GE Healthcare Buys Zionexa, a Breast Cancer Dx Startup

GE Healthcare acquired Zionexa, a developer of in-vivo oncology and neurology biomarkers that help enable more personalized healthcare. The company aims to develop and bring to market Zionexa’s pipeline biomarkers, as well as the recently FDA-approved PET imaging agent, Cerianna (fluoroestradiol F-18), an adjunct to biopsy to detect estrogen receptor (ER) positive lesions to help inform treatment selection for recurrent or metastatic breast cancer patients.
 
It is estimated 168,000 people have metastatic breast cancer (“Stage 4”) in the U.S.¹, with a five-year survival rate of 28 percent². Cerianna has been commercially available in the U.S. since December 2020 and today is accessible to approximately 25 percent of the relevant patient population. GE Healthcare’s Pharmaceutical Diagnostics business—the global leader in pharmaceutical imaging agents—aims to scale Cerianna to be accessible to a minimum of 75 percent of patients by 2023.
 
Kevin O’Neill, president and CEO of GE Healthcare Pharmaceutical Diagnostics, told the press: “Like GE Healthcare, Zionexa’s products are aimed at enabling more precise diagnosis, improved treatment decision-making and ultimately better clinical outcomes for patients. This acquisition further demonstrates our commitment to enabling precision health and providing innovations that support oncologists, nuclear medicine specialists and other physicians throughout a cancer patient’s journey, from initial screening and diagnosis to informing therapy selection and monitoring the effectiveness of treatment.”
 
Zionexa, a privately-owned company formed in 2018 and headquartered in Aubière, France, employs 24 people in France and the U.S., all of whom will transfer to GE Healthcare. Additionally, GE Healthcare will hire approximately 70 new employees in the company’s U.S. Pharmaceutical Diagnostics team, headquartered in Marlborough, Mass. 
 
Olivier Carli, President of Denos, the majority owner of Zionexa, said: “We expect GE Healthcare Pharmaceutical Diagnostics’ acquisition to allow Zionexa to accelerate the development of its promising R&D pipeline as well as its commercial footprint, while providing Zionexa’s team with access to global and complementary expertise.”
 
Currently, when treating metastatic breast cancer patients, oncologists base clinical decisions on biopsy results which only represent the sampled area of the tumor. However, estrogen receptor (ER) expression—one of the most common breast cancer biomarkers—can vary both within the primary tumor and across different lesions³. Cerianna widens the diagnostic lens for oncologists with a whole-body view of ER positive lesions, helping to provide the patient with a more informed diagnosis, potentially enabling more targeted and individualized treatment plans and avoiding the selection of inappropriate or less effective therapies.
 
Dr. Hannah M Linden, Breast Medical Oncologist, UW Medicine, University of Washington Fred Hutchison Cancer Research Center and Seattle Cancer Care Alliance in Seattle, who has conducted research and authored multiple papers on fluoroestradiol F-18, explained: “Making Cerianna more widely available is an important moment for cancer patients and a significant step forward for molecular imaging. We test ER expression in a metastatic biopsy once at the beginning of the patient’s journey and we make decisions all along—when to give chemotherapy, when to use endocrine therapy, whether or not to use targeted agents—based on that one measurement. Since we know that ER expression can change with time and treatment, imaging with 18F-fluoroestradiol at critical decision points could help clinicians predict response to endocrine therapy and select optimal treatment timing and sequencing.”