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Blue Earth Diagnostics News

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2023
2022
2021
2020
2019
2018
2017
2016
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2014

NEWS FROM

30, May, 2023
U.S. FDA Approves Blue Earth Diagnostics’ POSLUMA® (Flotufolastat F 18) Injection, First Radiohybrid PSMA-targeted PET Imaging Agent for Prostate Cancer
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29, April, 2023
Blue Earth Diagnostics Announces Additional Results from Phase 3 SPOTLIGHT Trial of Investigational PET Imaging Agent 18F-rhPSMA-7.3 in Biochemical Recurrence of Prostate Cancer − Results at the American Urological Association’s 2023 Annual Meeting (AUA2023)
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16, February, 2023
Blue Earth Diagnostics Announces Additional Results from Phase 3 LIGHTHOUSE Trial of Investigational PET Imaging Agent 18F-rhPSMA-7.3 in Newly Diagnosed Prostate Cancer
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09, February, 2023
Blue Earth Diagnostics Highlights Upcoming Presentation of Additional Results from Investigational Phase 3 LIGHTHOUSE Study of 18F-rhPSMA-7.3 in Newly Diagnosed Prostate Cancer
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NEWS FROM

01, December, 2022
Blue Earth Diagnostics Announces Efficacy and Safety Results from Phase 3 LIGHTHOUSE Trial of Investigational PET Imaging Agent 18F-rhPSMA-7.3 in Newly Diagnosed Prostate Cancer
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22, November, 2022
Blue Earth Diagnostics Highlights Presentations on Axumin® (Fluciclovine F 18) at Upcoming RSNA® 2022 Annual Meeting
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21, November, 2022
Blue Earth Diagnostics Highlights Upcoming Presentation of Results from Phase 3 LIGHTHOUSE Study of Investigational PET Imaging Agent 18F-rhPSMA-7.3 in Newly Diagnosed Prostate Cancer
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24, October, 2022
Blue Earth Diagnostics Announces Results on Clinical Factors Impacting Detection Rates from Phase 3 SPOTLIGHT Trial of Investigational PET Imaging Agent 18F-rhPSMA-7.3 in Biochemical Recurrence of Prostate Cancer
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19, October, 2021
Blue Earth Diagnostics Highlights Presentations on Axumin® (Fluciclovine (18F)) and Investigational 18F-rhPSMA-7.3 in Biochemically Recurrent Prostate Cancer at Upcoming ASTRO Annual Meeting
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18, October, 2022
Blue Earth Diagnostics Announces Data-sharing Agreement with Siemens Healthineers and the University Hospital of Technical University of Munich (TUM) for 18F-rhPSMA-7.3, to support AI-based Algorithms Development
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27, September, 2022
Blue Earth Diagnostics Announces FDA Acceptance of New Drug Application for 18F-rhPSMA-7.3, a Radiohybrid Prostate-Specific Membrane Antigen-Targeted PET Imaging Agent for Prostate Cancer
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19, July, 2022
Independent Clinical Studies Published Regarding Performance of Axumin® (Fluciclovine F 18) PET Imaging in Patients with Recurrent Prostate Cancer Undergoing Androgen Deprivation Therapy (ADT)
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15, June, 2022
Blue Earth Diagnostics Announces Reader Reproducibility Results from Phase 3 SPOTLIGHT Trial of Investigational PET Imaging Agent 18F-rhPSMA-7.3 in Biochemical Recurrence of Prostate Cancer
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09, June, 2022
Blue Earth Diagnostics Highlights Presentations on Investigational rhPSMA Radiopharmaceuticals and 18F-Fluciclovine at Upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting
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08, June, 2022
Blue Earth Diagnostics Completes Patient Accrual in Phase 3 REVELATE Clinical Trial of 18F-Fluciclovine PET Imaging for Detection of Recurrent Brain Metastases
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13, May, 2022
Blue Earth Diagnostics Announces Additional Results from Phase 3 SPOTLIGHT Trial of Investigational PET Imaging Agent 18F-rhPSMA-7.3 in Biochemical Recurrence of Prostate Cancer
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05, May, 2022
Blue Earth Diagnostics Highlights Upcoming Presentation of Additional Results from Phase 3 SPOTLIGHT Study of Targeted PET Imaging Agent 18F-rhPSMA-7.3 in Biochemically Recurrent Prostate Cancer
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28, February, 2022
Blue Earth Diagnostics Appoints Dr. David E. Gauden as Chief Executive Officer and Dr. Eugene J. Teoh as Chief Medical Officer
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15, February, 2022
Blue Earth Diagnostics Announces Key Results from Phase 3 SPOTLIGHT Study of 18F-rhPSMA-7.3, an Investigational PET Imaging Agent, in Biochemical Recurrence of Prostate Cancer
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01, February, 2022
Blue Earth Diagnostics Highlights Upcoming Presentation of Key Results from Phase 3 SPOTLIGHT Study of Targeted PET Imaging Agent 18F‐rhPSMA‐7.3 in Biochemically Recurrent Prostate Cancer
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NEWS FROM 2021

