Doe, John (A000001)

DOB: 01/01/1960 I Test Number 3

NT@P

Biopsy-F TumoSequencing

T he chart above annotates the percentage or allele frequency, of altered circulating cell-free DNA (% cfDNA) detected in this patient. The detected genomic
alterations are listed in descending oder by % cfDNA by gene.
The FDA Approved in Indication and Available for Use In Other Indications columns describe drugs associated with specific genomic alterations. It is based on
publicly available information as described in the Detailed Therapy Results and Clinical Relevance of Detected Alterations sections of the repo
t Synonymous mutations and Variants of Unknown Significance (VUSs): The functional consequences and clinical significance of these alterations are
unknown and the relevance of therapies targeting these alterations is uncertain. Similar to other genomic alterations detected in circulating cell-free DNA, the
monitoring of these alterations may be reflective of tumor growth, turn-over, size, heterogeneity, vascularization, disease progression, or treatment. This is an
area of clinical investigationthe %cfDNA should be interpreted in context with other clinical criteria and studies.

Definitions
cfDNA Amplification: Amplification was detected for this gene in this patient's circulating cell-free DNA. The Guardant360 test only detects amplification in
certain genes bolded in Table 1. This test does not examine other copy number alterations in other genes. Positive Amplification is present at a level this
observed in the lower 50th percentile of samples with amplificationsStrongly Positive (++): Amplification is psent at a level that is observed in the upper
50th to 9h percentile of samples with amplifications.
Deletion (Del): The Guardant360 test detects short deletions in exons 19 and 20 of the EGFR gene. This test does not examine deletions in other genes.

Comments

None

Results reviewed by: M. Junaid Shabbeer, PhD FACMG

Interpretation
Genomic alterations were detected in the circulating cell-free DNA isolated from this patient s blood specimen. These genomic alterations are cancer-associat
ed somatic variants, some of which have been associated with either increased oreduced clinical response to specific treatments.
All genes listed in Table 1 were analyzed as part of the Guardant360 test and genomic alterations were detected only in the genes listed on the first page
of this report. Genomic alterations were not detected in the other genes listed in Table 1.
Amplification was detected in the circulating cell-free DNA isolated from this patient s blood specimen for the annotated gene(s). The Guardant360 test only
detects amplification in the bolded genes in Table 1 by a1alysis of next-generation sequencing data on circulating cell-free DNA. This test does not examine
other copy number alterations in other genes. This test is not a substitute for other established tissue-based methods that detect gene amplification, for
example, by immunohistochemistry (IHC) or FISH. Unlike tissue-based amplification tests (IHC or FISH), a positive Guardant360 test represents the average
amplification for the interrogated gene across all circulating cell-free DNA present in the patient s blood sample. For example, a positive Guardant360 test
could represent a small population of cells with extremely high levels of the detected gene amplification. Alternatively, it could represent a large population of
cells with low to medium levels of the detected gene amplification. The exact correlation between amplification obtained by the Guardant360 test compared to
IHC or FISH, and how each test differentially guides patient management, is an area of active investigation.

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