Future Diagnostics: Enabling Optimal Healthcare – Obvious IVD Service Provider

The Silicon Review

In the fast-paced universe of healthcare and diagnostics, human race has made longer strides than possible to imagination. The infusion of cutting-edge technology with healthcare has revolutionized both the fields parallelly. In the highly branched out streams of health, natural and synthesized might be the largest umbrellas the new medical procedures could be grouped under. Talking of synthesized, “in-vitro” is a concept that’s been the talk to the town these days. In-vitro means the study of components of an organism that have been isolated from its natural habitat or surroundings. It could include microorganisms, cells, biological molecules, and many other.

Future Diagnostics are laboratory professionals that are inventing, manufacturing, and certifying in-vitro diagnostic tests and products. While developing an immunoassay, this institution utilizes its tried and tested five-phase New Product Development Process which is accommodating of ISO13485. Throughout all the stages, the advancement of the project is continuously tracking in regards of quality, deliverables, budget, and timelines to schedule and accommodate all the projects. Future Diagnostics is a service-provider and also a development partner to many biotech companies in the global in-vitro diagnostics medical device market. It supports cost-effective healthcare world-wide, provides clients with IVD tests that make all kinds of medical diagnostics possible.

One-of-a-kind Assay Development Services Available

IVD Product Development: Future Diagnostics’ team works to the point of perfection on product development for the detection of biomarkers. This results in a highly professional, high-quality test development in which both the demands of the clients as well as ISO 13485 and FDA regulations are considered. This company’s end product proves that the IVD product development by Future Diagnostics automatically means validated tests that meet the legal requirements for IVD products.

Verification and Validation: Future Diagnostics’ goal is to verify the confirmed assay designs from the examination and provision of objective evidence that informs whether or not the requirements have been met. To help the cause, it produces verification lots using R&D that are standardized against the required design formats. A technical validation and accelerated stability studies of the chosen assay will be performed by the organization.

Point-of-care Test Development: Future Diagnostics is one of the best professional choices when it comes to test development process on the PoC device of the test taker’s choice. It has expertise in whole blood research, dried formulation compositions, and magnetic beads. FD’s clients feel confident and content while working with it as they profit from Future’s knowledge and impeccable know-how.

Companion Diagnostics: Companion Diagnostic (CDx) is a medical equipment, usually used in in-vitro devices, that provides critical information for the accurate and effective use of a corresponding drug or biological component. Therefore, a Companion Diagnostic should identify patients who are most likely to benefit from a therapeutic product; identify patients likely to be at increased risk for serious side effects as a result of treatment with a therapeutic product; or monitor response to treatment with a therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness. Future Diagnostics assists its clientele by designing a personalized CDx for the particular medicine. To make sure that the results are accurate, the lab will also adjust the necessary variables and optimize.

Performance Evaluation Studies (IVDR): The process of evaluating performance studies needs a lot of dedicated time and facilities, along with professionalism and experience. This is where Future Diagnostics steps in. The company, with their expertise, experience, and transparency guides its clientele from the beginning to the end. Depending on the necessity, the lab brings in their sample sourcing team as well. It also offers all the studies of the IVDR, such as analytical sensitivity, analytical specificity, trueness, precision, and accuracy.

Bead Coating Services: Future Diagnostics has over 25 years of experience in the development of immunoassays involving magnetic beads and magnetic bead coatings. It has been able to successfully develop bead-coating processes by diminishing non-specific binding in numerous bead-coating projects for its trusting customers.

DHEAs Antibody: The DHEAs antibody is available through Future Diagnostics. Dehydroepiandrosterone (DHEAS) is the most abundant adrenal androgen in humans and exists predominately in a sulfated form. DHEA sulfotransferase, known as SULT2A1, converts the androgen precursor DHEA to its inactive sulfate ester, DHEAS. The unconjugated molecules can be converted directly to androgens. Dehydroepiandrosterone is converted to DHEAS in the adrenal glands and liver. DHEA in adults is present at plasma concentrations 100 to 500 times higher than those of testosterone.

Lyophilization: It is the process of extracting water from the component to be assayed by freezing it, reducing the pressure, and removing the ice through sublimation. Future Diagnostics makes this process better by developing final lyophilization processes based on the small pilot batches. The process is also optimized and adjusted according to every particular patient’s needs.

Manufacturing: Future Diagnostics is an ISO 13485 certified and FDA registered manufacturing facility, offering small to medium scale pilot and commercial production capabilities. The specific services FD provides are Assembly of full immunoassays (e.g. ELISA, EIA, and CLIA), Reagents (e.g. buffers), and Small scale bead coating, Lyophilization of kit components, also accuspheres, Product filling, Capping and Labeling.

Frank Martel, Managing Director