Guardant Health

Market position

A publicly traded precision oncology company; a directory listing names GRAIL, Freenome and NeoGenomics as competitors. In colorectal cancer screening, a competing stool-based test was reported as 92 percent accurate versus the 83 percent reported for Guardant's blood test in its 2022 study readout.

Positioned as offering biopsy-free, blood-based tumor sequencing that tracks tumor genomics in real time, with claims of the first U.S. FDA-approved blood tests for comprehensive genomic testing and for primary colorectal cancer screening, and a product line spanning screening, early-stage recurrence monitoring, advanced cancer treatment selection and biopharma services.

Technology

The technology sequences circulating tumor DNA — fragments of DNA shed into the bloodstream by dying tumor cells — from blood samples to identify actionable tumor genomic alterations, assess treatment response, detect residual disease and detect early signs of cancer. The company positions this as faster than tissue-based methods and performable in a doctor's office.

Go-to-market

Direct sales of laboratory tests to oncologists and healthcare providers, supported by payer reimbursement (Medicare and commercial coverage) and a patient support program, Guardant Access, that assists with insurance eligibility, claims appeals, billing and financial assistance. The company also partners with the National Cancer Institute, large pharmaceutical companies, academic medical centers and patient advocacy organizations such as Susan G. Komen, the Colon Cancer Coalition and Fight Colorectal Cancer, and used a joint venture with SoftBank to reach markets in Africa, Asia and the Middle East.

Oncologists and other physicians ordering tests for patients across all cancer stages, patients undergoing colorectal cancer screening, third-party insurers as payers, and biopharmaceutical companies using the tests and data for drug development.

Geography

Corporate headquarters in Palo Alto, California (approximately 250,000 sq ft at the former Hewlett Packard Enterprise campus), a laboratory in Redwood City, California, and offices and labs in Torrey Pines, San Diego (37,000 sq ft, 55 employees as of 2022). Roughly 900 of about 1,400 employees were in California as of 2022. International expansion into Africa, Asia and the Middle East ran through the Guardant Health AMEA joint venture, and Guardant360 CDx received Japanese regulatory approval as a companion diagnostic.

History

Wikipedia dates the company's founding to 2012, with co-founders Helmy Eltoukhy and AmirAli Talasaz establishing it during 2012–2013; one directory also lists Michael Wiley among founders. Guardant360 went on sale to oncologists in 2014. The company held 40 patents by 2015, announced clinical trial results in 2016 showing detection of disease-associated mutations also present in 94%–100% of solid tissue samples, and launched GuardantOMNI in 2017. It went public on Nasdaq in 2018, raising $237.5 million at a $3.3 billion valuation. Medicare coverage of Guardant360 began in 2018 for select lung cancer patients and expanded to solid tumors in 2019, followed by FDA approval in 2020. In December 2022 it reported results of a 20,000-participant colorectal cancer screening study begun in 2019, and in 2022 it acquired the Guardant Health AMEA joint venture for roughly $178 million.

Risks & controversies

In December 2022, results of the company's 20,000-participant colorectal cancer screening study showed 83 percent accuracy in detecting cancer with a 10 percent false positivity rate; Bloomberg reported this fell short of the 85 percent investors expected and the stock price declined, with a competing stool-based test reported at 92 percent accuracy. Sources also show inconsistencies in reported founding year (2011 internally versus 2012 per Wikipedia) and total funding figures ($550 million per Wikipedia, more than $500 million per one funding report, $1.9 billion per a startup directory).