On May 3, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) reported the launch of FoundationACT (Assay for Circulating Tumor DNA), an analytically validated and accurate blood-based circulating tumor DNA (ctDNA) assay that provides patients and oncologists with a new option for comprehensive genomic profiling when a tissue biopsy is not feasible or when tissue is not available (Press release, Foundation Medicine, MAY 3, 2016, View Source [SID:1234511842]). By analyzing circulating tumor DNA isolated from a patient’s blood, FoundationACT can identify clinically relevant genomic alterations, and like Foundation Medicine’s tissue-based genomic profiles, FoundationOne and FoundationOne Heme, FoundationACT delivers this comprehensive molecular information in a concise report that matches the findings with potentially relevant targeted therapies and clinical trials.
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"Our goal has always been to deliver a highly accurate and sensitive assay available for blood based samples, and the confirmatory data produced by our clinical collaborators indicates that we have succeeded in achieving that with the release of FoundationACT," said Vincent Miller, M.D., chief medical officer of Foundation Medicine. "Bringing the rigor used to develop and validate FoundationOne to this assay, we believe we have overcome many of the clinical limitations presented by other tests in the liquid biopsy field. Launching FoundationACT strengthens our market leading position as the go-to resource for a complete, end-to-end offering of comprehensive molecular information solutions."
The presence of ctDNA, which is DNA shed from tumors that circulates in blood, is a well-established phenomenon that has led to the development of non-invasive tumor sequencing assays. However, the concentration of ctDNA compared to other DNA fragments derived from other tissue sources can vary significantly depending on tumor type and disease stage. For many cancer patients, this means that the proportion of detectable tumor DNA in the blood is extremely low, making the detection of therapeutically relevant genomic alterations much more difficult and error prone as compared to tissue-based approaches.
FoundationACT, which was launched to Foundation Medicine’s pharmaceutical partners for research use in December 2015, interrogates all clinically relevant alterations across 62 genes and fusions across six genes, and it has been optimized for sensitivity and specificity of all classes of molecular alterations, including base substitutions, insertions and deletion, focal amplifications and gene fusions. The assay was developed for patients who are not candidates for comprehensive genomic profiling with FoundationOne. Factors that may preclude patients from undergoing FoundationOne testing include insufficient or inadequate tissue from a recent biopsy, safety risks associated with biopsy, or medical contraindications to re-biopsy. In July 2015, Foundation Medicine initiated a large-scale, multi-center prospective clinical study to clinically validate FoundationACT across various cancers and stages of the disease. A portion of the patients in the study will include those with earlier-stage disease, allowing the company to investigate how different tumor types shed DNA into the bloodstream at different stages of the disease.
Technical Validation Data Confirms Accuracy, Sensitivity of FoundationACT Genomic Profiling Assay
At the Annual Meeting of the Advances in Genome Biology and Technology (AGBT) in February 2016, Foundation Medicine reported data from its analytic validation study in a presentation titled, "Assessment of the Relative Clinical Utility of ctDNA and Tissue Biopsies for the Detection of Actionable Genomic Alterations in Routine Clinical Oncology Specimens." Study highlights demonstrated that FoundationACT results were 100 percent concordant with FoundationOne and droplet digital PCR (ddPCR) results across 87 base substitutions (43 at < 5% MAF), three indels and five genomic alterations.
At the American Association of Cancer Research Annual Meeting in April 2016, Foundation Medicine further reported analytical validation data in a poster presentation titled, "Rigorous Validation of a Clinical Circulating Tumor DNA Assay for Cancer Molecular Profiling." As part of this study, results compared alterations from patient-matched ctDNA and FFPE biopsies across more than 200 samples from lung, breast and other cancers. This rigorous analytic validation study demonstrated ≥99 percent sensitivity in the detection of alterations present in blood at low frequency with a very low rate of false positives, realizing the potential of ctDNA-based molecular profiling for the management of patients with cancer. In 48 clinical ctDNA samples, 95 alterations of all classes were 100 percent confirmed by orthogonal testing.