Case 1:20-cv-01580-LPS Document 1-8 Filed 11/23/20 Page 1 of 4 PageID #: 439
`Case 1:20-cv-01580-LPS Document 1-8 Filed 11/23/20 Page 1 of 4 PageID #: 439
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`EXHIBIT 8
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`EXHIBIT 8
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`Case 1:20-cv-01580-LPS Document 1-8 Filed 11/23/20 Page 2 of 4 PageID #: 440
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`Foundation Medicine Announces Commercial Launch of Liquid Biopsy
`Assay, FoundationACT™
`
`-- Blood-based Genomic Profiling Assay Provides New Option for Cancer Patients Who
`Are Not Candidates for Tissue Biopsy --
`
`May 03, 2016 04:02 PM Eastern Daylight Time
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`CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ:FMI) today announced 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. 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.
`
`“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.
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`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.
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`Technical Validation Data Confirms Accuracy, Sensitivity of FoundationACT Genomic Profiling Assay
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`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
`Case 1:20-cv-01580-LPS Document 1-8 Filed 11/23/20 Page 3 of 4 PageID #: 441
`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.
`
`About Foundation Medicine
`
`Foundation Medicine (NASDAQ:FMI) is a molecular information company dedicated to a transformation in cancer care in which
`treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer. The
`company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer
`and match them with relevant targeted therapies and clinical trials. Foundation Medicine's molecular information platform aims to
`improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help
`advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or
`follow Foundation Medicine on Twitter (@FoundationATCG).
`
`Cautionary Note Regarding Forward-Looking Statements for Foundation Medicine
`
`This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of
`1995, including, but not limited to, statements regarding the performance of FoundationACT; the ability of FoundationACT to
`identify certain genomic alterations and to overcome the clinical limitations of other liquid biopsy assays; and the benefits of
`comprehensive genomic profiling in cancer care. All such forward-looking statements are based on management's current
`expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ
`materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties
`include the risk that FoundationACT will not identify genomic alterations in the same manner as prior data, that FoundationACT
`will not overcome the clinical limitations presented by other liquid biopsy assays, and the risks described under the caption "Risk
`Factors" in Foundation Medicine's Annual Report on Form 10-K for the year ended December 31, 2015, which is on file with the
`Securities and Exchange Commission, as well as other risks detailed in Foundation Medicine's subsequent filings with the
`Securities and Exchange Commission. All information in this press release is as of the date of the release, and Foundation
`Medicine undertakes no duty to update this information unless required by law.
`
`Foundation Medicine® and FoundationOne® are registered trademarks and FoundationACT is a trademark of Foundation
`Medicine, Inc.
`
`Contacts
`Media Contact:
`Pure Communications, Inc.
`Dan Budwick, 973-271-6085
`dan@purecommunicationsinc.com
`or
`Investor Contact:
`Foundation Medicine, Inc.
`Kimberly Brown, 617-418-2215
`ir@foundationmedicine.com
`
`Tweets by @FoundationATCG
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