Together, we can transform the future of cancer care.
Tracking early stage breast cancer with ultrasensitive ctDNA
Information for patients with breast cancer
Monitoring therapy response with ultrasensitive ctDNA across cancer types
Ultrasensitive ctDNA detection in early-stage lung cancer
Personalis is transforming the development of next-generation therapies.
Please review this information carefully and discuss it with your patient or patient’s legal guardian. Please note that samples collected in New York State are ineligible for NeXT Personal Dx testing at this time. NeXT Personal Dx tests are performed by the Personalis Clinical Laboratory, Personalis, Inc. (“Personalis”).
The NeXT Personal Dx test is a personalized tumor-informed liquid biopsy assay designed to detect molecular residual disease (MRD) using circulating tumor DNA (ctDNA) from patients previously diagnosed with a solid tumor cancer. Individualized molecular profiles are established by upfront tissue and matched normal whole genome sequencing (WGS). The assay tracks up to 1800 somatic variants in a personalized patient panel. After testing is complete, a detailed written report in English, will be sent to the ordering healthcare provider(s) for their review.
No test is 100% accurate. Personalis takes steps to reduce the risk of errors, but there are technical and biological limitations to the test. Thus, there is always a small chance of an inaccurate result that could potentially affect the decisions made by the patient, patient’s family, or ordering healthcare provider(s). The accuracy of NeXT Personal Dx test results may be affected by the quality of samples provided. If, for example, samples are contaminated, mislabeled, or have other problems when they are sent to Personalis, the samples may not be usable for the NeXT Personal Dx test or the results of the test may not be accurate. The results of the NeXT Personal Dx test become part of a patient’s medical record. Patients or their legal guardians must understand and agree to assign all applicable health insurance benefits and/or insurance reimbursement they have under their health plan(s) to Personalis for services performed by Personalis. They must also agree to appoint Personalis as their authorized representative and convey to Personalis, to the full extent permissible under the law, the power to: (1) file medical claims with the health plan(s); (2) file appeals and grievances with the health plan(s) and/or any agency or governmental body with applicable authority; (3) obtain and release medical records and insurance information as necessary to process a claim, appeal or grievance; and (4) collect payment of any and all medical benefits and insurance proceeds (including Medicare and Medicaid). Such appointment and conveyance must include all the patient’s rights in connection with any claim, right, or cause of action including litigation against the health plan(s) that they may have, including the right to claim on patient’s behalf all such benefits, claims, or reimbursement, and to seek any other applicable remedy, including fines.
The chance of a false positive or false negative result, due to laboratory errors incurred during any phase of the testing (pre-analytical, analytical, or post-analytical), cannot be excluded. The manner in which the services generate results, reports, and other information is complex, dependent upon operator accuracy, pre- and post-analytical factors, and the possibility of software or other error cannot be eliminated. Personalis does not provide any express or implied warranty as to the accuracy of results provided, or the outcomes from their use. Referral to counseling should be considered if appropriate. Learning about the genetic information obtained from this test and the implications for the patient and the patient’s cancer treatment may cause emotional or psychological stress.
Legal guardians who consent for testing of a minor should understand that incidental findings may be detected that may not be related to the patient’s current diagnosis and may identify risk for other adult-onset diseases, which could also have implications for other family members. Minors of sufficient maturity should be given the opportunity to assent for testing.
Patients or their legal guardians have the right to refuse this test. If they decide not to take this test, they should discuss other testing and/or treatment options with their healthcare provider.
The patient’s individually identifiable health information obtained in connection with the Personalis NeXT Personal Dx test will be maintained, used and disclosed by Personalis in accordance with applicable law. In addition, Personalis may remove personal identifiers in accordance with applicable law (such as the patient’s name, address, or birth date) from the test information so that the patient cannot be identified based on standards set forth in applicable law. The resulting information is called de-identified information. This de-identified information may be retained by Personalis and can be used for research and development work that may help Personalis improve its tests, and may be published in scientific and medical journals and conferences. Personalis may also work with outside third parties, providing them access to this de-identified information. If researchers discover something from a patient’s de-identified information (for example, a genetic change that increases the patient’s risk for developing other types of cancers) the patient will not be re-contacted by Personalis or other researchers with access to the database.
Patients or their legal guardians may decide to revoke or withdraw their consent at any time. If a patient or the patient’s legal guardian decides to withdraw consent, any further testing and processing of the patient’s sample(s) will not proceed. However, withdrawal of consent will not have any effect on any testing, processing, or other use or sharing of the patient’s sample(s) that has already occurred, on any anonymized or de-identified test results or associated data (including whole-exome and transcriptome analysis data), or any anonymized or de-identified materials extracted or derived from the patient’s sample, such as DNA and RNA, for which the patient provided consent for Personalis to retain. To revoke a patient’s consent, the patient or legal guardian, or the ordering healthcare provider(s), must submit a written request to 6600 Dumbarton Cir Fremont, CA 94555, attention: Privacy Officer.
My signature constitutes a Certificate of Medical Necessity and certifies that I am the patient’s health care provider. I have explained to the patient or the patient’s authorized representative (either hereafter called “the patient”), the nature and purpose of the testing to be performed, discussed the risks and benefits of the testing, and offered alternatives to such testing. At a minimum, I have provided the patient with the information provided to me at personalis.com/consent or within the Personalis Consent Card. I have obtained informed consent, that is signed, dated, and in writing to the extent legally required, from the patient, in accordance with applicable law, to permit Personalis, Inc. to (a) perform the testing specified herein, no other tests (b) release the test results to me or my organization as the ordering provider and patient’s treating clinician; (c) release the test results to the patient’s third-party payer as needed for reimbursement purposes, (d) retain test results and associated data (including genetic data such as whole-genome, whole-exome and/or transcriptome analysis data) and any materials extracted or derived from the patient’s sample(s), such as DNA and RNA, for an indefinite period for internal quality assurance and/or other operations purposes (including after any revocation of the patient’s consent to the extent permitted under applicable law), and (e) anonymize or de-identify the test results and associated data (including genetic data such as whole-genome, whole-exome and transcriptome analysis data) and any materials extracted or derived from the patient’s sample(s), such as DNA and RNA, and use and disclose such anonymized or de-identified test results, associated data, and material for future unspecified research or other purposes (including after any revocation of the patient’s consent to the extent permitted under applicable law).If written consent is legally required, I will maintain a copy of the written consent and make it available to Personalis, Inc. upon reasonable request.
