DST earns prestigious Australian TGA Regulatory Approval for RAPID Allergen Test Schwerin
DST Diagnostische Systeme und Technologien GmbH (DST GmbH), a leading German medical device manufacturer and exporter, is pleased to announce that it has received approval from Therapeutic Goods Administration (TGA), Australia, for its new Fast Check POC 20 Allergy Rapid Test. DST GmbH is the first company to receive regulatory approval for this type of diagnostic device from the Therapeutic Goods Administration (TGA), Australia.
With an overall healthcare spending market of around US 12 billion dollars, Australia is one of the richest healthcare markets in the Asia-Pacific region and the 13th largest in the world. Allergies are an extensive and rapidly growing problem affecting up to 30%- 40% of the Australian population and, if untreated, can lead to severe diseases such as dermatitis, rhinitis, gastric problems, asthma and anaphylaxis. The FastCheckPOC® 20 is an innovative new diagnostic test system for the identification of allergens amongst Australian patients. With its inherent advantages of speed-of-result, convenience and easy availability, it is a valuable alternative to traditional skin prick testing and laboratory-based specific IgE tests which are the two most commonly used methods for confirming allergen sensitization.
The Therapeutic Goods Administration (TGA), a division of the Australian Department of Health and Ageing, is the regulatory body responsible for conducting assessment and monitoring activities to ensure that therapeutic goods (including medicines, medical devices, gene technology, and blood products) available in Australia are of a high standard. Under Mutual Recognition Agreements (MRA), TGA’s Certificates of Compliance are recognized by over 20 developed countries.
DST GmbH is a company that develops, manufactures and markets in vitro tests for point of care diagnostics as well as ELISA based test systems. DST has committed itself to high user friendliness and excellent reliability. DST GmbH is amongst the leaders of the German medical device manufacturing industry and has been setting new trends in Point of Care and IVD Allergy diagnostics as well as in exploring new horizons of export opportunities. Obtaining regulatory approvals in Australia and Europe, and completing enrolment in our Australian clinical study, demonstrate that DST GmbH is moving forward aggressively in achieving key milestones as we prepare for launch in other key markets around the globe.
DST is bringing a simpler and gentler procedure to allergy diagnostics to enable medical professionals to intervene earlier in the allergy disease continuum, which has the potential to dramatically improve patients’ quality of life around the world. Major products of the company are tests based on the FastCheckPOC® platform that require only minute amounts of capillary or heparin blood. These tests come as complete kits and do not require any further equipment or readers. The test result becomes visible as an unambiguous patented display after max. 30 minutes. DST’s FastCheckPOC® allergy tests screen specific IgE against multiple airborne or food allergens, respectively, and cover 90% of the relevant allergies.
Furthermore, DST also offers s-IgE and s-IgG4 based liquid allergen diagnostic systems for manual or automated laboratory testing. DST is ISO 9001 and ISO 13485 certified and the test is CE-marked.