Technopath Clinical Diagnostics is an Irish company driven by innovation with a mission to become the global leader in test-consolidated third party quality control materials and real time peer review software solutions. We aim to support clinical laboratories to operate more efficiently while improving the quality of patient test results.
We operate in the high growth in vitro diagnostics (IVD) sector. Our business is focused on three core elements:
- Human based quality control material for clinical laboratories – Multichem
- Quality control software and data management solutions – IAMQC
- High quality IVD raw materials – IVD Raw Materials
Founded in 2004 – Technopath Clinical Diagnostics has a track record of achievement driven by our customer focus. We constantly challenge ourselves through our products to improve the efficiency, compliance and cost effectiveness of clinical laboratories while improving the accuracy and quality of patient test results.
|Founded in Ireland||2004|
|Launched Multichem product range in Ireland and UK||2008|
Achieved ISO 9001:2008/13485 accreditation||2008|
|Signed global supply agreement with Abbott Diagnostics for Multichem product range||2012|
US FDA 510k product approval for Multichem product range||2013|
Global product launch of Multichem||2014|
China SFDA approval for Multichem||2015|
Achieved Multichem product range sales in over 100 countries ||2015|
Launched 3 new Esoteric QC products||2015|
Acquired technology and IP related to our IAMQC informatics platform providing enhanced control of future development||2015|
Commenced major capital investment program to expand manufacturing capacity||2015|
We operate in the global IVD market and according to a report by Frost & Sullivan (1) “IVD markets are growing robustly at double the rate of the global pharmaceutical industry. The global IVD market size was $47.30 billion in 2013; it is expected to reach $62.63 billion in 2017, at a compound annual growth rate of 7.3%”. This growth is driven by demographics (ageing populations); increasing focus on prevention and early detection of disease, the rise of evidence based medicine and strong growth in emerging markets such as Brazil and China.
(1) Frost & Sullivan - Analysis of the Global In Vitro Diagnostics Market – July 2014
Multichem – a leading third party test-consolidated quality control
Laboratory quality control is focused on reducing deficiencies in a laboratory’s analytical processes prior to releasing patient test results and allows an overall assessment of how well a laboratory is performing over time and under varying operating conditions. Laboratories typically run quality control material on a daily basis and when there are changes in their environment such as after equipment servicing, changes in reagent lots or when patient results seem inappropriate. There are many elements to laboratory quality control including the use of quality control material such as Multichem and peer review software such as IAMQC.
Quality controls are classed as medical devices as they are used as a component with diagnostic tests. A third party control is deliberately not optimised to work with any specific instrument or reagent system. Technopath Multichem test-consolidated controls all have a human based matrix that helps provide a product that mimics a patient sample. These controls are intended to be used for performance monitoring of specific lists of analytes on automated analyser platforms.
Multichem was developed based on our deep science and proprietary technology which allows the inclusion of multiple analytes in our product and provides a unique level of test consolidation. For example our Multichem IA product includes over 100 analytes. Multichem’s uniquely stable and flexible base matrix facilitates the addition of new markers as and when the market requires, which contributes to the strength of the test-consolidated Multichem brand.
Multichem, a patient like material which is liquid and stable, contains known concentrations of analytes and a range of analyte values with upper and lower limits that closely mimic a patient sample at relevant clinical decision points. Where a QC test result falls within those limits a laboratory can have confidence that their system is working properly and patient test results may be reported with confidence.
Multichem provides significant benefits to laboratories:
- Class leading test-consolidation (multiple analytes) minimising the range of QC materials required (Our two flagship products Multichem IA+ and Multichem S+ replace six of our main competitors products);
- Third party control independent of equipment and reagent kit manufacturers;
- Commutability across all diagnostic platforms;
- Performs like a patient sample;
- Meets accreditation and compliance guidelines; and
- Significant operating efficiencies for laboratories – less labour, less inventory, less waste disposal and more analytes.
IAMQC Software and Data Management Platform
Technopath Clinical Diagnostics IAMQC™ real time cloud based software platform is an automated QC data management tool which allows users to automate, centralise, standardise and improve QC processes in a laboratory setting while addressing laboratories interlab/peer comparison needs. It has powerful QC troubleshooting tools and automates important accreditation and compliance records. IAMQC™ has links to all major equipment platforms which automates the tedious and error prone work of manually transcribing QC test results. Using a Software as a Service (SaaS) model there are no hidden hardware or installation costs.
IVD Raw Materials
We develop and manufacture high quality raw materials for IVD manufacturers on both a custom and off-the-shelf basis. Products include Human Plasma, Normal Human Serum, Lipoproteins and Immunoproteins. Our customers typically incorporate these raw materials into their reagent kit manufacturing processes.
Research and Development
We invest significantly in research and development focused on our core base matrix technology and developing new products to meet our customers needs – whether for the automated analyser platform or focused point of care (POC) testing equipment. Our unique technology platform has facilitated our class leading test-consolidated Multichem product range which is unmatched in our industry. Our experienced R&D team comprises highly qualified scientists with a constant focus on delivering industry leading solutions. For more informations see – Research and Development.
Quality and Manufacturing
As a quality driven organisation certified to ISO 9001:2008/13485 we develop and manufacture all of our products in our dedicated state of the art modern facilities at Technopath Life Sciences Park, Fort Henry, Ballina, Co. Tipperary, Ireland. Our products are sold in over 100 countries globally and approved by regulatory agencies including US FDA and the Health Protection Regulatory Authority Ireland.
Every day we are committed to delivering high quality, safe and effective clinical diagnostic products to achieve maximum customer satisfaction by complying with the appropriate regulatory requirements supported by our Quality Management System.
We recently commenced a major expansion of our capabilities including a capital investment program to greatly increase our manufacturing capacity to meet growing demand for our products and significant investments in new product development to meet customer demands.