Giulia KennedyPhD
VeracyteChapter 06 · Strand A · Company

Veracyte

Bonnie Anderson's first executive hire at Veracyte in 2008. As Chief Scientific Officer, then Chief Medical Officer, she led the science behind Afirma, Percepta and Envisia over fourteen years.

APR 2008 – DEC 2022CHIEF SCIENTIFIC OFFICER; CHIEF MEDICAL OFFICER FROM 2018; GLOBAL CHIEF SCIENTIFIC OFFICER AND CHIEF MEDICAL OFFICER FROM 2022VERACYTE, INC. · SOUTH SAN FRANCISCO, CALIFORNIA

Overview

Giulia Kennedy joined Veracyte in April 2008 as Senior Vice President of Research and Development and was named Chief Scientific Officer that September.1 She was the first executive hired by co-founder and chief executive Bonnie Anderson, in the year Veracyte counts as its founding.2 The company itself had been incorporated in 2006 as Calderome, Inc. and took the Veracyte name in March 2008.3

Her remit grew with the company. In January 2018 Veracyte folded its scientific, clinical and medical affairs functions into a single department under her, and she added the title of Chief Medical Officer.45 On January 6, 2022, after acquisitions had made Veracyte a global business, she was named Global Chief Scientific Officer and Chief Medical Officer, overseeing a worldwide team spanning research and development, medical affairs, data science and clinical affairs.6

Contributions

Veracyte’s own biography credits her with overseeing the development of three commercialized genomic tests that reduce unnecessary surgeries by resolving diagnostic uncertainty: Afirma for thyroid nodules, Percepta for lung nodules and Envisia for idiopathic pulmonary fibrosis.7 Each is told in its own chapter. By 2026 her biography counted eight genomic diagnostic tests developed and commercialized under her leadership.8

The research record from these years is consistent: high-dimensional RNA data, machine learning and prospective clinical validation, applied to questions where the alternative was a surgery that often proved unnecessary.

Departure

On December 9, 2022, Kennedy and Veracyte agreed that she would leave the company effective December 31, 2022. The Form 8-K disclosing the separation noted an additional payment made “in appreciation for all of Dr. Kennedy’s contributions as one of the first employees of the Company”.9 The following spring the company’s proxy statement recorded that she had departed “after a long and successful career of leading the company as its Global Chief Scientific Officer and Chief Medical Officer whereby she was instrumental in developing the company’s innovative products”.10

Roles

  1. APR 2008 – SEP 2008Senior Vice President, Research and Development1
  2. SEP 2008 – JAN 2018Chief Scientific Officer15
  3. JAN 2018 – JAN 2022Chief Scientific Officer and Chief Medical Officer54
  4. JAN 2022 – DEC 2022Global Chief Scientific Officer and Chief Medical Officer69
From the record

Facts

  • Joined Veracyte in April 2008 as Senior Vice President of Research and Development and became Chief Scientific Officer in September 2008.15
  • Was the first executive hire by co-founder and CEO Bonnie Anderson in 2008, and is described by Veracyte as one of the company's first employees.294
  • Became Chief Medical Officer in January 2018, in addition to Chief Scientific Officer, when Veracyte consolidated its scientific, clinical and medical affairs functions into one department under her leadership.54
  • Before the 2018 expansion her title was Chief Scientific Officer and Senior Vice President of Research, Product and Clinical Development, by which time she had overseen the development of three commercialized genomic tests.7
  • Named Global Chief Scientific Officer and Chief Medical Officer on January 6, 2022, overseeing a worldwide team of research and development, medical affairs, data science and clinical affairs professionals.6
  • On December 9, 2022 she and Veracyte agreed that she would depart the company effective December 31, 2022, as disclosed in a Form 8-K.910

Contributions

  • Oversaw the development of three commercialized genomic tests (Afirma, Percepta, Envisia) that help reduce unnecessary surgeries by resolving diagnostic uncertainty.7
  • By 2026 her biography credited her with leading the development and commercialization of eight genomic diagnostic tests at Veracyte.8
  • Veracyte's 2023 proxy statement described her as instrumental in developing the company's innovative products.10

