Parathyroid hormone (PTH), which is produced by the parathyroid glands, is cleared from the blood stream quickly. Within a 10 minutes of removing the hyperactive parathyroid tissue, the PTH levels fall by more than a half.
By testing intact-PTH levels before removing the hyperactive parathyroid glands and again after removal of the abnormal gland the surgeon can determine if sufficient tissue is removed. For a successful operation surgeons look for at least a 50% drop in the PTH levels in order to consider the parathyroidectomie a succes.
The STAT-IO-I-PTH system of Future Diagnostics is an unique aid in monitoring the intact PTH levels during parathyroidectomies. The system is designed to be; mobile, simple and provide test results fast.
It is our solution to contribute to the performance of your hospital and the efficiency for surgeons
Our free 25OH Vitamin D ELISA is a CE-IVD marked, competitive ELISA two-step immunoassay. It allows a direct measurement of the concentration of free 25OH Vitamin D in serum. The assay is calibrated against a symmetric dialysis method. Above all, it shows excellent sensitivity, precision and as well as performance characteristics, as performed according to the CLSI guidelines.
This assay is the result of a collaboration between DIAsource ImmunoAssays S.A. and Future Diagnostics Solutions B.V. Future Diagnostics developed Vitamin D assays showing the highest grades of specificity, sensitivity and precision found in the market for large multinational IVD companies. Diasource develops, manufactures and markets clinical diagnostics products and is committed to Vitamin D, including IVD and RUO products. Future Diagnostics filed a patent for this assay, whereas DIAsource ImmunoAssays has the exclusive rights for commercialization of this ELISA assay.
IVD ASSAY DEVELOPMENT & CONTRACT MANUFACTURING SERVICES
Future Diagnostics Solutions offers in vitro diagnostic (IVD) assay development and contract manufacturing services to start-up companies, mid-sized biotech and IVD multinationals within the global IVD medical device market. With more than 20 years of experience, 150 IVD product developments and over 50 highly experienced employees, we are dedicated to make any developments, or different phases within the development, successful.
The profound experience makes us a trusted partner for assay development of any type of immuno assay or chemistry test with any type of technology, on any type of analyzer, across any type of disease area.
In general, development and manufacturing in IVD faces challenges resulting from:
• Globalization of operations and supply chains • Pressure to deliver products to the most cost-effective manner possible • The need to bring new concepts to market at an ever-faster pace • Increasing customer expectations for superior quality
These challenges support the need for high level quality management. Future Diagnostics is ISO 13485 certified and integrates its Quality Management System and Design Control Standards within every assay development and manufacturing project. We work according to the needed harmonized standards, EN 13612:2002, EN ISO 23640:2015 and applicable CLSI guidelines.
Future Diagnostics has small to medium scale pilot and commercial production capabilities conform the cGMP requirements for 21 CFR part 820. The manufacturing site is FDA registered (FDA inspections in 2004, 2008, 2011 and 2016).
The customer will be involved during the whole project and will have calls with our experts on a regular basis. They will be updated on technical status, timelines and feedback is given, when needed. In addition, the customer can follow the progress of the project in real time on our SharePoint platform. They can log in onto the secured SharePoint system to review all data that has been produced.
For IVD registration of a product a technical file needs to be set up in compliance with the medical device regulation from a specific country. Future Diagnostics will write a part of the technical file that is needed for the legal registration. The customer will be the legal owner and legal manufacturer of the product. The product will only show the name of customer.