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Osmetech plc is an international healthcare diagnostics group with two divisions: Molecular Diagnostics and Critical Care, based on the OPTI range of blood gas and electrolyte analysis products.
Osmetech Molecular Diagnostics has launched its eSensor Cystic Fibrosis Carrier Detection (CFCD) test and its eSensor 4800 DNA Detection instrument at the American College of Molecular Genetics meeting in San Diego, US, on 23-26 th March. Product shipments are expected to commence on schedule during the first half of 2006.
The eSensor instrument and proprietary consumable system was developed by Clinical Micro Sensors, Inc. (CMS) which was acquired from Motorola Inc. in July 2005.
The eSensor system has the capability to perform relatively complex molecular tests that require the simultaneous analysis of multiple genetic information. Combining a universal platform design and a patented advanced electrochemical detection technology, the eSensor System can detect and identify many different targets at once.
The technology is protected by a strong intellectual property portfolio comprising over 70 worldwide patents and has benefited from an investment of over $100m by Motorola during their period of ownership.
In January 2006 Osmetech received 510(k) clearance from the US Food & Drug Administration (‘FDA’) for its eSensor CFCD test and its eSensor 4800 DNA Detection instrument platform.
This FDA approval is a first for a combined instrument and Cystic Fibrosis assay consumable which incorporates a microarray with electrochemical detection. The system qualitatively assesses the carrier status for Cystic Fibrosis for all adult couples contemplating pregnancy.
In clinical trials, studies were conducted using the eSensor CFCD System compared to bidirectional DNA sequencing. The method comparison studies tested a total 486 samples. The eSensor CFCD system concordance with sequencing was 98.6% following repeat testing of samples which gave no-call, or 99.6% for samples which gave a valid result. The comparison study analyzed 11,178 individual mutations. For all mutations the percent agreement between the eSensor CFCD system and sequencing was 99.0% following repeat testing of samples which gave no-call or 99.98% for samples which gave a valid result.
The combined instrument and microarray consumable is the platform which is being used for future assay development. The next molecular diagnostics tests targeted for FDA submission will be for CYP450 which will provide pharmacogenomic information for better patient care and improved healthcare cost management.
‘We are delighted to have achieved this important milestone with the launch of the eSensor CFCD system at the American College of Molecular Genetics meeting in San Diego. This is another important step in the controlled market release of our first product to the molecular diagnostic laboratories.
‘In the first 8 months of ownership of CMS, Osmetech has secured the first FDA approval for the eSensor product and also obtained an FDA California State License to manufacture product. The eSensor has now been launched and shipments should commence on schedule during the first half of 2006.
‘We are building on this excellent progress by continuing discussions with strategic partners who are looking for cost effective and easy to use instrumentation and consumables to work with other assays both in the healthcare and non healthcare markets.
‘We expect to be able to further demonstrate the considerable value within our molecular diagnostics products and intellectual property portfolio in due course.’
Osmetech plc: James White, David Sandilands 020 7849 6027
Madano Partnership: Matthew Moth, Mark Way 020 7593 4000
- With a carrier frequency of one in 25 and an incidence of one in 2,500, Cystic Fibrosis is the most commonly inherited disease in the North American Caucasian population.
- The American College of Medical Genetics and the American College of Obstetricians and Gynaecologists recommended in 2001 that Cystic Fibrosis carrier testing should be made available for all reproductive couples.
- Currently around one million tests are carried out annually in the US alone.
- Most current tests are not FDA approved and testing locations are restricted to those 300 institutions which are CLIA approved for running complex testing where the testing institution is responsible for regulatory obligations rather than the diagnostic company.
- The tests carried out in the large central laboratories are performed on instruments that can cost in the region of US$100,000 and a high throughput is required to justify the capital cost of the equipment.
- In addition the instruments are operated by qualified technicians capable of interpreting the results.
- As a result of this each test is relatively expensive with each test recharged at up to US$400 per test to those small to medium sized hospitals requesting the tests to be run on their behalf.
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