30, November, 2021
Blue Earth Diagnostics Highlights Axumin® (Fluciclovine F18) Presentation at Upcoming 22nd Annual Scientific Meeting in Urologic Oncology (SUO)
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19, October, 2021
Blue Earth Diagnostics Highlights Presentations on Axumin® (Fluciclovine F 18) and 18F-Fluciclovine at Upcoming ASTRO Annual Meeting
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27, September, 2021
Blue Earth Diagnostics Announces Results of an Analysis of the Impact of Axumin® (Fluciclovine F 18) PET/CT Imaging on Androgen Deprivation Therapy (ADT) Planning in Recurrent Prostate Cancer
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15, September, 2021
Blue Earth Diagnostics Supports Timely Consideration and Passage of the Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2021 by U.S. Congress.
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08, September, 2021
Blue Earth Diagnostics Highlights Presentations on Axumin® (Fluciclovine F 18) at Upcoming American Urological Association’s 2021 Annual Meeting
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10, August, 2021
Blue Earth Diagnostics Announces Upcoming 18F-Fluciclovine Presentations at 2021 Society of Neuro-Oncology (SNO) Conference on Brain Metastases
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08, June, 2021
Blue Earth Diagnostics Announces Axumin® (Fluciclovine F 18) Presentations at Upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting
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02, June, 2021
Blue Earth Diagnostics Announces Axumin® (Fluciclovine F 18) Presentations at Upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting
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25, May, 2021
The Lancet Publishes Results of Axumin® (Fluciclovine F 18) PET Imaging Study Demonstrating Improved Patient Outcomes in Patients with Recurrent Prostate Cancer
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08, February, 2021
Blue Earth Diagnostics Highlights Presentations on Axumin® (Fluciclovine F 18) at Upcoming 2021 ASCO Genitourinary Cancers Symposium (ASCO GU)
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12, January, 2021
Blue Earth Diagnostics Announces Dosing of Initial Patient in Phase 3 REVELATE Clinical Trial of 18F-Fluciclovine PET Imaging for Detection of Recurrent Brain Metastases
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05, January, 2021
Blue Earth Diagnostics Acquires Exclusive, Worldwide Rights to Therapeutic Applications of Scintomics’ Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) Technology for Prostate Cancer
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NEWS FROM 2020

24, November, 2020
Blue Earth Diagnostics Announces First Patient Doses of PET Imaging Agent rhPSMA-7.3 (18F) in Collaboration with Nucleis Radiopharmaceuticals in Liege, Belgium
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20, October, 2020
Blue Earth Diagnostics Highlights Presentations on Axumin® (Fluciclovine F 18) and 18F-Fluciclovine at Upcoming ASTRO Annual Meeting
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01, July, 2020
Blue Earth Diagnostics Announces Dosing of Initial Patients in Phase 3 SPOTLIGHT Clinical Trial of Targeted PET Imaging Agent rhPSMA-7.3 (18F) in Biochemically Recurrent Prostate Cancer
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16, June, 2020
Blue Earth Diagnostics and PETNET Solutions Announce New Commercial Supply Agreement for Axumin® (Fluciclovine F 18) and Investigational rhPSMA-7.3 (18F) Prostate Cancer Imaging Agent
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18, May, 2020
Blue Earth Diagnostics Announces Results from Early Clinical Experience with Targeted PET Imaging Agent rhPSMA-7.3 (18F) in Men with Intermediate and High-risk Prostate Cancer
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01, May, 2020
Blue Earth Diagnostics CEO Jonathan Allis Appointed Chair of UK Rapid Testing Consortium (UK-RTC) for COVID-19 by UK Department of Health and Social Care
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21, April, 2020
Blue Earth Diagnostics continues to expand access to Axumin® (fluciclovine (18F)) with first commercial supply in Slovakia, Europe
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17, March, 2020
Blue Earth Diagnostics Announces Dosing of First Patient in Phase 3 LIGHTHOUSE Clinical Trial of Targeted PET Imaging Agent rhPSMA-7.3 (18F) in Newly Diagnosed Prostate Cancer
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11, February, 2020
Blue Earth Diagnostics Announces Upcoming Presentations from FALCON Study of Axumin® (Fluciclovine F18) PET/CT Impact on Clinical Management of Recurrent Prostate Cancer
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NEWS FROM 2019

