BURLINGTON, Mass. & OXFORD, England--(BUSINESS WIRE)--Blue Earth Diagnostics, a molecular imaging diagnostics company, today announced results from an investigational Phase 3 blinded image evaluation (BIE) study of the diagnostic efficacy of 18F-fluciclovine positron emission tomography (PET) imaging, as an adjunct to magnetic resonance imaging (MRI), in adults with glioma. The primary aim was to determine the diagnostic performance of 18F-fluciclovine PET when combined with MRI (CE-T1W MRI), compared to that of MRI (CE-T1W MRI) alone. Results demonstrated that the overall ability of the readers to assess the diagnostic performance of 18F-fluciclovine with MRI had a Positive Predictive Value (PPV) of more than 90%. 18F-fluciclovine is a synthetic amino acid labeled with the radioisotope F 18, enabling PET imaging to visualize the increased amino acid transport that occurs in malignant tumors such as glioma. Glioma is a serious and life-threatening condition accounting for about 80% of all malignant brain tumors.

18F-fluciclovine under the tradename Axumin® (fluciclovine F 18 injection) is an FDA-approved molecular imaging agent indicated for PET imaging in men with suspected prostate cancer recurrence based on elevated blood levels of prostate specific antigen (PSA) following prior treatment. 18F-fluciclovine PET imaging is being investigated for the detection and continuing assessment of glioma. (For additional product information please see the end of this news release.)

Results of the study were presented in a Poster Session, “A blinded image evaluation study to determine the diagnostic efficacy of 18F-fluciclovine PET, as an adjunct to MRI imaging, in adults with glioma,” by Matthew P. Miller, PhD, Blue Earth Diagnostics, Oxford, UK at the 23rd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology, in New Orleans, La., from November 15 - 18, 2018.
“It is a great pleasure to share results from the 18F-fluciclovine PET blinded image evaluation study in glioma with the prestigious clinical community at the Society of Neuro-Oncology,” said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. “18F-fluciclovine PET is designated as an Orphan Drug by the FDA and EMA for the diagnosis of glioma, and Blue Earth Diagnostics is investigating its potential use in adults with glioma as part of our mission to develop and commercialize innovative PET imaging agents to address unmet medical needs in cancer. We look forward to publishing the full results of this study in an upcoming peer-reviewed medical journal.”

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