This assay utilises hybrid capture-based next‑generation sequencing technology to detect all four classes of genomic alterations in >60 cancer-related genes in solid tumours using only a blood sample.6

FoundationACT® has been optimised to achieve the high sensitivity and specificity needed to accurately isolate and characterise circulating tumour DNA (ctDNA),6 which can provide clinically relevant information.22,23

FoundationACT® ctDNA assay

         
         
>60 genes interrogated
Insertions & deletions
Base substitutions
Copy number alterations
Rearrangements

No filter results

    >60 genes interrogated
    Insertions & deletions
    Base substitutions
    Copy number alterations
    Rearrangements

No filter results

How accurate is FoundationACT®?

FoundationACT® has demonstrated accuracy with 99% sensitivity and 99% specificity across all four classes of genomic alterations:

TECHNICAL INFORMATION
BASE SUBSTITUTION9,24
INSERTIONS AND DELETIONS9,24
REARRANGEMENTS9,22
COPY NUMBER ALTERATIONS (CNA)*9,22

MAF/Tumour

Fraction

MAF ≥0.5%

MAF ≥1%

(1-40 BP)

MAF ≥1%
MAF ≥20%
Tumour fraction <20%
Sensitivity >98.9% >99.9% >99.9% Will vary depending on CNA level and tumour fraction
95.3%
Specificity (PPV) >99.9% 98.8% 98.0% 97.6%
Accuracy 100% concordance with orthogonal methods†‡ 

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Technical information

MAF/Tumour

Fraction

Sensitivity
Specificity
Acuracy
Base substitutions⁹ ²⁴
MAF ≥ 0.5%
>98.9%
>99.9%
100% concordance with orthogonal methods†‡ 

Insertions and deletions⁹ ²⁴

(1-40 BP)

MAF ≥ 1%
>99.9%
98.8%
Rearrangements⁹ ²²
MAF ≥ 1%
>99.9%
98.0%
Copy number alterations (CNA)*⁹ ²²
MAF ≥ 2.0%
Tumour Fraction <20%
Will vary
95.3%
97.6%

No filter results

MAF: mutant allele frequency; PPV: positive predictive value.

*Copy number ≥8 genes with at least 4 targets.

Orthogonal methods: FoundationOne®; Digital Droplet PCR and break-point PCR.

In 48 clinical ctDNA samples, including 95 alterations of all classes.

FoundationACT® Publications

Selected publication

Circulating Tumor DNA Identifies EGFR Co-Amplification as a Mechanism of Resistance to Crizotinib in a Patient with Advanced MET-Amplified Lung Adenocarcinoma.

J Thorac Oncol. May 2017.

Selected publication

Emergence of Preexisting METY1230C Mutation as a Resistance Mechanism to Crizotinib in NSCLC with MET Exon 14 Skipping.

J Thorac Oncol. January 2017.

FoundationACT® FAQs

  • DOES THE FOUNDATIONACT® CTDNA ASSAY APPLY TO ALL TYPES OF CANCER?

    FoundationACT® can help deliver meaningful molecular insights across a range of solid tumour types, including but not limited to: Lung,25-28 Breast,29,30 Gastrointestinal31 and Prostate Cancer.32

  • WHO IS ELIGIBLE FOR A FOUNDATIONACT® PROFILE?

    FoundationOne® is our flagship profile for patients with solid tumours. However, in cases where Comprehensive Genomic Profiling (CGP) with FoundationOne® is not possible or feasible, the patient may be eligible for profiling with FoundationACT®.

  • WHEN MAY FOUNDATIONACT® BE USED IN PLACE OF FOUNDATIONONE®?

    FoundationACT® is an alternative profiling method to FoundationOne® in cases where there is insufficient or inadequate tissue from a recent biopsy,23 or where repeat analyses have led to tissue exhaustion precluding subsequent testing.33 

     

    In other instances, procedural limitations can be the prohibiting factor, such as when direct biopsy is technically difficult to obtain,23 or when progression or recurrence is suspected and a repeat biopsy is not feasible.33 

     

    Sometimes patient factors can determine the need for profiling with FoundationACT®, for example, if tissue biopsy poses an unacceptable risk to the patient,22,23 or the patient refuses a tissue biopsy.

  • WHAT IS CIRCULATING TUMOUR DNA (ctDNA) AND WHY IS IT USEFUL?

    In a cancer patient, tumour cells that undergo apoptosis or necrosis also shed cell-free DNA (cfDNA).23,33,34  The cfDNA that is shed from tumour cells into the circulation is known as circulating tumour DNA or ctDNA.35 By analysing cfDNA isolated from a patient’s blood, we can now identify clinically relevant genomic alterations in ctDNA, which may have prognostic and therapeutic value.22,23 As such, ctDNA is increasingly being recognised as an important cancer indicator of genetic information.23

  • IS CIRCULATING TUMOUR (ctDNA) DIFFICULT TO DETECT?

    Detecting ctDNA can be challenging.23, 36 Circulating cell-free DNA (cfDNA) is highly fragmented, present at very low concentrations, and contains only a small fraction of tumour-derived ctDNA (often <1.0% of total cfDNA).22,33,35,36 Not all tumours shed DNA into blood stream, so ctDNA may not be detected in all patients. The level of ctDNA is also known to vary considerably (between 0.01% to 90%),33,37 depending on tumour type, tumour stage, and a range of other factors, including rate of release, physiological factors (e.g. renal function) and time of blood draw.22,33,37-42

     

    As a result, the isolation and identification of ctDNA require ultrasensitive analytical analysis.22,36

How to order a FoundationACT® profile

Patients with solid tumours can be profiled with our liquid biopsy, FoundationACT®, which requires two tubes of peripheral whole blood.

The average turn-around time for a FoundationACT® profile is 14 days from the date Foundation Medicine, Inc. laboratory in Boston receives the blood sample.

When submitting specimens to Foundation Medicine, please include the following items in the FoundationACT® Specimen Kit:

Appropriate specimen per the FoundationACT®
Specimen Guidelines

Completed Requisition Form

Copy of recent pathology/cytology reports

We have even more to offer - learn about our other profiles: