trials and research; attend medical conferences that feature liquid biopsy research

•Consult with oncologists who are familiar with the latest liquid biopsy technologies

•Join patient advocacy groups focused on cancer research

•See previous webinars we have had on liquid biopsies, such as

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•“Using Predictive Biomarkers and Liquid Biopsies to Personalize Treatment for Prostate Cancer”

•“Using RNA Sequencing to Guide Treatment Decisions for Advanced Cancer Patients“ 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. For the video recording of this conversation, please see here. For a transcript of the conversation, please see here. For the slides, please see here. Meeting Notes KEYWORDS Liquid biopsy, cancer patient, blood profiling, White House Cancer Moonshot, frameworks, standards, data aggregation, regulatory issues, reimbursement, accessibility, early detection, multi-cancer, clinical trials, patient advocacy. SPEAKERS Jenn Dickey (29%), Lauren Leiman (26%), Peter Kuhn (10%), Rick Davis (8%), Allen Morris (8%), Roger Royse (5%), Richard Anders (4%), Paul Van Camp (4%), Dinesh Kumar (2%), Sandra Balladares (1%), Ari Akerstein (1%), Jeff Waldron (1%) CHAT CONTRIBUTORS Saed Sayad, Russ Hollyer, Alexander Lalov, Len Sierra, Ari Akerstein, Helen, Rick Davis, Paul Van Camp, Jenn Dickey, Dinesh Kumar, Kamran, Jeff Waldron, Lauren Leiman, Peter Kuhn, Richard Anders, Allen Morris SUMMARY Lauren Leiman and Jennifer Dickey discussed the advancements and challenges in liquid biopsy technology for cancer patients. BLOODPAC, led by Leiman, aims to accelerate the development, approval, and accessibility of liquid biopsy technology. They highlighted the importance of creating frameworks and standards, aggregating data, and addressing regulatory and reimbursement issues. Dickey explained the three primary uses of liquid biopsy: diagnostic biopsies, monitoring therapeutic progress, and early cancer detection. They emphasized the need for clinical evidence and the role of patient advocacy in promoting these tests. The discussion also touched on the challenges of false positives and false negatives in early detection tests. OUTLINE Introductions and Overview of BLOODPAC

•Lauren Leiman provided an overview of BLOODPAC, and introduced her colleagues Cheyenne Jankowicz, Donna Albers, and Doris Lopez.

•BLOODPAC started with the White House Cancer Moonshot and its mission to accelerate the development and accessibility of liquid biopsy technology for cancer patients.

•BLOODPAC's workflow includes regulatory, reimbursement, and education issues, with Peter Kuhn and Jennifer Dickey playing key roles.

•BLOODPAC's mission is to create frameworks and standards for the community and aggregate data to support these standards.

•BLOODPAC has grown from an initial group of 20 organizations to over 74, including private payers, showing progress in the field.

•The organization focuses on three main areas: evidence generation, stakeholder engagement, and working groups.

•Jennifer Dickey leads several working groups, including the regulatory Working Group and the blood collection kit project. Defining Liquid Biopsy and Its Uses

•Jennifer Dickey defined liquid biopsy as using biofluids, primarily blood, to examine circulating tumor DNA or cells for clinical examinations.

•Liquid biopsy is less invasive than traditional biopsies and can help guide therapeutic decisions, especially for medically fragile patients.

•The primary uses of liquid biopsy include diagnostic biopsies, monitoring therapeutic progress, and molecular residual disease detection.

•Future uses include multi-cancer early detection, assessing apparently healthy individuals for early cancer detection. Challenges in Developing Liquid Biopsy Technologies

•The challenges in developing liquid biopsy technologies include the time, expense, and clinical trials required.

•The field evolves slowly, and it takes time to align analytical and clinical standards.

•BLOODPAC aims to align on lexicon, analytical performance studies, and clinical endpoints to support small companies and new technologies.

•The organization's value lies in creating a pre-competitive space for collaboration and framework development. Patient Voice and Advocacy

•Rick Davis raised concerns about the lack of patient voice in BLOODPAC, emphasizing the importance of patient advocacy.

•Lauren Leima acknowledged the challenge and explained BLOODPAC's focus on developing standards and frameworks for the industry.

•BLOODPAC partners with patient advocacy groups like Lungevity and the Prostate Cancer Foundation to ensure patient input.

•They aim to educate clinicians on the use of liquid biopsy tests, with a focus on accessibility and education. Recommendations for Liquid Biopsy Tests

•Allen Morris asks for recommendations on liquid biopsy tests in general, and specifically for each of the spaces - early detection, minimal residual disease monitoring, etc?

•Jennifer Dickey and Lauren Leiman discussed the challenges in recommending specific companies, emphasizing the importance of clinical evidence and collaboration.

•Comprehensive genomic profiling is needed and BLOODPAC is supporting the development of these tests.

•Patient advocacy is important in promoting the use of liquid biopsy tests. Minimal Residual Disease and Clinical Evidence

•Allen Morris discussed the use of minimal residual disease tests, particularly for colorectal cancer, and the need for clinical evidence - [and unfortunately the specificity of my comment was lost on my critics.]

•Clinical evidence is important and BLOODPAC plays a role in supporting the development of these tests.

•False positives and false negatives in liquid biopsy tests present challenges. Future of Minimal Residual Disease

•Sandra Balladares asked about the future of minimal residual disease as standard of care.

•Minimal residual disease will likely be adopted on a tumor-specific and stage-specific basis.