in Vitro Diagnostics Experience
For over 40 years ITL has been heavily involved in the development, design and manufacturing of a number of in vitro diagnostic (IVD) devices.
In that time we have seen the market for IVD devices evolve and have worked alongside the companies that have pioneered some of the in vitro diagnostic techniques that are now taken for granted.
Here are some of examples of the IVD projects that ITL has been a part of:
In the 1980s ITL developed a very successful range of single and multi-well Gamma counters for radioimmunoassays.
One of these counters was developed and manufactured on an OEM basis for Diagnostic Products Corporation (DPC) - now a subsidiary of Siemens Medical Solutions, following acquisition in 2007.
Enzyme Linked Immunosorbent Assay (ELISA)
As radioimmunoassay was slowly superseded by automated enzyme linked immunosorbent assay (ELISA) in the 1990s ITL became involved with developing bespoke instruments which combined multiple reagent storage at 4oC with enzyme reactions running at 37oC.
These instruments contained elaborate software suites able to schedule runs of batches of panel tests, incorporate random access for additional tests and accommodate a stat test for that one sample that the consultant needed right away.
The engineering task of developing this type of instrument was complex and included throughput expectations for a range of tests and patient samples, patient sample tracking, Laboratory Information Management System (LIMS) communication and database management requirements.
Physical parameters like fluid volume dispensing and aspiration accuracy and precision, temperature tolerances, sample and reagent carry-over requirements alongside the accuracy and precision of movement mechanisms all had to be determined.
Working for companies such as Kodak Clinical Diagnostics and Organon Teknika, ITL has developed high performance colorimetric, fluorometric, luminometric and electrochemical readers - among others.
Clinical microbiology, which has been described as the last bastion of bioscience laboratory automation, has also featured in ITLs long and varied history.
For clients including Sanofi Diagnostic Pasteur (SDP) - Now BioRad, ITL has worked in the key areas of automation such as bacterial identification and antibiotic susceptibility testing, including Minimum Inhibitory Concentration (MIC) determination.
In a similar way to IVD devices as they progress towards Point-of-Care (POC), sample collection devices have been pivotal for microbiology automation.
These devices can be simple collection devices, or they can be complex devices that contain all the reagents necessary for the test.
This approach was used in our design of the World’s first automated DNA diagnostic instrument that detected Tuberculosis for Gene-Trak Systems (above).
The patient sample was introduced into the disposable by a clinician and was loaded manually into the instrument. Everything from the introduction of reagents at various stages of the test to incubation was then automated until the final result was fluorimetrically read and the result presented to the clinician. All of this took place in a sealed cartridge that could be safely disposed of after the test.
Plasmid DNA Purification
Developed by ITL in 2002, the T-1000 was Tepnel’s first automated DNA purification system.
The system is used within the Pharmaceutical and Biotechnology industries to prepare high quality DNA to be used with DNA sequencing systems.
Point of Care IVD Tests
Being able to provide a diagnosis from a patient sample without sending it to a lab for analysis has clear benefits for both patients and healthcare professionals.
Products such as the Vivacta Point-of-Care testing system, which was spun out by ITL and later sold to Novartis for $90m, are a prime example of this.
Related Article (directs to ITL USA website): Product Development for Point-of-Care Testing Systems by ITL Virginia Inc.
Polymerase Chain Reaction (PCR)
As PCR has got more sophisticated and incorporated real time reading, ITL re-developed an existing PCR machine to be able to read real-time PCR on 96-well microplates.
To keep costs low, this involved developing a sophisticated heated lid for the microplates which could be read through using multi wavelength flourimetry coupled to a novel low fluorescence fibre optic system.
We have also designed several IVD devices that used PCR for DNA amplification for later diagnostics.
One example is our development project for elements of the QuantuMDx Q-POC who have the goal of eventually developing a handheld DNA analyser for 15-20 minute disease diagnostics at the patient’s side.
Molecular Diagnostics and Next Generation Sequencing
In recent years DNA Sequencing and molecular diagnostics have become easier and faster and are now tipped to be the next big thing in diagnostics.
ITL are involved with clients at the forefront of these technologies, for example the Genomic Vision automated scanning and image analysis system for which ITL is a major product development and manufacturing partner.
ITL has also manufactured a number of products for a next generation sequencing pioneer.
This vast engineering experience gathered over many years, along with a strong grounding in biochemistry, separates ITL from the competition.
Couple this with a strong regulatory understanding, in-house laboratories and full ISO 9001, ISO 13485 and FDA approved manufacturing and it becomes clear why ITL has been the predominant company in outsourced IVD instrument design and manufacturing over many years.