The company first achieved success with its Guardant360 product, a liquid biopsy used to help determine the appropriate therapy for cancer patients. The Guardant360 CDx product is the first liquid biopsy approved by the U.S. Food and Drug Administration (FDA) for all advanced solid tumors. It's also used as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who could potentially benefit from treatment with AstraZeneca's (AZN -0.13%) Tagrisso, Johnson & Johnson's (JNJ -1.07%) Rybrevant, or Amgen's (AMGN -0.32%) Lumakras.
Guardant Health also offers a tissue biopsy product, Guardant360 TissueNext, designed to be ordered with the Guardant360 CDx test. Its Guardant360 Response test helps doctors determine if a cancer therapy is working with patients. In addition, Guardant Health markets Guardant Reveal, the first blood-only test that can detect residual and recurrent cancer in less than two weeks without requiring a tissue biopsy.
The company's total addressable market in cancer treatment selection and recurrence monitoring is about $30 billion per year. However, Guardant Health has a much larger market opportunity of $50 billion annually in the U.S. alone for early-stage cancer detection.
Guardant Health won U.S. Food and Drug Administration (FDA) approval for its Shield blood test for screening colorectal cancer in July 2024. The company hopes to expand Shield to include lung cancer as the next step in its goal to have a multicancer early-stage test.