Research

  • Thyroid nodule genomic classification

    APR 2008 – DEC 2022

    The programme that defined Veracyte, where Kennedy was Chief Scientific Officer from 2008 and Chief Medical Officer from 2018. The Afirma Gene Expression Classifier was developed from 315 nodules (JCEM, 2010), launched in January 2011 and validated prospectively in 3,789 patients (NEJM, 2012). The RNA sequencing-based Afirma GSC followed in 2017, validated in JAMA Surgery (2018) with at least one third more benign calls than the original test, and was extended with the Xpression Atlas of variants and fusions, Hürthle cell and medullary thyroid carcinoma classifiers. By January 2018 Veracyte had performed 100,000 Afirma tests.

  • Pulmonary genomic classifiers

    APR 2015 – APR 2024

    Veracyte's second and third commercial tests took the thyroid approach to the lung. Percepta, launched April 16, 2015, classifies lung nodules that are inconclusive by bronchoscopy from bronchial brushings; Envisia, launched October 25, 2016, identifies the usual interstitial pneumonia pattern of idiopathic pulmonary fibrosis in transbronchial biopsies without surgical lung biopsy, and received Medicare coverage effective April 1, 2019. Kennedy is an author of the Envisia development and validation papers (Annals ATS 2017, BMC Genomics 2018, Lancet Respiratory Medicine 2019, AJRCCM 2021), the Percepta analytical and GSC papers, and the 2024 Chest validation of the Percepta Nasal Swab.

  • Machine learning for clinical diagnostics

    DEC 2010 – PRESENT

    The method that links every classifier Kennedy has helped build since 2010: training algorithms on high-dimensional genomic data from clinical samples and validating them against histopathology. She presented on Veracyte's use of machine learning to translate genomic data into commercial diagnostic tests at the Precision Medicine World Conference in January 2018, and described the Afirma GSC's ensemble machine learning algorithms as deriving "from years of thoughtful scientific research, data analysis and statistical modeling". The same approach underlies the Envisia and Percepta classifiers and PinkDx's whole-transcriptome vaginal swab test.

Technologies
  • Afirma Gene Expression Classifier
  • Afirma Genomic Sequencing Classifier
  • Percepta Bronchial Genomic Classifier
  • Envisia Genomic Classifier
  • Whole-transcriptome RNA sequencing
  • Ensemble machine learning classifiers

Publications

Achievements

  1. JAN 2011milestone

    Commercial launch of Afirma

    Veracyte launched the Afirma Thyroid FNA Analysis, its first commercial product, combining cytopathology with the 142-gene Afirma Gene Expression Classifier for thyroid nodules that cytology leaves indeterminate.311

  2. 30 OCT 2013milestone

    Veracyte initial public offering

    Veracyte priced an initial public offering of 5,000,000 shares at $13.00 per share and began trading on the NASDAQ Global Market under the symbol VCYT; the offering closed on November 4, 2013.12131

  3. 25 JAN 2018milestone

    100,000th Afirma genomic test

    Veracyte announced it had performed more than 100,000 Afirma genomic tests since the 2011 introduction and estimated that more than 40,000 patients had been spared unnecessary thyroid surgery.1114

  4. 4 MAR 2019regulatory

    Medicare coverage for the Envisia Genomic Classifier

    Veracyte received a final Medicare local coverage determination for the Envisia Genomic Classifier through Palmetto GBA's MolDX program, effective April 1, 2019.15

Impact

  • COMMERCIAL LAUNCH OF AFIRMA

    The first commercialized test developed under Kennedy as Chief Scientific Officer.

  • VERACYTE INITIAL PUBLIC OFFERING

    Kennedy was an executive officer named in the registration statement.

  • 100,000TH AFIRMA GENOMIC TEST

    Quantified clinical impact of the thyroid franchise Kennedy led scientifically.

  • MEDICARE COVERAGE FOR THE ENVISIA GENOMIC CLASSIFIER

    Reimbursement, rather than FDA clearance, was the key gate for Veracyte's laboratory-developed tests.

Impact across the career