In collaboration with four partners from the pharmaceutical industry, TNO aims to develop a sensitive AMS (Accelerator Mass Spectrometer) method for the generic detection of drug compounds present in human matrices and hereby  aimed to speed up drug development by conducting label-free mass balance studies rather than 14C-labelled compound.

For registration of new small molecule drugs, human mass balance studies are required to substantiate that the fate of the drug is thoroughly understood. These mass balance studies, normally executed with 14C labelled drugs, are high cost studies and are therefore generally in the critical path to registration. However, a labelled drug is not necessary for all commercially available drugs. For a specific selection of compounds under development it is possible to execute mass balance studies without any additional label, and suddenly for these drugs, any human clinical trial would become potentially a human mass balance study. This would save a tremendous amount of costs and time, and, more importantly, this would take the human mass balance study out of the critical path. Time to market would be shortened by up to one full year.

Within this project, the partners investigate the possibility to analyse drug compounds, that meet the criteria for this innovative approach, in physiological fluids (urine, plasma, faeces) in the low pg/mL range by Accelerator Mass Spectrometer (AMS). Currently there are no generic analytical techniques available that could provide mass balance data directly from any clinical trial with unlabelled compounds.

This project will result in a proof of concept, for both technical (AMS tuning) and analytical (sample preparation) aspects. If successful, it will result in generic methods, qualified  according to European guidelines, which can be used in clinical studies.

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The data show that high breast volume and low compression pressure are associated with positive performance measures such as lower recall rate and higher specificity (true positive) of tumor detection. Procedures with too low pressures result in unnecessary recalls due to false positives. Flattening of the breast on the basis of pressure, also prevents unnecessary discomfort and pain, which may contribute to a higher breast cancer screening compliance of women. The Sigma pressure technology aims to optimize these three elements.

Sigmascreening’s Sensitive Sigma Paddle is the first pressure based compression paddle providing real-time and reproducible information on mammographic pressure, which can considerably reduce frequently experienced pain for women during screening. It optimizes compression for every individual breast, taking into account breast size and tissue stiffness, which leads to an optimal mean contact pressure per woman thereby optimizing both specificity (true negative) and sensitivity (true positive) for the most optimal screening result.

Sigmascreening’s pressure-standardized breast compression is expanding rapidly in screening centers and hospitals throughout Europe. In Europe, over 10,000 patients already experienced the more  woman-friendly way of making mammograms while clinicians are starting to recognize the improved sensitivity and specificity of our technology. The Sensitive Sigma Paddle with CE marking is already being used in the United Kingdom, Norway, France, Germany, Sweden, The Netherlands, Belgium and Switzerland.

Source: Sigmascreening