Blood tester Guardant Health files for Nasdaq IPO

Cancer blood test maker Guardant Health plans to go public, filing an initial public offering on the Nasdaq using the symbol GH.

Its preliminary filing proposes a $100 million offering, but the Redwood City, California-based company describes that number as an estimate solely for calculating registration fees and is subject to change. The total number of shares and price per share have not yet been disclosed.

A member of last year’s class of the FierceMedTech Fierce 15, Guardant raised $360 million in May 2017 to sequence tumor DNA from 1 million cancer patients. The company describes its Guardant360 assay as the most widely ordered comprehensive liquid biopsy on the market, with over 5,000 oncologists ordering more than 70,000 tests since its 2014 launch, to scan patient blood draws for 73 cancer genes.

In 2017 alone, Guardant sold 25,754 tests to clinical customers, up from 18,643 the year before, as well as 6,141 to biopharma customers, up from 1,830.

In its prospectus, Guardant approximated the U.S. market for its current and investigational blood testing products at more than $35 billion—including applications for clinicians and industry customers across all stages of cancer, such as early screening, recurrence detection and late-stage therapy selection.

Last year the company brought in $49.8 million in total revenue, compared to $36.1 million in just the first half of 2018—with net losses of $83.2 million and $35.5 million, respectively.

While its Guardant360 test is not required to be approved by the FDA under current regulations, the company is planning to submit a premarket approval application in a bid to improve its tests’ coverage and reimbursements. The FDA granted the test a breakthrough device designation in January.

"We believe that FDA approval will become increasingly important for diagnostic tests to gain commercial adoption both in the United States and abroad," the company wrote in its prospectus. "We also intend to pursue regulatory approvals in specific markets outside of the United States, including in Japan and China."

In addition, Guardant has established a joint venture with the Tokyo-based conglomerate SoftBank, which led last year’s $360 million funding round, to assist with the commercialization of its products in Asia, the Middle East and Africa, with an initial focus on Japan.

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