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Our FDA-approved liquid biopsy comprehensive genomic profiling service offers a minimally-invasive option, alternative or complementary to FoundationOne®Liquid CDx, for all patients with solid tumours at optimal times beneficial to their treatment
journey1-3

<2 weeks FDASingle blood draw Quick and convenient single blood draw(2 x 8.5 mL whole blood) helps avoid invasive biopsies and enables faster treatment decisions1,12–16 >300 genes, MSI, bTMB, Tumour Fraction Assesses all four main classes of genomic alterations* in >300† cancer-related genes plus MSI, bTMB and Tumour Fraction1,2,4–11FDA-approved Based on our analytically and clinically validated, FDA-approved comprehensive genomic profiling platform and bioinformatics workflow§1–3,17,18 Reflex testingOption of reflex testing to FoundationOne CDx if no actionable genomic alterations are detected in the liquid biopsy sample1,15,18
Genes and genomic signatures

FoundationOne Liquid CDx reports >300 genes and is able to detect both novel and known variants, including four classes of genomic alterations (base substitutions, insertions or deletions, copy number alterations and gene rearrangements), genomic signatures (MSl, bTMB) and Tumour Fraction, to provide prognostic, diagnostic and predictive insights that inform research or treatment decisions for individual patients across all solid tumours.‡1,2

Base SubstitutionsInsertions and deletionsCopy number alterationsRearrangementsMicrosatellite InstabilityMSIbTMBAnalyses>300known cancer-relevant genes%

Assesses all four main classes of genomic alterations* in >300 cancer-related genes, including guideline-recommended genomic alterations associated with available targeted therapies in all solid tumours.1·2.4-11

The FDA-approved liquid biopsy service that reports both MSl and bTMB, pan-tumour genomic signatures that may help inform eligibility for immunotherapy.1-3,19-27

High sensitivity and specificity¥ for key genomic alterations, MSI and bTMB across all solid tumours.1,2

Reports Tumour Fraction, the percentage of tumour-derived circulating cell-free DNA, as a measure of the likelihood of detecting genomic alterations in the liquid biopsy sample.1,2

Faster treatment decisions

Quick and convenient single blood draw helps avoid invasive biopsies and enables faster treatment decisions1,28

FoundationOne Liquid CDx requires only two tubes of b lood from a single blood draw (2 x 8.5 ml whole blood) and has a turnaround time of less than 2 weeks from receipt of the sample at our laboratory to report, thereby allowing informed treatment decisions to be made faster.1-28

This may help reduce distress that patients may experience from long waiting times for scheduling a biopsy and receiving the results associated with tissue-based testing.12-15

Potential gain in time to treatment decisionTypical timelines associated with liquid- versus tissue-based CGPLIQUIDTISSUE7 d14 d21 dSample collection and preparation, including biopsy waiting time and shipment28 d35 d

FoundationOne Liquid CDx may also help reduce requirements for healthcare infrastructure and resources compared with tissue-based testing.29
Validation

Based on extensively validated comprehensive platform3,17,18

Like FoundationOne CDx, FoundationOne Liquid CDx is based on an analytically and clinically validated, comprehensive platform and bioinformatics workflow¶1-3,17,18,30
Analytical validationClinical validationBioinformaticsReview and approval of the FoundationOne Liquid CDx platform workflow by the FDA

What is the difference between analytical and clinical validation?

RFMI_F1LCDx launch_Blueprint EU_image 10 editable version Clinically validated to identify specific alterations and approved therapies,e.g. to identify patients for whom EGFR TKIs are indicated 1,3 Ability to divide one population into two or more groups on the basis of outcomes,such as treatment response 26,27 Analytically validated to identify alterations across the entire coding region of EGFR 1,3 Ability to detect and measure the presence of a biomarker of interest accurately, reproducibly and reliably 26,27 Example forFoundationOneCDx for EGFR genein NSCLC What doesit mean? Clinical validation Analytical validation
Clinical use in solid cancers

FoundationOne Liquid CDx is suited for all solid tumours including NSCLC, breast cancer, ovarian cancer and prostate cancer1,2,4-11

