#United States #Carlsbad #ROSE Diagnostics #verifi LUNG Test #clinical study

ROSE Diagnostics Breaks New Ground in Lung Cancer Diagnostics

ROSE Diagnostics Inc., headquartered in Carlsbad, California, recently achieved a substantial milestone by enrolling its first patient in a clinical study for its groundbreaking verifi™ LUNG Test. This important step not only signifies the start of practical patient evaluation but also lays the foundation for further clinical validation and future use of the technology in medical settings.

The need for efficient diagnostic solutions in lung cancer is critical, given that currently up to 40% of lung biopsy samples are deemed inadequate. This inadequacy often leads to additional, unnecessary procedures, which can increase patient anxiety and prolong the time taken to reach a proper diagnosis. The innovative verifi LUNG Test offers a game-changing solution by enabling physicians to quickly test biopsy samples immediately in the operating room, thus determining their viability for laboratory analysis on the spot. This immediate feedback can expedite the diagnosis process considerably, allowing lung cancer patients to commence treatment at an earlier stage of the disease. This is crucial in reducing mortality risks associated with delayed treatment.

The clinical study aims to gather lung biopsy specimens from a total of 100 patients to assess and characterize this new type of sample. This diverse data collection will aid in optimizing the final design of the verifi LUNG Test system. The study includes fresh specimens from the prestigious Coastal Pulmonary Associates Scripps Health Network in Encinitas, California, as well as frozen samples sourced from the Firestone Institute for Respiratory Health in Hamilton, Canada. The research is spearheaded by principal investigators Dr. Samir Makani from Scripps and Dr. Eldar Priel from Firestone, both of whom bring extensive expertise and experience to this significant project.

Since initiating on November 27, 2024, the clinical study at the Firestone Institute is anticipated to yield crucial insights that will guide the final stages of development for the verifi LUNG Test System. Following this initial study, ROSE Diagnostics plans to launch two additional clinical performance studies throughout 2025, starting with a pilot study in the first quarter, followed by a pivotal study later in the year.

ROSE Diagnostics is committed to transforming the cancer diagnostics landscape by effectively linking pathology labs with clinical practices. The potential of the verifi LUNG Test is vast, presenting the prospect of more timely and reliable results that can dramatically improve patient outcomes in lung cancer diagnoses. This initiative is part of ROSE Diagnostics' broader mission to innovate cancer testing methodologies and enhance the overall efficiency of healthcare services.

In a further effort to boost its research and development, ROSE Diagnostics is inviting the public to partake in their mission by becoming investors through platform StartEngine. As with any investment, it's important to note that this offering is speculative and carries a significant degree of risk, including the risk of losing the entire investment.

Founded in 2023, ROSE Diagnostics exists to refine and expedite pathology services involved in cancer biopsy procedures. The company's team of skilled professionals is equipped with a wealth of knowledge spanning diagnostics, clinical applications, and navigating regulatory environments, ensuring that they remain at the forefront of cancer diagnosis innovation.

For those interested in learning more about ROSE Diagnostics and their innovative solutions, further details can be found on their website at www.rose-dx.com.

In summary, the enrollment of the first patient is just the beginning. ROSE Diagnostics is on the path to making significant strides that could revolutionize lung cancer diagnostics and, ultimately, patient care.