Blue Earth Diagnostics to Highlight New POSLUMA® (Flotufolastat F 18) Study Results in Prostate Cancer at the 2026 ASCO Genitourinary Symposium (ASCO GU)

BOSTON, Feb. 18, 2026 /PRNewswire/ -- Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative positron emission tomography (PET) radiopharmaceuticals, today announced that multiple presentations featuring POSLUMA® (flotufolastat F 18) will be presented at the upcoming ASCO 2026 Genitourinary Cancers Symposium (ASCO GU). The conference will be held in San Francisco, Calif., from February 26-28, 2026.

Presentations include results from the first intra-patient, head-to-head comparator study of urinary radioactivity between POSLUMA and piflufolastat F 18 in men with low prostate-specific antigen (PSA) biochemical recurrence following radical prostatectomy. Additional presentations will feature post-hoc analyses from Blue Earth Diagnostics' Phase 3 SPOTLIGHT and LIGHTHOUSE studies, evaluating the diagnostic performance of 18F-flotufolastat PET/CT in men with suspected biochemical recurrence and newly diagnosed prostate cancer. The presentations will include comparisons with baseline conventional imaging (BCI), as well as additional analyses focused on the assessment of bone metastases.

"At ASCO GU, we're pleased to share new data offering deeper insights into the performance of POSLUMA across clinically important prostate cancer settings, including results from our head-to-head comparator study, as well as additional analyses in biochemical recurrence and newly diagnosed disease," said Marco Campione, President and CEO of Blue Earth Diagnostics. "These presentations reflect our ongoing commitment to advancing molecular imaging with high-quality evidence that can help inform clinical decision-making, particularly in scenarios where earlier or clearer detection may influence patient management. We look forward to engaging with the oncology community in San Francisco as the field continues to evolve."

Moderated poster presentation sessions will take place on Thursday, February 26, 2026 at 11:30 – 12:45 p.m. and 5:45 – 6:45 p.m. (PST) at the Hall of the George R. Moscone Convention Center, and will also be available On Demand.

Blue Earth Diagnostics invites participants at ASCO GU to attend the presentations below. Participants onsite are also invited to visit Blue Earth Diagnostics' booth (#15). For full session details and scientific presentation listings, please see the ASCO GU online program here.

ASCO GU 2026 Scientific Presentations Featuring POSLUMA (Flotufolastat F 18)
DATE: Thursday, February 26, 2026 
Title: An intra-patient contemporaneous comparison of 18F-piflufolastat and 18F-flotufolastat urinary radioactivity and local and pelvic region detection rates in men with low prostate-specific antigen biochemical recurrence of prostate cancer after radical prostatectomy
Presenter: Brian T. Helfand, MD, Endeavor Health, Glenview, Illinois
Session Type: Poster Presentation A13
Session Time: 11:30 – 12:45 PM; 5:45 – 6:45 PM PST
Abstract ID: 32

DATE: Thursday, February 26, 2026
Title: Diagnostic performance of 18F-flotufolastat PET/CT compared with conventional imaging for detection of pelvic lymph node metastases in men with newly diagnosed prostate cancer: Descriptive post-hoc analysis from the phase 3 LIGHTHOUSE study
Presenter: Devaki Shilpa Surasi, MD, The University of Texas, MD Anderson Cancer Center, Houston, Texas
Session Type: Poster Presentation K3
Session Time: 11:30 – 12:45 PM; 5:45 – 6:45 PM PST
Abstract ID: 311

DATE: Thursday, February 26, 2026
Title: Diagnostic performance of ¹⁸F-flotufolastat PET/CT compared with conventional imaging in men with biochemical recurrence of prostate cancer: descriptive post-hoc analysis from the Phase 3 SPOTLIGHT study 
Presenter: Ashesh Jani, Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia
Session Type: Poster Presentation A11
Session Time: 11:30 – 12:45 PM; 5:45 – 6:45 PM PST
Abstract ID: 30  

DATE: Thursday, February 26, 2026
Title: Detection of bone metastases in men with low PSA biochemical recurrence of prostate cancer with 18F-flotufolastat PET/CT: A post-hoc analysis from the phase 3 SPOTLIGHT study
Presenter: Ashesh B. Jani, Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia
Session Type: Poster Presentation A12
Session Time: 11:30 – 12:45 PM; 5:45 – 6:45 PM PST
Abstract ID: 31

DATE: Thursday, February 26, 2026
Title: Sequential flotufolastat-F18 PSMA-PET scans to enhance detection of prostate cancer in patients with early PSA recurrence following radical prostatectomy
Presenter: Rajesh Sehgal, MD, AdventHealth Cancer Institute Orlando, Orlando, Florida
Session Type: Poster Presentation A6
Session Time: 11:30 – 12:45 PM; 5:45 – 6:45 PM PST
Abstract ID: 25

About Blue Earth Diagnostics
Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company's success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics' expanding portfolio encompasses a variety of disease states, including oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in diagnostic imaging. For more information, please visit: www.blueearthdiagnostics.com.

About Bracco
Bracco Group is founded in 1927, operates in the healthcare sector across more than 100 countries and is a recognized global leader in diagnostic imaging. With a workforce of over 3,800 employees and consolidated annual revenues of approximately €2 billion—88% generated from international markets—Bracco demonstrates a strong commitment to innovation by investing around 9% of its reference turnover in Research & Development. These investments are primarily focused on imaging diagnostics and medical devices. The Group holds more than 2,000 active patents worldwide.

Discover Bracco at www.bracco.com.

POSLUMA is a registered trademark of Blue Earth Diagnostics.

U.S. Indication and Important Safety Information About POSLUMA

INDICATION                      

POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

• with suspected metastasis who are candidates for initial definitive therapy
• with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

IMPORTANT SAFETY INFORMATION

• Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
• Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
• POSLUMA use contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
• The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
• Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.

To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf.

Contact:
For Blue Earth Diagnostics
Monica Planinsek
Corporate Communications Manager
[email protected]
(M) (207) 838-3863

Media
Shannon Moore
[email protected]
(M) (714) 348-4838

SOURCE Blue Earth Diagnostics