16, September, 2019
Results from Blue Earth Diagnostics’ FALCON Trial Show 64% of Patients with Suspected Recurrent Prostate Cancer Had Change in Management Following Axumin® (Fluciclovine F 18) PET/CT Scan
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10, September, 2019
Blue Earth Diagnostics Highlights Presentations on Axumin® (Fluciclovine F 18), 18F-Fluciclovine and 18F-rhPSMA at Upcoming ASTRO Annual Meeting
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01, August, 2019
Bracco Imaging announces completion of acquisition of Blue Earth Diagnostics
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27, June, 2019
Blue Earth Diagnostics Announces Highlights of Technical University of Munich Presentations on Initial Clinical Experience with 18F-rhPSMA-7 PET Imaging in High Risk Primary and Biochemical Recurrent Prostate Cancer
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26, June, 2019
Blue Earth Diagnostics to be Acquired by Global Leader Bracco Imaging
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26, June, 2019
Blue Earth Diagnostics Announces Results from Investigational Clinical Study of Safety and Effectiveness of 18F-Fluciclovine PET Imaging in Adult Glioma
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12, June, 2019
Blue Earth Diagnostics Highlights Presentations on Axumin® (Fluciclovine F 18), 18F-Fluciclovine and 18F-rhPSMA at Upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting
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09, May, 2019
Blue Earth Diagnostics continues to expand access to Axumin® (fluciclovine (18F)) in Europe
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06, May, 2019
Blue Earth Diagnostics Announces Results of Additional Analyses from LOCATE Trial Evaluating Change in Recurrent Prostate Cancer Management Following Axumin® (Fluciclovine F 18) PET/CT Imaging
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06, May, 2019
Blue Earth Diagnostics Announces Results from Initial Clinical Experience of 18F-rhPSMA-7 PET Imaging in High-risk Primary and Biochemical Recurrent Prostate Cancer by Technical University of Munich
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24, April, 2019
Blue Earth Diagnostics Announces Presentations on Axumin® (Fluciclovine F 18), 18F-Fluciclovine and 18F-rhPSMA at Upcoming American Urological Association’s 2019 Annual Meeting
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16, April, 2019
Blue Earth Diagnostics Announces Addition of Axumin® (fluciclovine (18F)) to EAU Guidelines for imaging in patients with biochemical recurrence in Prostate Cancer
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06, March, 2019
Blue Earth Diagnostics celebrates five year anniversary
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12, February, 2019
First production and administration of Axumin® (fluciclovine (18F)) in Italy.
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06, February, 2019
Blue Earth Diagnostics Announces Axumin® (Fluciclovine F 18) LOCATE Study Presentation at Upcoming ASCO 2019 Genitourinary Cancers Symposium on Impact on Clinical Management of Recurrent Prostate Cancer
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NEWS FROM 2018

12, December, 2018
First production and administration of Axumin® (fluciclovine (18F)) in France.
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10, December, 2018
Blue Earth Diagnostics Announces U.S. Food and Drug Administration (FDA) Filing Acceptance of Supplemental New Drug Application (sNDA) for 18F-fluciclovine PET Imaging in Glioma
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19, November, 2018
Blue Earth Diagnostics Announces Results of Investigational Phase 3 Blinded Image Evaluation Study of 18F-Fluciclovine PET Imaging in Glioma
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14, November, 2018
Blue Earth Diagnostics Announces 18F-Fluciclovine Research Presentation at Upcoming Society for Neuro-Oncology (SNO) Annual Scientific Meeting
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17, October, 2018
Blue Earth Diagnostics Announces Fluciclovine F 18 Research Presentations at Upcoming ASTRO Annual Meeting
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12, October, 2018
Blue Earth Diagnostics wins prestigious “Best Emerging Biotech” award
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02, October, 2018
Axumin® (fluciclovine (18F)) receives positive recommendation from Transparency Committee of the French HAS, for use in PET imaging of suspected recurrent prostate cancer
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11, September, 2018
The Journal of Urology Publishes Results from Blue Earth Diagnostics’ LOCATE Trial of Role of 18F Fluciclovine PET/CT Imaging in the Management of Men with Recurrent Prostate Cancer
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09, August, 2018
Blue Earth Diagnostics shortlisted for prestigious “Best Emerging Biotech Company” award
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25, June, 2018
Blue Earth Diagnostics appoints IASON Sp. z o.o. to manufacture and distribute Axumin® (fluciclovine (18F)) in Poland
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18, June, 2018
Blue Earth Diagnostics Announces Fluciclovine F 18 Research Presentations at Upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting
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21, May, 2018
Results from Blue Earth Diagnostics’ LOCATE Trial Show 59% of Patients with Suspected Recurrent Prostate Cancer Had Change in Management Plan Following 18F Fluciclovine PET/CT Scan
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14, May, 2018
Blue Earth Diagnostics Announces Presentation on Fluciclovine (18F) PET/CT Impact on Clinical Management of Recurrent Prostate Cancer at Upcoming AUA2018, Annual Meeting of the American Urological Association
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02, May, 2018
Blue Earth Diagnostics Expands Oncology Portfolio with Exclusive, Worldwide Licensing of Investigational Radiohybrid PSMA-targeted Agents for Prostate Cancer from Scintomics
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12, April, 2018
Blue Earth Diagnostics opens new headquarters in Oxford
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20, February, 2018
Blue Earth Diagnostics Announces Addition of Axumin® (Fluciclovine F 18) to NCCN Guidelines® for PET Imaging for Suspected Recurrent Prostate Cancer
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06, February, 2018
Blue Earth Diagnostics Announces Presentation at Upcoming ASCO 2018 Genitourinary Cancers Symposium on Fluciclovine (18F) PET/CT Impact on Clinical Management of Recurrent Prostate Cancer
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NEWS FROM 2017

