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Carlsbad, CA

Developing rapid point-of-care diagnostic tests for verifying biopsy samples to improve cancer diagnosis and patient outcomes.

• Mission: Transforming cancer diagnostics with rapid, point-of-care tests that verify biopsy sample adequacy in real-time, enhancing patient outcomes.  
• Innovation: A breakthrough diagnostic technology that provides pathology results within five minutes, enabling immediate feedback during the biopsy procedure.  
• Market Opportunity: Targeting lung cancer initially, with plans to expand to other cancer types like breast, liver, and pancreatic cancer, significantly broadening market potential.  
• Clinical Advancements: Positive FDA pre-submission feedback and ongoing clinical studies, with FDA submission planned for 2025.  
• Impact on Healthcare: Aims to streamline the biopsy process, reduce delays in diagnosis, minimize patient stress, and improve treatment timelines.  
• Strategic Vision: Positioning to improve the standard of care in oncology by addressing a critical gap in cancer diagnostics and accelerating the path to treatment.

ROSE Diagnostics is raising funds to accelerate the development of a rapid point-of-care test designed to verify cancer biopsy sample adequacy in real-time, providing clinicians with immediate feedback. The company’s initial focus is on lung cancer, aiming to improve diagnostic accuracy, reduce delays in treatment, and minimize patient stress by enabling biopsy sample review at the time of procedure. The technology provides results within five minutes, making it a potentially transformative tool for oncology care. ROSE Diagnostics is working toward pivotal clinical studies, with an FDA submission planned for 2025.

The company aims to expand its solution to other cancer types, including breast, liver, and pancreatic cancer, significantly broadening the potential impact of its technology. By streamlining the biopsy process and accelerating diagnosis, ROSE Diagnostics plans to reduce the time it takes to obtain results, thus enhancing treatment timelines and patient outcomes. The company has already made significant progress with over 3,000 lab tests, positive FDA feedback, and ongoing clinical studies. ROSE Diagnostics is well-positioned to make a substantial impact on cancer diagnostics by addressing a critical gap in the diagnostic process and improving the overall quality of care for cancer patients.

Company Info

ROSE Diagnostics is focused on developing rapid, point-of-care tests to verify biopsy samples and accelerate cancer diagnosis.

ROSE Diagnostics is developing a rapid, point-of-care test aimed at reducing the stress, time, and cost associated with cancer biopsies by enabling pathology review during the biopsy procedure itself. Their initial focus is on lung cancer, a leading cause of cancer-related deaths in the U.S., with a rapid test designed to verify the biopsy sample within 5 minutes. This quick verification process helps clinicians make informed decisions and reduces unnecessary patient recalls. The company’s technology features a compact, affordable reader and disposable test cartridges, which streamline the biopsy process and improve diagnostic efficiency.

With over 200,000 new cases of lung cancer annually in the U.S., ROSE Diagnostics addresses a significant market need for faster, more accurate biopsy sample verification. The company is also exploring the expansion of its technology to other cancer types, including liver, pancreatic, and breast cancer, which could potentially double the addressable market. ROSE has already conducted extensive lab tests and received positive FDA pre-submission feedback, with clinical studies planned for 2025. The company is positioning its solution to enhance patient outcomes, lower healthcare costs, and raise the standard of care for cancer diagnosis.