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 FoundationOne® 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 in 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, often missed by other ctDNA assays§
  3. Can be integrated with FoundationOne results to give a more complete picture of the evolution of a patient’s tumor
  4. Requires only two 10mL tubes of blood

>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%.

Publications

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

Validation Study White Paper

Published Clinical Study

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

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

Published Clinical Study

CD74-ROS1 fusion in NSCLC detected by hybrid capture-based tissue genomic profiling and ctDNA assays

A case study of a patient with metastatic NSCLC with a ROS1 fusion detected by tissue and blood hybrid capture–based assays but not by another circulating tumor DNA (ctDNA) assay.

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.

A doctor looking at the camera

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.

Download Patient Brochure

Providers

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

Order Now

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.

Contact Us

We have even more to offer.

* Typical turnaround time from receipt of specimen is two weeks

§ 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)