NEWS BRIEF

Pharmaceutical Diagnostics today
GE HealthCare’s Pharmaceutical Diagnostics (PDx) segment develops and manufactures pharmaceutical imaging agents used to support over 119 million patient imaging procedures per year - equivalent to four patient procedures every second - across all major care pathways. With over 4,000 employees globally and seven current Good Manufacturing Practice (cGMP) manufacturing sites, Pharmaceutical Diagnostics products are used in 100+ countries.

Recent news announcements focus on offering more choice in Contrast Media and shaping the future of Molecular Imaging to enable Precision Care.

GE HealthCare’s work, and investment, in these areas aim to address healthcare professionals’ unmet needs and secure future supply of iodinated contrast media.

*NEW* FDA approval of Flyrcado (flurpiridaz F 18) injection PET radiotracer for enhanced diagnosis of coronary artery disease
The U.S. Food and Drug Administration (FDA) has granted approval of Flyrcado™ (flurpiridaz F 18) injection , a first of its kind positron emission tomography myocardial perfusion imaging (PET MPI) agent, for the detection of coronary artery disease (CAD). Indicated for patients with known or suspected CAD, Flyrcado delivers higher diagnostic efficacy compared to single-photon emission computed tomography (SPECT) MPI, the predominant procedure used in nuclear cardiology today. Flyrcado, which can be manufactured in an offsite pharmacy and delivered as a ready-to-use unit dose, has the potential to expand clinician and patient access to PET MPI, including improved diagnostic accuracy in difficult-to-image patients such as those with a high body mass index (BMI) and women. With a half-life over ten times longer than currently commercialized cardiac PET radiotracers, Flyrcado brings the first practical opportunity to combine exercise stress testing with cardiac PET imaging for CAD.

Phase I Results for a First-of-its-Kind Macrocyclic Manganese-Based MRI Contrast Agent
GE HealthCare has announced the completion of its Phase I clinical development program for a first-of-its-kind manganese-based macrocyclic magnetic resonance imaging (MRI) contrast agent . The results, which will be used to support ongoing clinical development, concluded that in a first-in-human study, this manganese-based contrast agent was well tolerated with no serious adverse events, dose-limiting toxicities or clinically relevant findings reported. If approved, this agent could provide an alternative to gadolinium-based contrast agents and address the potential impact of post-patient excreted gadolinium in the environment.

Pharmaco-Economic Study Demonstrates Adding Breast Oncology PET Tracer to Standard Workup of Patients with Metastatic or Recurrent Breast Cancer May Yield Beneficial Clinical and Economic Outcomes, Potentially Saving $142M Over Five Years in the US
In a GE HealthCare sponsored pharmaco-economic study published in peer-reviewed journal PLOS ONE , the incidence, prevalence, diagnostic pathways, and treatments of different patients with metastatic or recurrent breast cancer were analyzed using a combination of widely accepted statistical modelling methods to estimate the clinical and associated economic impact of adding a PET/CT scan with [18F]FES, a breast oncology PET tracer, to the current standard diagnostic process. Increased diagnostic accuracy may help clinicians select more effective treatments and decrease the rate of re-biopsies, resulting in the potential cost savings of $142M to the US healthcare system over a five-year period. The study shows that adding a PET/CT scan with the [18F]FES tracer, commercially available in the US as Cerianna™, to biopsy/ immunohistochemistry (IHC) may increase the number of true positive and true negative ER status test results by up to eight percentage points compared to when biopsy/IHC is used alone.

Publication on Artificial Intelligence Models Leveraging Routinely Collected Clinical Data to Predict Patient Response to Immunotherapy
A study of GE HealthCare Artificial Intelligence (AI) models, which have demonstrated the ability to predict patients’ responses to immunotherapies with 70 to 80 percent accuracy based on a pan-cancer cohort, leveraged routinely collected clinical data to accurately forecast effectiveness and toxicities of cancer immunotherapy. Models are designed using data readily available in clinical practice. Due to the broad availability of input features, the models have the potential for wide deployment and adoption. Scalable AI modeling methodology has the potential for use in other care areas such as neurology or cardiology.

MEDIA CONTACT
Emmy Elguizaoui
USCAN Communications Manager
Pharmaceutical Diagnostics
emmy.elguizaoui@gehealthcare.com
M: +1 978 243 7503

INDICATIONS AND USAGE OF CERIANNA™:

INDICATIONS AND USAGE
CERIANNA is indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
Limitations of Use
Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR).
CONTRAINDICATIONS
None.
ADVERSE REACTIONS
In Clinical Trials (n=1207) the most common adverse reactions seen occurred at a rate < 1% were injection-site pain and dysgeusia.
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare Company at 800.654.0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch.

For full Prescribing Information click here.

INDICATIONS AND USAGE OF FLYRCADO™:

Indications and Usage

FLYRCADO is a radioactive diagnostic drug indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction.

Contraindications

None

Warnings and Precautions

• Risk associated with exercise or pharmacologic stress: Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, stroke, and seizure. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent’s prescribing information.
• Radiation risks: FLYRCADO contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to patients and health care providers. Advise patients to hydrate before and after administration and to void.

Adverse Reactions

• Most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia.

For full prescribing information, click here . For important safety information, please click here .