Case 1:20-cv-01644-RGA Document 1-59 Filed 12/03/20 Page 1 of 3 PageID #: 1363
`Case 1:20-cv-01644-RGA Document 1-59 Filed 12/03/20 Page 1 of 3 PageID #: 1363
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`EXHIBIT 59
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`EXHIBIT 5 9
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`Case 1:20-cv-01644-RGA Document 1-59 Filed 12/03/20 Page 2 of 3 PageID #: 1364
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`Frederick National Laboratory Partners with Illumina for Clinical
`Validation of Liquid Biopsies
`
`Published: 5/30/2019
`
`FREDERICK, Md. – Tissue biopsies are currently the norm for detecting and obtaining information
`about cancer. But this type of biopsy can be invasive, and not every patient can have one performed
`due to the location of their tumor or other health factors.
`
`In recent years, scientists have begun to explore measuring cancer mutations in the blood with liquid
`biopsies. Liquid biopsies are thought to have many advantages over tumor biopsies. These include
`the possibility to detect cancer early through a simple blood test, the ability to identify resistance to
`therapy before it can be seen by a radiographic scan, and the possibility of predicting patient
`response within only a short few weeks after treatment initiation by tracking early changes in tumor
`DNA levels in the blood. Liquid biopsy tests are based on the detection of what is known as
`circulating tumor DNA (ctDNA), which originates from dying tumor cells that spill their DNA into the
`peripheral blood.
`
`However, liquid biopsy research is still in its early stages, and as such, it requires validation to demonstrate its clinical effectiveness. Through a new collaboration with Illumina,
`the Molecular Characterization Laboratory (MoCha) at the Frederick National Laboratory for Cancer Research is working to address this critical need.
`
`The multi-year collaboration, launched earlier this year, aims to provide a full analytical validation of Illumina’s TruSight Oncology (TSO500) assay, a blood-based test that is
`capable of identifying minute amounts of ctDNA. MoCha chose TSO500 to support several National Cancer Institute (NCI)-sponsored clinical studies after a rigorous review of
`a number of ctDNA assay platforms.
`
`“The TSO500 offers a breadth of coverage,” said Mickey Williams, Ph.D., director of the Molecular Characterization Laboratory. “Many more genes can be interrogated
`compared to other platforms.”
`
`The assay obtains data from the full coding region of 523 genes in cancer-related pathways and can identify all major types of mutations that may occur in those genes.
`
`Importantly, the assay has high specificity, which means that it has a very low likelihood of falsely identifying a cancer mutation in a subject where there is none. The specificity
`of the assay aligns with its main intended use, which is to test several thousand plasma samples from the more than 5,600 patients screened for the NCI Molecular Analysis for
`Therapy Choice (NCI-MATCH) trial.
`
`MoCha plans to use TSO500 to obtain information about rare tumors, to determine how well tumor mutations identified from ctDNA match those identified in solid tumor tissue
`from the same patient, and to gather information about the ctDNA molecular profiles of patients treated with immune checkpoint treatments, which could provide value for
`immunotherapy studies.
`
`There will be three phases to the collaboration with Illumina. The first step is for MoCha to perform optimization and validation of the TSO500, which is already underway. The
`next phase, which is expected to last several years, will be clinical implementation of the assay. The final phase will involve providing genomic support for the NCI’s
`Experimental Therapeutics Clinical Trials Network (ETCTN), which will mainly be retrospective, examining plasma specimens and looking for candidate mechanisms of
`resistance and response to therapies.
`
`For the ETCTN trials, MoCha will be collecting blood throughout the course of a patient’s treatment for ctDNA analysis.
`
`“This will enable us to look at how patients progress and why,” explained Chris Karlovich, Ph.D., associate director of the Molecular Characterization Laboratory.
`
`MoCha staff will compare what they see in the ctDNA at the time progression occurred to what was present at the start of treatment.
`
`“We expect to see new mutations in the progression sample, which may tell us much about how specific cancer types evolve to become resistant to therapy, as well as inform
`the best choice for the next line of treatment,” explained Karlovich.
`
`For MoCha, the ongoing study will further evaluate the TSO 500 as a complement or potential alternative to tissue biopsies for genomic profiling of cancer patients.
`
`This work is scheduled to be presented at American Society of Clinical Oncology Annual Meeting in Chicago during a poster session on Saturday, June 1.
`
`By Max Cole, staff writer
`
`/
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`

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`Case 1:20-cv-01644-RGA Document 1-59 Filed 12/03/20 Page 3 of 3 PageID #: 1365
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`liquid biopsy
`Molecular Characterization Laboratory
`
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`Media Inquiries
`
`Mary Ellen Hackett
`Manager, Communications Office
`
`Frederick National Laboratory for Cancer Research
`301-401-8670
`maryellen.hackett@nih.gov
`
`/
`
`