FoundationOne Liquid CDx covers guideline-recommended, and other clinically relevant genomic alterations and signatures for NSCLC, breast, ovarian and prostate cancer.1,2,4-11,19-25,33-38
EGFRTMBNSCLCBREASTOVARIANPROSTATEBRAFALKROS1HER2 (ERBB2)RETMETNTRK1/2/3MSIESR1NTRK1/2/3BRCA1BRCA2HER2 (ERBB2)PIK3CAMSIBRCA1BRCA2ATMCHEK2MSH2/6PALB2MLH1PMS2RAD51DCDK12FANCAMSIBRCA1BRCA2RAD51BRIP1PALB2MSH2/6PMS2MSIBRCA1

FoundationOne Liquid CDx has demonstrated strong clinical utility

Our previous blood-based comprehensive genomic test demonstrated clinical utility for treatment selection at diagnosis in metastatic NSCLC in BFAST (Blood First Assay Screening Trial), a global, prospective cohort study.30-39
ALK+ prevalenceThe proportion of patients identified as ALK+ using blood-based testing (BFAST) was comparable to that previously reported using tissue-based testing (meta-analysis, range among Western populations)30,40LIQUID5.4%4.5%–6.4%TISSUE

BFAST used an earlier version of Foundation Medicine's current liquid biopsy service, FoundationOne Liquid CDx. The assay used in BFAST for measuring o f ALK+ has been incorporated into FoundationOne Liquid CDx. For concordance results between these two tests, please see our ful l intended use at: www.foundationmedicine.com/F1LCDx.
ctDNA

Sequences circulating cell-free DNA (cfDNA)

FoundationOne Liquid CDx sequences circulating cell-free DNA, which can originate from the primary as well as metastatictumour sites, thereby capturing the disease heterogeneity across the body as the disease evolves.1,2,14,15
Tumour tissueHealthy tissueApoptosisApoptosis Necrosis secretionMain source of cell-free DNA
In-depth report

A clear, in-depth report provides insights on your patient's genomic profile as well as associated targeted therapies, immunotherapies and relevant clinical trials1,2.4-11,41

Approved targeted therapies and immunotherapies for the patient's genomic alterations and biomarkers are ranked alphabetically within NCCN Categories of Preference (for additional information on the NCCN therapy categories please refer to the NCCN Compendium® at www.nccn.org). Reports vary according to regional differences, e.g. EU reports list EU-approved therapy options to support clinical decision-making.‖41

When using different Foundation Medicine services across the patient journey, consistency of the reports aid comparison of the results.41,42

