Quantify Amyloid Burden with Confidence

Quantify Amyloid Burden with Confidence

Quantification – FDA Approved with Neuraceq®

Why Quantification Matters in Today's Evolving Diagnostic Landscape

  • Quantification with Neuraceq® offers an objective measurement of β-amyloid plaque burden, supporting clinicians in the evaluation of patients with cognitive impairment.1
  • As an adjunct to visual interpretation, quantitative data enhances diagnostic confidence — particularly in cases with subtle uptake.2
  • Quantification may aid in identifying patients eligible for amyloid-targeting therapies.1
  • By providing a reliable, objective assessment of amyloid burden1,3, quantification can support evaluation of disease across various stages of cognitive impairment and dementia.2

Quantification can enhance diagnostic confidence, particularly in intermediate patient cases3

Note: the 20-35 range (the region between the yellow lines) is considered “intermediate.”

Jovalekic, A., Roé-Vellvé, N., Koglin, N., Quintana, M. L., Nelson, A., Diemling, M., Lilja, J., Gomez-Gonzalez, J. P., Dore, V., Bourgeat, P., … & Bullich, S. (2023). Validation of quantitative assessment of florbetaben PET scans as an adjunct to the visual assessment across 15 software methods. European Journal of Nuclear Medicine and Molecular Imaging, 50, 3276–3289. https://doi.org/10.1007/s00259-023-06279-0

  • ≥35 CL: Strongly associated with established amyloid pathology and moderate to frequent neuritic plaques.

  • <20 CL: Common in cognitively normal elderly patients, typically corresponding to negative amyloid PET scans.

  • 20–35 CL: In these intermediate patient cases, quantitative analysis can provide valuable clarity by highlighting subtle, focal, or unilateral amyloid deposition.

    • Readers should review such scans carefully to identify subtle amyloid accumulation that can be focal and/or unilateral (see the red arrow on the figure for reference)

To complement visual reads, several FDA-cleared software options are available for amyloid quantification with Neuraceq®. These solutions can help ensure more consistent and reproducible assessments in clinical practice, and include the following:

NeuroQ™ 3.8

510(k) K180077 on FDA database; NeuroQTM is a trademark of Syntermed

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Neurophet SCALE PET

510(k) K221405 via FDA listing; Registered to / owned by Neurophet, Inc.

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cNeuro® cPET

510(k) K231576 via FDA documentation; Registered to / owned by Combinostics Oy

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syngo.via MI Workflows (Scenium®)

510(k) K242275 via FDA summary; Registered to / owned by Siemens Medical Solutions USA, Inc. / Siemens Healthineers

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MIMNeuro®

510(k) K233620 via FDA summary; Registered to / owned by: MIM Software, Inc.

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HERMES BRASS™

510(k) K140269 via FDA; Registered to / owned by Hermes Medical Solutions AB

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All trademarks, logos and brand names are the property of their respective owners. All company, product and service names used above are for identification purposes only. Use of these names, trademarks and brands does not imply endorsement.

Enhance Your Confidence in Amyloid PET Interpretation

The Neuraceq® Reader Training course now includes an optional quantification module.

*Use the Branch Code FBBReaderTraining if you are not currently registered.
START THE TRAINING

For more information or questions surrounding Quantification with Neuraceq®, contact Your Neuraceq® Representative. 

For technical information on quantitative analysis, visit Contact Us and select “Medical Affairs” under Inquiry Type. 

References:
  1. Neuraceq® (florbetaben F18 injection) prescribing information. Life Molecular Imaging; June 2025. Fareham, UK.
  2. Collij LE et al., J Nucl Medicine 66(1)110-116. (2025). Link: https://pubmed.ncbi.nlm.nih.gov/39542700/
  3. Jovalekic A et al., Eur J Nucl Med Mol Imaging 50:3276-3289. (2023). Link: https://pubmed.ncbi.nlm.nih.gov/37300571/

Neuraceq® - Product Indications And Use

PRODUCT INDICATIONS AND USE: NEURACEQ is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for:  Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline, and selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products.

 

NEURACEQ IMPORTANT SAFETY INFORMATION:

 

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

  • Risk for Image Misinterpretation and other Errors
    NEURACEQ Risk of Image Misinterpretation and Other Errors: Image interpretation errors have been observed. [see Section 5.1 of the full prescribing information]
  • Radiation Risk
    NEURACEQ, similar to other radiopharmaceuticals, 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 protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration in the full prescribing information].

ADVERSE REACTIONS:

  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/application site erythema (1.7%), and injection site irritation (1.1%).

USE IN SPECIFIC POPULATIONS:

  • Pregnancy : All radiopharmaceuticals, including NEURACEQ, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering NEURACEQ administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
  • Lactation : Temporarily discontinue breastfeeding. A lactating woman should pump and discard breast milk for 24 hours after NEURACEQ administration.
  • Pediatric Use:  The safety and effectiveness of NEURACEQ have not been established in pediatric patients.
  • Geriatric Use: No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger adult subjects.

OVERDOSAGE:
 In the event of administration of a radiation overdose with NEURACEQ, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to NEURACEQ administration, please read the full Prescribing Information for additional Important Safety Information.

SUSPECTED ADVERSE REACTIONS: please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

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