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FDA clearance for cystic fibrosis molecular diagnostics test - 24 January 2006
Osmetech plc receives FDA clearance for its cystic fibrosis molecular diagnostics test
Osmetech plc, the international healthcare diagnostics group, has received its 510(k) clearance from the US Food & Drug Administration (‘FDA’) for its cystic fibrosis (‘CF’) carrier detection test and its eSensor™4800 DNA Detection instrument platform. Sales of the instrument and CF test will commence in the first half of 2006 as planned.
James White , CEO Osmetech plc said, ‘Gaining FDA clearance for our first microarray based test developed for our new eSensor™ molecular diagnostics instrument is a major step forward for our Molecular Diagnostics Division and will help to establish Osmetech as a key player in the fast growing molecular diagnostics market. In addition, this FDA clearance helps to validate our microarray technology for routine use in the laboratory.
‘Following the approval of the eSensor™ platform we now look forward to progressing discussions with strategic partners who are looking for cost effective and easy to use instrumentation and consumables to work on other complex assays both in the healthcare and non healthcare markets. The next Osmetech Molecular test targeted for FDA submission will be our CYP 450 pharmacogenomics assay, which is currently in development.’
Background information on Cystic Fibrosis
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.
Enquiries:
Osmetech plc: James White/ David Sandilands 0207 849 6027
Madano Partnership: Matthew Moth/ Mark Way 020 7 378 7033
Notes to editors:
Background on the Molecular Diagnostics Market
Molecular diagnostics is the fastest growth segment of the global diagnostics market with annual growth rates in excess of 20%.
The benefits of molecular diagnostics are that it can provide highly accurate testing, the possibility of earlier detection of infectious diseases and can identify patients with a predisposition for certain diseases such as cystic fibrosis and certain cancers. This provides the facility for earlier intervention of therapy thereby facilitating improved treatment success rates. Molecular diagnostics can also enable physicians to pre-determine drug dosages and monitor the effectiveness of such treatments for individual patients and also aid the avoidance of toxicity or adverse drug reactions.
The two main growth drivers for the molecular diagnostics market are the Human Genome Project and the growth of new technologies providing the opportunity for small and medium sized hospitals to carry out tests within this market. Through the Human Genome Project, over 30,000 genes have been sequenced. Assuming that 5 per cent. of these genes will be of diagnostic significance this would create 1,500 gene based tests.
The molecular diagnostics market today is at an early stage of development and is characterised by expensive first generation instruments which require skilled labour and are reliant on high throughput in order to control costs. The batch testing performed in large laboratories and hospitals precludes the ability to give rapid turnaround times. Whilst the common PCR technology is widely understood Osmetech believes that the products available today do not meet the needs of small and medium sized hospitals.
Three main sub segments account for over 75 per cent. of the US molecular diagnostics market: Human Genetics, Pharmacogenomics and Infectious Diseases.
Human genetics focuses on enabling the physician to test individuals for diseases for which they have a genetic predisposition, for example: cystic fibrosis, thrombosis, Alzheimer's or certain cancers. This is achieved through the detection of SNPs or "mistakes" in an individual's DNA which may cause the mutations that are associated with a particular disease. This is the segment where Osmetech is launching its first products.