RFMI_F1LCDx launch_Blueprint EU_image 21 version editable Patient and specimen details Summary of all identified gene alterationsand genomic signatures as well as the number of therapy and clinical trial options Gene alterations, clinically relevant targeted therapies and clinical trials for each alteration, to help guide your treatment strategy bTMB and MSI status to help inform eligibility for immunotherapies Therapies ranked alphabetically within NCCN therapy categories** Tumour Fraction, the percentage of tumour-derived DNAin the liquid biopsy sample, providing you with a measure of the likelihood of detecting genomic alterations in the liquid biopsy sample Gene alterations associated with no reportable therapeutic or clinical options Variant allele frequency percentage (VAF%) for base substitutions and insertions and deletions (indels) 7 1 2 3 4 5 6 ORD-XXXXXXX-XX ORDERED TEST # FR COUNTRY CODE REPORT DATE Lung adenocarcinoma TUMOR TYPE 999999999, FR PATIENT FoundationOne®Liquid CDx is a next generation sequencing (NGS) assay that identies clinically relevant genomic alterations in circulating cell-free DNA. ABOUT THE TEST Lung adenocarcinoma DISEASE 999999999, FR NAME Not Given DATE OF BIRTH Not Given SEX Not Given MEDICAL RECORD # PATIENT Not Given ORDERING PHYSICIAN Not Given MEDICAL FACILITY Not Given ADDITIONAL RECIPIENT Not Given MEDICAL FACILITY ID Not Given PATHOLOGIST Not Given SPECIMEN ID Blood SPECIMEN TYPE Not Given DATE OF COLLECTION Not Given SPECIMEN RECEIVED PHYSICIAN SPECIMEN 0.20% exon 19 deletion (L747_A750>P) EGFR 5 Muts/Mb 1 Afatinib 1 Erlotinib 1 Dacomitinib 1 Gefitinib 1 Osimertinib see p. 11 10 Trials THERAPY AND CLINICAL TRIAL IMPLICATIONS GENOMIC SIGNATURES Blood Tumor Mutational Burden - THERAPIES APPROVED IN THE EU (IN OTHER TUMOR TYPE) THERAPIES APPROVED IN THE EU (IN PATIENT'S TUMOR TYPE) GENE ALTERATIONS No therapies or clinical trials. see Genomic Signatures section Unable to determine Microsatellite status due to insufficient evidence of genomic instability. Tumor fraction is an estimate of the percentage of circulating-tumor DNA (ctDNA) present in a cell-free DNA (cfDNA) sample based on observed aneuploid instability. Cannot Be Determined Microsatellite status 13% Tumor Fraction EGFR exon 19 deletion (L747_A750>P) TP53 R267P For a complete list of the genes assayed, please refer to the Appendix. Gene Alterations Genomic Signatures Cannot Be Determined Microsatellite status 5 Muts/Mb Blood Tumor Mutational Burden 13% Tumor Fraction NCCN Category Clinical Trials 10 Therapies with Lack of Response 0 Therapies Approved in the EU 5 Electronically Signed by Julia A. Elvin, M.D., Ph.D. • 01 June 2020 Julia Elvin, M.D., Ph.D., Laboratory Director CLIA: 22D2027531 Shakti Ramkissoon, M.D., Ph.D., M. M. Sc, Laboratory Director CLIA: 34D2044309 Foundation Medicine, Inc. • 1-888-988-3639 Sample Preparation: 150 Second St., 1st Floor, Cambridge, MA 02141 • CLIA: 22D2027531 Sample Analysis: 150 Second St., 1st Floor, Cambridge, MA 02141 • CLIA: 22D2027531 Post-Sequencing Analysis: 150 Second St., 1st Floor. Cambridge, MA 02141 • CLIA: 22D2027531 of PAGE ORD-XXXXXXX-XX ORDERED TEST # REPORT DATE Lung adenocarcinoma TUMOR TYPE 999999999, FR PATIENT p. 5 GE NE A L TERATIONS WITH NO REPORTABLE THERAPEUTIC OR CLINICAL TRIALS OPTIONS For more information regarding biological and clinical signicance, i ncluding prognostic, dia gnostic, g ermline, a nd potential chemosensitivi implications, s ee the Gene Alterations section. T P 53 C242G NOT E Genomic alterations detected may be associated with activity of certain approved therapies; however, the therapies listed in this report may have varied clinical evidence in the patients tumor type. Therapies and the clinical trials listed in this report may not be complete and/or exhaustive. Neither the therapies nor the trials identified are ranked in order of potential or predicted efficacy for this patient, nor are they ranked in order of level of evidence for this patients tumor type. This report should be regarded and used as a supplementary source of information and not as the single basis for the making of a therapy decision. All treatment decisions remain the full and final responsibility of the treating physician and physicians should refer to approved prescribing information for all therapies. Therapies contained in this report may have been approved through a centralized EU procedure or a national procedure in an EU Member State. Therapies, including but not limited to the following, have been approved nationally in some EU Member States but may not be available in your Member State: Tretinoin, Anastrozole, Bicalutamide, Cyproterone, Exemestane, Flutamide, Goserelin, Letrozole, Leuprorelin, and Triptorelin. The Summary of Product Characteristics of EU approved therapies are available at https: / /www.ema.europa.eu/en/medicines. The information available on EMA's website is updated in regular intervals but may not reflect the current status at any time. In the appropriate clinical context, germline testing of APC, BRCA1, BRCA2, BRIP1, MEN1, MLH1, MSH2, MSH6, MUTYH, NF2, PALB2, PMS2, PTEN, RAD51C, RAD51D, RB1, RET, SDHA, SDHB, SDHC, SDHD, SMAD4, STK11, TGFBR2, TP53, TSC1, TSC2, VHL, and WT1 is recommended. 1 2 4 5 6 8 7 Not Detected Blood Tumor Mutational Burden Microsatellite status Tumor Fraction exon 19 deletion (L747_A750>P) EGFR 0.20% Cannot Be Determined 13.0% FoundationOne® Liquid CDx 1 June 2020 O R D-XXXXXXX-XX 5 Muts/Mb HISTORIC PATIENT FINDINGS 1% increments 0.5% increments C242G TP53 0.10% ORD-XXXXXXX-XX ORDERED TEST # REPORT DATE Lung adenocarcinoma TUMOR TYPE 999999999, FR PATIENT This comparison table refers only to genes and biomarkers assayed by prior FoundationOne®Liquid CDx, FoundationOne®Liquid, FoundationOne®, or FoundationOne®CDx tests. Up to five previous tests may be shown. For some genes in FoundationOne Liquid CDx, only select exons are assayed. Therefore, an alteration found by a previous test may not have been confirmed despite overlapping gene lists. Please refer to the Appendix for the complete list of genes and exons assayed. The gene and biomarker list will be updated periodically to reflect new knowledge about cancer biology. As new scientific information becomes available, alterations that had previously been listed as Variants of Unknown Significance (VUS) may become reportable. Tissue Tumor Mutational Burden (TMB) and blood TMB (bTMB) are estimated from the number of synonymous and non-synonymous single-nucleotide variants (SNVs) and insertions and deletions (indels) per area of coding genome sampled, after the removal of known and likely oncogenic driver events and germline SNPs. Tissue TMB is calculated based on variants with an allele frequency of ! 5%, and bTMB is calculated based on variants with an allele frequency of ! 0.5%. Not Tested = not baited, not reported on test, or test preceded addition of biomarker or gene Not Detected = baited but not detected on test Detected = present ( = Cannot Be Determined = Sample is not of sufficient data quality to confidently determine biomarker status NOTE Electronically Signed by Julia A. Elvin, M.D., Ph.D. • 01 June 2020 Julia Elvin, M.D., Ph.D., Laboratory Director CLIA: 22D2027531 Shakti Ramkissoon, M.D., Ph.D., M. M. Sc, Laboratory Director CLIA: 34D2044309 Foundation Medicine, Inc. • 1-888-988-3639 Sample Preparation: 150 Second St., 1st Floor, Cambridge, MA 02141 • CLIA: 22D2027531 Sample Analysis: 150 Second St., 1st Floor, Cambridge, MA 02141 • CLIA: 22D2027531 Post-Sequencing Analysis: 150 Second St., 1st Floor. Cambridge, MA 02141 • CLIA: 22D2027531 of PAGE 8

