On December 9, 2020 Zionexa US Corp., a wholly owned subsidiary of Zionexa SAS, specialized in the development and commercialization of in-vivo biomarkers for use in guiding targeted therapies in oncology, reported that the first Cerianna (Fluroroestradiol F-18) doses have been distributed to two oncology imaging centers in the San Francisco area (Press release, Zionexa, DEC 9, 2020, View Source [SID1234572511]). These two doses of Cerianna represent the future for two breast cancer patients to be able to receive PET scans that will have a more direct impact on the course of their therapy, and overall provide them with more informed and better care.
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Cerianna (fluoroestradiol F-18) injection is a new molecular imaging agent approved by the Food and Drug Administration (FDA) indicated for use in positron emission tomography (PET) imaging for the detection of estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer (MBC). Cerianna (fluoroestradiol F-18) is the first FDA-approved F-18 PET imaging biomarker specifically indicated for use in patients with recurrent or metastatic breast cancer. The permanent HCPCS code, A9591 "Fluoroestradiol F 18, diagnostic, 1 millicurie" will be effective January 2021.
"This is a momentous day: our international team worked everyday since the creation of Zionexa to achieve this tremendous milestone. Our mission is to continue this impressive work in order to help improve patient’s quality of life and guiding therapies. Cerianna can help guide therapies for recurrent and MBC patients and our ambition is to provide all patients who have the need for it in the United States," said Peter Webner, CEO of Zionexa US Corp. "Cerianna is already being produced and distributed in San Francisco and we expect to extend to Los Angeles, New York, Philadelphia, Raleigh Durham and Jacksonville next month."
"Siemens’ Healthineers PETNET Solutions is pleased to be the exclusive commercial US manufacturer and distributor of Cerianna" says Barry Scott, Head of PETNET Solutions. "The ability to be able to deliver Cerianna and help provide answers for these patients is a key milestone. Furthermore, PETNET is providing solutions that address society’s most challenging diseases, like breast cancer. Our continued investment in our network will enable us to extend access to a greater population in the coming months."
About Metastatic Breast Cancer
Metastatic breast cancer is the most advanced stage of breast cancer. Also called stage IV or advanced breast cancer, MBC means that the cancer has spread beyond the breast to other parts of the body. MBC affects more than 168,000 patients in the United-States (source: Mariotto et al, 2017).