Thank you for your submission!

Please contact BostonGene Client Services with any questions.

BostonGene Client Services
Phone: (781) 552-3131 8:00am–6:00pm ET (Monday–Friday)
Fax: (857) 557-6273

Informed Consent Form for BostonGene Tumor Portrait™ testing

Consent to disclosure of genetic and related medical information and tissue specimens for the performance of the BostonGene Tumor Portrait™ test

The BostonGene Tumor Portrait™ test uses whole exome sequencing (WES) and transcriptome sequencing (RNA sequencing or RNA-seq) to detect genomic alterations such as single nucleotide variants (SNV), insertions/deletions (indels), copy number alterations (CNA), tumor mutational burden (TMB), microsatellite instability (MSI), fusions, frameshifts, rearrangements and expression levels of more than 20,000 genes. The BostonGene report integrates genomic and transcriptomic analyses and, in concert with the patient’s medical history, provides information regarding the likely benefits of therapies or therapeutic combinations, suitable NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) treatment recommendations and ongoing clinical trials.

The process of DNA and RNA sequencing is not 100% error free. The analysis of nucleic acids by next-generation sequencing (NGS) can be affected by multiple factors and may be influenced by specimen collection and storage processes. The lack of detection of a genomic alteration does not definitively rule out that the patient does not carry this genomic variation. Detection of an alteration does not necessarily indicate pharmacologic effectiveness (or lack thereof) of any therapeutic or therapeutic regimen. The BostonGene Tumor Portrait™ test is a CLIA-certified laboratory developed test (LDT) that is not subject to review by the FDA and does not make any definitive treatment recommendations. Decisions regarding your care and treatment, including selection of therapies, are solely based on the independent medical judgment of your doctor. If you have any questions or need additional information, please consult your doctor before signing.

By signing below you consent to the transfer of your tissue samples and the disclosure of your protected health information (“PHI”) for treatment purposes to BostonGene for BostonGene Tumor Portrait™ testing. Submitting your sample for testing is voluntary and you may choose not to have your sample tested. Your personal information will be stored and protected in compliance with applicable U.S. and state laws. There are state and federal laws that prohibit discrimination against individuals for the purpose of employment or obtaining health insurance and prohibit insurers and employers from seeking an individual’s genetic information without consent. However, it is your responsibility to consider the possible impact of genetic test results as they relate to insurance rates and obtaining disability or life insurance and employment. The federal Genetic Information Nondiscrimination Act (GINA) provides some protections against genetic discrimination.

Use and retention of de-identified leftover specimens results and clinical information for research purposes1

BostonGene may remove personally-identifiable information from your test results specimens and clinical information in accordance with applicable law and use and store it indefinitely for de-identified research and development purposes. Although the results of research involving your de-identified test results, specimens and clinical information may be patentable or have commercial value, you will have no legal or financial interest in any commercial development resulting from the research. You may withdraw your consent to use your test results, specimens and clinical information for research purposes and/or request the destruction of your specimens or deletion of your information at any time, with the understanding that, to the extent such sample or information has already been de-identified or used, it cannot be destroyed or retrieved. You may request destruction of your specimens or deletion of your information by sending an email to If you do not want to allow your de-identified sample or information to be used or stored for research, please check the box at the bottom of this form. Checking the box will not adversely affect your medical care or results.

Genomic sequencing secondary findings2

The use of your genomic information may reveal one or more findings not related to the reason for the test known as secondary findings. Many secondary findings are not related to cancer. BostonGene will not report secondary findings not related to cancer if you opt out and check the box below. If you consent, you may receive information beneficial to you or your family, although you may also receive information regarding your or your family’s risk for certain diseases and conditions. Some secondary findings are related to cancer. BostonGene will, therefore, provide secondary findings related to cancer even if you do not opt in and consent to receive secondary findings because they may describe your or your family’s risk for certain cancers and may be beneficial for you and your family. BostonGene strongly recommends that you receive additional consultation from your doctor or a genetic counselor regarding any secondary results you receive because secondary results are not related to the reason that the ordering physician authorized this test. For a list of medical geneticists and counselors who may be available in your area, please visit the National Society of Genetic Counselors website at

Future contact3

Your healthcare provider or BostonGene may also contact you regarding ongoing research, including findings specific to your disease or genomic data, as well as to obtain information regarding your future medical care.

By signing below* you confirm that you have read this consent form, that your physician has reviewed with you the purpose, benefits, and limitations of genomic/transcriptomic testing, and that, unless indicated otherwise below, you consent to a) the release of your specimens and clinical information to BostonGene for the BostonGene Tumor Portrait™ test, b) the retention and use of your de-identified specimens, test results, and clinical information for as long as deemed useful for research and development purposes, which may be indefinite, c) to receive secondary findings, and d) future contact regarding ongoing research.

*Minnesota residents only: by signing below you consent to the retention of your de-identified samples, DNA/RNA and genetic/clinical information for up to 30 years unless you indicate otherwise above.
Alaska, Delaware, Nevada, New Mexico, and New York residents only: by signing below you consent to the retention of your de-identified samples, DNA/RNA and genetic/clinical information unless you indicate otherwise above, in which case your samples will be destroyed within 60 days after collection or upon completion of the genetic tests for which they were collected. By signing below you also consent to future contact unless you indicate otherwise above.

Printed name*



Created with Perfect Survey

Please sign below*

*required field