What Happened?
Shares of diagnostics company Guardant Health (NASDAQ: GH) jumped 1.6% in the morning session after the U.S. Food and Drug Administration (FDA) approved its Guardant360® CDx blood test as a companion diagnostic for Eli Lilly's new advanced breast cancer treatment, Inluriyo™.
The approval allows the test to identify patients with specific ESR1 mutations who may benefit from the new therapy, which is intended for those whose disease has progressed after endocrine therapy. Guardant Health’s chairman and co-CEO, Helmy Eltoukhy, noted that the approval provides expanded access to genomic profiling through a simple blood draw.
This marks the sixth FDA companion diagnostic (CDx) approval for Guardant360 CDx and its second for breast cancer treatment, highlighting the company's continued progress in precision oncology. The news builds on other recent positive developments, including a partnership with Quest Diagnostics to expand access for Shield, Guardant's blood-based colorectal cancer test.
Analyst sentiment also remains positive, with Wells Fargo recently initiating coverage with an “overweight” rating and a $72 price objective.
After the initial pop the shares cooled down to $61.48, up 2.5% from previous close.
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What Is The Market Telling Us
Guardant Health’s shares are extremely volatile and have had 39 moves greater than 5% over the last year. In that context, today’s move indicates the market considers this news meaningful but not something that would fundamentally change its perception of the business.
The previous big move we wrote about was 4 days ago when the stock gained 5.2% on the news that the company announced a collaboration with Quest Diagnostics and provided an upbeat financial outlook at its investor day. The partnership aimed to make Guardant's Shield blood-based cancer screening test more widely available to physicians and patients in the United States. During its investor event, the company also revealed it accelerated its timeline for reaching cash flow breakeven by about 12 months. Furthermore, Guardant projected that its Shield product would generate at least $500 million in annual revenue by 2028. Following these positive announcements, analysts reacted favorably, with JP Morgan raising its price target on the stock to $70 from $60.
Guardant Health is up 93.5% since the beginning of the year, and at $61.48 per share, it is trading close to its 52-week high of $67.42 from August 2025. Investors who bought $1,000 worth of Guardant Health’s shares 5 years ago would now be looking at an investment worth $552.65.
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