10, October, 2017
Blue Earth Diagnostics and Seibersdorf Laboratories Announce Manufacturing and Distribution Agreements for Axumin® (fluciclovine (18F)) for PET Imaging of Recurrent Prostate Cancer
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02, October, 2017
Blue Earth Diagnostics and GE Healthcare sign UK manufacturing agreement
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06, September, 2017
Blue Earth Diagnostics Announces Late-Breaking Initial Results of Fluciclovine (18F) PET/CT Impact on Clinical Management of Recurrent Prostate Cancer at Upcoming ASTRO Annual Meeting
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30, August, 2017
Blue Earth Diagnostics Named as Finalist in First Annual Xconomy Awards
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11, August, 2017
Blue Earth Diagnostics shortlisted for “Best Emerging Medtech Company” award
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27, July, 2017
Blue Earth Diagnostics appoints M2i to manufacture and distribute Axumin™ in Ireland
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28, June, 2017
Blue Earth Diagnostics joins the British Institute of Radiology
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23, May, 2017
Blue Earth Diagnostics receives marketing authorisation for Axumin™ (Fluciclovine (18F)) for PET imaging of recurrent prostate cancer
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22, May, 2017
Advanced Accelerator Applications and Blue Earth Diagnostics Announce European Manufacturing and Distribution Agreements for Axumin™ (Fluciclovine (18F)) for PET Imaging of Recurrent Prostate Cancer
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12, May, 2017
Blue Earth Diagnostics’ FALCON Trial of Fluciclovine (18F) PET/CT Imaging in Recurrent Prostate Cancer Stops Recruitment after Successful Interim Analysis
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03, May, 2017
Blue Earth Diagnostics Announces Publication of Reader Training Study Results for AxuminTM (Fluciclovine F 18) PET Imaging of Men with Recurrent Prostate Cancer
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24, March, 2017
Blue Earth Diagnostics receives positive CHMP opinion for Axumin™ (Fluciclovine (18F)) for PET imaging of recurrent prostate cancer
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07, February, 2017
Blue Earth Diagnostics and Siemens’ PETNET Solutions Increase Patient Access to Axumin™ (Fluciclovine F 18) Injection PET Imaging Agent for Suspected Recurrent Prostate Cancer
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NEWS FROM 2016

29, November, 2016
Blue Earth Diagnostics and Northern California PET Imaging Center Announce Region’s First Commercial AxuminTM (Fluciclovine F 18) Administration
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25, October, 2016
The Journal of Urology Publishes Blue Earth Diagnostics’ Phase 3 Study Results of AxuminTM (Fluciclovine F 18) for PET Imaging of Recurrent Prostate Cancer
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08, September, 2016
Blue Earth Diagnostics Announces First Commercial Administrations of AxuminTM (Fluciclovine F 18) by Atlanta’s Northside Hospital
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08, September, 2016
Blue Earth Diagnostics Announces AxuminTM (Fluciclovine F 18) Presentations at Upcoming Scientific Conferences
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10, June, 2016
Blue Earth Diagnostics and Siemens’ PETNET Solutions Announce Commercial Availability of AxuminTM (Fluciclovine F 18) Injection for PET Imaging of Recurrent Prostate Cancer
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09, June, 2016
Blue Earth Diagnostics Announces AxuminTM (Fluciclovine F 18) Presentations at Upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting
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03, June, 2016
FDA approves new diagnostic imaging agent to detect recurrent prostate cancer
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03, June, 2016
U.S. FDA Approves Blue Earth Diagnostics’ AxuminTM (Fluciclovine F 18) Injection after Priority Review for PET Imaging of Recurrent Prostate Cancer
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13, May, 2016
Blue Earth Diagnostics Announces Opening of U.S. Office and Expansion of Management Team
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31, March, 2016
Blue Earth Diagnostics begins fluciclovine (18F) studies in Recurrent Prostate Cancer Patients
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24, March, 2016
Blue Earth Diagnostics and Norsk medisinsk syklotronsenter AS announce manufacturing and distribution partnership for Fluciclovine (18F)
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