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*Base substitutions, insertions or deletions, copy number alterations and gene rearrangements.

†309 genes with complete coding exonic coverage, 15 genes with select intronic or non-coding regions only.

‡Foundation0ne Liquid CDx reports MSI-H status

§Validation based on overall >7,500 samples covering >30,000 unique variants across >300 genes and 37 cancer indications.1,2 To learn more about the clinical and analytical validation of FoundationOne Liquid CDx, click here.

¥75 genes are baited with enhanced sensitivity for all variant types (selected based on increased actionability with current or future targeted therapies; for more information of these 75 genes, please refer to our full gene list): other genomic regions are baited with high sensitivity.

¶Clinical validation based on evidence gathered using an earlier version of Foundation Medicine's current liquid biopsy service, FoundationOne Liquid CDx. For concordance results between these two tests, please see our full intended use at www.foundationmedicine.com/F1LCDx.

‡Therapies contained in the EU version of the report may have been approved through a centralised EU procedure or a national procedure in an EU Member State.

**For additional information on the NCCN categories please refer to the NCCN Compendium® (www.nccn.org).

bTMB, blood Tumour Mutational Burden; cfDNA, circulating cell-free DNA; CGP, comprehensive genomic profiling; ctDNA, cell-free tumour DNA; d, days; FDA, US Food and Drug Administration; MSI, Microsatellite Instability; NCCN, National Comprehensive Cancer Network; NGS, next generation sequencing; NSCLC, non-small cell lung cancer.

References
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