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SAGE Oncotest™ Information
Thank you for choosing the SAGE Oncotest™ from SageMedic Corp, Redwood City, CA (SAGE). SAGE is a patient and physician advocacy-driven company, with the mission to help patients and oncologists make more informed decisions together, significantly improving cancer treatment outcomes.
You are unique, as is your response to treatment you may receive. Informed by our very personal experience with cancer, we have developed the SAGE Oncotest™, which is aimed at helping your oncologist identify better treatments for your specific type of cancer.
Rather than using formalin-fixed tissue of dead cancer cells (used by genomic testing or other tests), the SAGE Oncotest™ uses your live cancer tissue specimen that may be sensitive or resistant to various treatments, using machine learning-enabled live 3D cancer profiling. This unique approach allows oncologists and patients to identify the most effective therapy. This complements and goes well beyond genomic testing, which works in only 1 in 4 patients. SAGE provides an improved process for your oncologist to assess your personal situation: SAGE Oncotest™ examines how your live cancer specimen responds to various treatment options, rather than subjecting your body to ineffective treatments and unnecessary side-effects.
The process is simple. You and your oncologist will inform SAGE when you are scheduled for surgery or a special biopsy and SAGE will provide the shipping kit and handling instructions. A live sample of specimen materials from the procedure, ordered by your oncologist, will be obtained. The specimen will be shipped directly to SAGE’s laboratory overnight. SAGE’s specially trained lab technicians will process your specimen to create hundreds of microtumors, which are very similar to your original cancer. Based on your oncologist’s request, a panel of FDA-approved drugs will be tested on your microtumors, enabling your oncologist to go “beyond standard of care while staying within standard of care.”
Your oncologist will then receive a detailed report about your ex-vivo tumor sensitivity and resistance profile within 10 days.
The SAGE Oncotest™ is performed in a California-registered laboratory, which holds CLIA (Clinical Laboratory Improvement Amendments) Accreditation, CLIA ID: 05D2236809. The Laboratory Director is Gerald Weiss, MD, FCAP. Therefore, SAGE Oncotest™ meets all state and federal requirements essential for clinical decision making. However, insurance companies may classify SAGE Oncotest™ as experimental, and therefore, the cost is not reimbursable.
SAGE Oncotest™ Pricing
| Price List | Basic1 | Advanced2 | Premium***3 |
|---|---|---|---|
| SAGE Oncotest™ | $2,400 | $3,600 | $4,800 |
| SAGE Oncotest™ and Follow-Up Survey Participation | $1,800 | $2,700 | $3,600 |
| SAGE Oncotest™ in a Pilot Program and Follow-Up | $1,200 | $1,800 | $2,400 |
| SAGE Oncotest™ for Healthcare Providers and Follow-Up | Costs covered by SAGE | ||
| SAGE Oncotest™ for a limited number of tests for an initial period | Costs covered by SAGE |
Price Reduction Programs
A. Follow-Up Survey Participation After you and your oncologist or other healthcare provider have received the test results, we want to follow-up with you to learn what treatment you received and how well it worked. We will use this information for quality control, validation studies, case reports or other research. If you agree to participate in this follow-up survey, SAGE offers a 25% discount.
B. Pilot Trial with your Healthcare Provider If your healthcare provider (oncologist or your hospital) has a special arrangement with SAGE for a pilot study to evaluate the utility of the SAGE Oncotest™ and you agree to participate in the follow-up survey as described above in section A, SAGE offers a 50% discount.
C. Oncologists other Health Care Providers If you are an oncologist, a physician, another healthcare provider, or are an active patient advocate, and agree to participate in the follow-up survey described in section A, we will waive the entire fee for you.
D. Limited Trial Free of Charge If SAGE has agreed to provide a limited number of complementary SAGE Oncotests™ for your oncologist, the costs of the test might be fully covered.
Included in Pricing
Pricing for the SAGE Oncotest™ includes a) overnight shipping within the USA, b) handling fees of your physician or hospital, c) performing the test, d) reporting the results, and e) if requested, consulting with your treating Oncologist. Pricing for the SAGE Oncotest™ does not include the cost for obtaining the sample.
SAGE requires your voluntary consent to our terms and conditions regarding the use of your tissue specimen and data to provide the best possible results and guidance.
Services
By signing this consent, you confirm that your treating physician has explained the risks and benefits of the SAGE Oncotest™ and that you are requesting a biopsy sample tested by SAGE.
Specimen Terms and Privacy
When SAGE receives your specimen, any tissues created out of your sample and any results of
analyses will become property of SAGE and may be used for any purposes, including quality
assurances, quality control, general research, and tissue banking initiatives. SAGE takes individual privacy seriously, especially when complying with HIPAA regulations. We are committed to protecting the confidentiality of all personal information we collect from you. While adhering to federal and state laws, we may use and retain your personal information for various purposes, including quality control and research; for example, if we want to reach out to you in the future.
Benefits and Risks
Benefits: As explained on the first page, the SAGE Oncotest™ will enable your oncologist to avoid you being treated with a drug that cannot work. Furthermore, you also consent to SAGE’s terms and conditions regarding the use of your data and tissue specimen and are therefore providing you and your healthcare provider with the SAGE Oncotest™ results at a partially or fully discounted rate.
Risks: You acknowledge that SAGE may use of your data and tissue specimen and that it is not associated with a medical risk to you.
Disclaimer of Warranties
Except as expressly stated in this Consent Form, the services being provided by SAGE, including, but not limited to, test results, are furnished “as is,” with all faults and without a warranty of any kind, express or implied, including any warranty of merchantability or fitness for a particular purpose. You agree and acknowledge that SAGE will not be liable to you for any damages of any kind whatsoever, including, but not limited to, indirect, special, incidental, or consequential damages in connection with or related to health outcomes realized by relying on the SAGE
Oncotest™ results.
Terms and Conditions
1. SAGE may use your protected health information (PHI) and your SAGE Oncotest™ results for quality assurance, quality control, general research, commercial, or any other purposes.
2. SAGE may follow up with you or your healthcare provider in the future and use your PHI for further research, e.g., to correlate our test results with the clinical outcome to the therapy you have received.
3. The provided data and tissue specimen will become sole property of SAGE and may be stored indefinitely.
4. Any potential commercial benefit, including, but not limited to, research findings, intellectual property such as trade secrets or patents, will become the sole property of SAGE.
HIPAA Notice & Hold Harmless
HIPAA is the Health Insurance Portability and Accountability Act of 1996. If you communicate via e-mail or consent to receive information by e-mail, you acknowledge that communicating health information via ordinary unencrypted emails has inherent risks, specifically the loss of privacy. Except for a PHI breach directly caused by SAGE, you agree to indemnify and hold SAGE and each of its directors, officers, employees, agents and affiliates, harmless from and against any and all claims, actions, suits, proceedings, losses, damages and expenses (including, without limitation, reasonable attorneys’, Contractors’ and experts’ fees (collectively, “Claims”) arising out of or relating to a PHI breached not directly caused by SAGE.
Voluntary Participation
I acknowledge I have read and understood this document, and voluntarily authorize SAGE to use
my data and tissue specimen for quality assurance, quality control, general research, commercial development, or any other purposes. I may withdraw my consent at any time, by corresponding with SAGE. If I withdraw my consent after SAGE has provided me and my oncologist with the SAGE Oncotest™ results, SAGE will no longer contact me or obtain PHI from my healthcare provider for research purposes, however, SAGE may still use my data and tissue specimen as outlined in the terms and conditions above