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PALO ALTO, Calif. - Guardant Health, Inc. (NASDAQ:GH), a precision oncology company, announced that its Shield blood test for colorectal cancer (CRC) screening has been granted Advanced Diagnostic Laboratory Test (ADLT) status by the Centers for Medicare & Medicaid Services (CMS). This designation, effective from April 1, 2025, will allow for a specific market-based Medicare pricing of $1,495 during the initial nine-month period.
Shield, which received FDA approval in July 2024, is recognized as the first blood test for primary CRC screening and is already covered by Medicare. The ADLT status confirms that Shield provides unique clinical insights that are not available through other methods.
During the ADLT period, Guardant Health will gather and analyze payment rate data from private payers. The median of this data will subsequently determine the Medicare pricing for Shield, which will be effective from January 1, 2026, to December 31, 2027.
AmirAli Talasaz, co-CEO of Guardant Health, expressed that the ADLT status not only underscores the test’s value but also supports its wider adoption. He anticipates that the more favorable Medicare rate will facilitate the company’s efforts to expand commercial infrastructure and make Shield available to a broader patient population.
The Shield blood test is approved for non-invasive primary screening of CRC in average-risk individuals aged 45 and older. Guardant Health specializes in blood and tissue tests, real-world data, and AI analytics to enhance patient care and accelerate cancer therapies.
This announcement is based on a press release statement from Guardant Health, Inc. and does not include any independent verification of the claims. The company’s forward-looking statements involve risks and uncertainties, and actual results may differ from those expressed. Guardant Health cautions that these statements should not be considered as guarantees of future performance.
In other recent news, Guardant Health’s financial performance has been a focal point, with several analysts adjusting their price targets and ratings. Canaccord Genuity, BTIG, and Bernstein SocGen Group have all raised their price targets for Guardant Health to $60, maintaining positive ratings, reflecting confidence in the company’s financial trajectory and market position. Guardant Health’s fourth-quarter earnings for 2024 met expectations, with revenues reaching $202 million, surpassing consensus estimates by 7%. The company’s gross margin was reported at 62%, also exceeding estimates.
Guardant Health projects 2025 revenues between $850 million and $860 million, with non-GAAP gross margins of 62-63%. The company’s Shield and Reveal tests, particularly the latter due to expanded reimbursement, are expected to drive future growth. Morgan Stanley also maintained an Overweight rating, raising its price target to $52, indicating optimism about Guardant Health’s growth trajectory. The company anticipates revenue from its Shield test to reach between $25 million and $30 million in 2025.
Analysts highlighted the company’s strong position in the therapy selection and MRD sectors, despite noting concerns about near-term cash burn. Guardant Health’s commitment to its product line and confidence in executing its 2025 guide have been emphasized as key factors for continued growth. Overall, these developments suggest a positive outlook for Guardant Health, with analysts pointing to potential catalysts that could drive performance throughout the year.
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