Genomic Testing

FOUNDATIONACT®

Our liquid biopsy assay for solid tumors, such as Non-Small Cell Lung Cancer (NSCLC), Breast, Colon, and Prostate. May be considered when tissue is unobtainable, when the physician elects to use a ctDNA assay, or to complement solid tissue testing.
  • Cancer Type
    Solid Tumor
  • Sample Type
    Peripheral Whole Blood
  • Results Expected
    2 weeks*

What is FoundationACT?

FoundationACT is a blood-based circulating tumor DNA (ctDNA) assay for solid tumors that identifies clinically relevant genomic alterations driving the growth of a patient's cancer. This liquid biopsy can help physicians identify treatment options by providing clinically actionable information relevant to diagnosis, risk-stratification, and prognosis. Test results provide information about potential targeted therapies and/or available clinical trials to better inform treatment decisions.

FoundationACT is validated to detect all classes of genomic alterations and to analyze more than 60 of the most commonly mutated genes in solid tumors using only a blood sample.

Overview

FoundationACT

  • >60

    genes interrogated

  • 99%

    PPV†

  • 99%

    sensitivity‡

  1. A single assay that detects all 4 classes of genomic alterations required to comprehensively profile a tumor.
  2. Identification of resistance mutations or fusions in lung cancer§
  3. Can be integrated with solid tissue testing results to give a more complete picture of the evolution of a patient’s tumor
  4. Requires only two 8.5mL tubes of blood
Gene List →

† 99% PPV for all alterations, calculated as a weighted average of the PPV for each class of alteration, with the weighting based upon the frequency with which each class is detected. The PPV for base substitutions, indels, rearrangements, and copy number variations, each independently, are 99.9%, 98.8%, 98.0%, and 97.6%, respectively.


‡ >99% sensitivity for base substitutions, indels, and rearrangements at ≥ 1% MAF. Sensitivity for base substitutions at >0.5% MAF is 98.9% and sensitivity for copy number variations is >95% when the tumor fraction is ≥ 20%.


§ Ou SI, Young L, Schrock AB, Johnson A, Klempner SJ, Zhu VW, Miller VA, Ali SM. Emergence of Preexisting MET Y1230C Mutation as a Resistance Mechanism to Crizotinib in NSCLC with MET Exon 14 Skipping Journal of Thoracic Oncology (2017)

Publications

FoundationACT has been validated to detect all four classes of genomic alterations.

Validation Study Summary

Published Clinical Study

The Analytical Validation of a Hybrid Capture-based Next-generation Sequencing Clinical Assay for Genomic Profiling of Cell-free Circulating Tumor DNA

An assay’s validation offers insight into the quality of its laboratory performance and its ability to confidently detect genomic variants at various frequency levels. In this validation study, 2,666 reference alterations were utilized to evaluate the FoundationACT liquid biopsy assay against multiple orthogonal methods, including matched tissue with FoundationOne®, achieving high sensitivity in detecting genomic alterations even at low mutant allele frequencies (MAF>0.25%) often observed in clinical samples.

View the Published Paper

Published Clinical Study

Hybrid capture-based genomic profiling of circulating tumor DNA from patients with estrogen receptor-positive metastatic breast cancer

Genomic changes that occur in breast cancer during the course of disease have been informed by sequencing of primary and metastatic tumor tissue. For patients with relapsed and metastatic disease, evolution of the breast cancer genome highlights the importance of using a recent sample for genomic profiling to guide clinical decision-making. Obtaining a metastatic tissue biopsy can be challenging, and analysis of circulating tumor DNA (ctDNA) from blood may provide a minimally invasive alternative.

View the Published Paper

Interested in learning more about how a Comprehensive Genomic Profiling test might help your patient? Our publications can help:

View all reports & validation

Order FoundationACT

We provide physicians with several options for ordering FoundationACT for patients including online, fax, and e-mail. Healthcare providers must first complete a test requisition form to start the process and can expect results typically within 2 weeks from the time a specimen is received.

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Providers

FoundationACT can be ordered online, by fax, or by phone. Please review and complete the provider resources before ordering.

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Provider Resources

Patients

FoundationACT is ordered by your healthcare provider. Our patient info kit has all the information you and your doctor need to discuss FoundationACT testing.

Patient Brochure

Patient Resources

Questions? We’re here to help.

Call Foundation Medicine Client Services at (888) 988-3639 between 8:00 am ET and 8:00 pm ET, Monday through Friday. You can also send us an email and a representative will respond during regular business hours.

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We have even more to offer.

Learn more about our other tests, FoundationOne CDx™, FoundationOne®Heme, or explore insights and trials or partnerships.

* Typical turnaround time from receipt of specimen is two weeks