Informed Consent

 

Test Results, Interpretation, Privacy, Confidentiality & Data Use Terms


Purpose of the Test
The breast cancer test offered by Cantel ™ is designed to support early detection by analyzing biomarkers in your blood. This test is intended to aid healthcare providers but is not a diagnostic tool and should not replace clinical assessments or imaging studies.
Key Information

  • The test results are for screening purposes only and do not confirm or rule out the presence of breast cancer.
  • There is a possibility of false positive or false negative results due to biological variations or other factors.
  • The test may not be suitable during pregnancy or lactation, as hormonal and physiological changes can affect the results.
  • Results must be discussed with your healthcare provider before making medical decisions.

1.  Test Results and Interpretation

  • The results of this test are not a guarantee of the presence or absence of breast cancerand should not be used as the sole basis for diagnosis or to replace standard medical care.
  • Test results may differ from the actual state of the disease due to factors such as tumor heterogeneity, biological variations, and other influences including, but not limited to, inflammatory conditions, medication use, exposure to radiation, or other medical interventions. Additionally, errors such as sample contamination, degradation, or pre-analytical deviations may impact the accuracy of the results.
  • This test is intended to assist, but not replace, the independent clinical judgment of a qualified healthcare professional. Patient care and treatment decisions should always be based on a comprehensive evaluation, including medical history, physical examination, imaging studies, histopathology, and other relevant diagnostic tests.
  • False positive and false negative results are possible and should be considered when interpreting the findings. This test may detect molecular signals associated with very early-stage breast cancer that may not yet be visible through conventional imaging or clinical examination.
  • The information provided by this test should be used and acted upon only by a licensed medical practitioner under applicable laws and regulations. Patients are strongly encouraged to consult with their healthcare provider to discuss the results and determine appropriate next steps.   

                 
2.  Purpose of Data Collection
The personal and medical information provided by the participant is being collected for the sole purpose of facilitating breast cancer screening and the accurate interpretation of test results. The information may also be utilized for associated clinical care, quality assurance, performance evaluation, and research activities, provided such use is conducted in compliance with applicable laws and ethical standards.

3.  Confidentiality of Health Data
All information provided by the participant will be maintained in strict confidence and protected in accordance with applicable laws, regulations, and professional standards governing the use, storage, and disclosure of health information.
Access to the data will be limited to authorized Cantel personnel, healthcare providers involved in the screening process, and certified laboratory staff. The information will not be disclosed to third parties without your explicit consent, except as required by law or for purposes related to clinical care, quality assurance, or approved research activities conducted in compliance with applicable regulations.

4.  Use of Personal and Medical Data
The information collected may be used for the following purposes:

  • To administer and provide breast cancer screening and related diagnostic services;
  • To communicate test results to you and/or your designated healthcare provider;
  • To support de-identified research, clinical outcome assessments, and performance improvement initiatives;
  • To enhance service delivery, ensure quality assurance, and improve participant experience.

No personally identifiable information will be used in any published research or shared with external parties without your explicit, written consent.

5.  Voluntary Participation & Withdrawal
Participation is completely voluntary. You have the right to withdraw from the program at any time without it affecting your access to medical care, test results, or any other services provided by Cantel. If you choose to withdraw, Cantel will cease any further use of your personal and medical data, except where retention is required by law or regulatory obligations. Any such retention will be limited to the extent necessary to comply with applicable requirements.

6.  Media, Testimonials & Research Use (Optional)
From time to time, Cantel may invite participants to share their personal stories, testimonials, or images for use in educational materials, awareness campaigns, and patient advocacy initiatives. Such use of your information will only occur with your separate, explicit, and written consent, and you may decline participation without any impact on your screening or care.
Consent & Agreement

Consent & Agreement

 

Please review the statements below to indicate your agreement:

  • I acknowledge that I have read and understood the above terms.
  • I consent to the collection, storage, and secure use of my personal and medical data for the purposes of breast cancer screening and related clinical care.
  • I understand that I may withdraw my consent at any time without affecting my access to care or services.
  • (Optional) I give permission for Cantel to contact me regarding participation in anonymized research studies or outreach activities that support clinical and public health efforts.


I have read and understood the information provided above. I have had the opportunity to ask questions and discuss any concerns. I voluntarily consent to undergo the blood-based breast cancer test.

Note - This test is not recommended for women as described below:
Exclusion Criteria:

  • Subjects with history of treatment-refractory disease.
  • Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the collection time point.
  • Currently enrolled in an investigational study.
  • Currently on hormone replacement therapy.
  • Previous (or current) chemotherapy or radiotherapy treatment or neo-adjuvant therapy.
  • Pregnant or breast-feeding women.
  • Subjects who had undergone blood transfusion within the past two months.