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Frequently Asked Questions
1. What is the AmpliChip CYP 450 test?
The AmpliChip CYP450 test is the world's first diagnostic test for personalised care.
The test can help doctors identify the best treatment options for a patient and subsequently provide better treatment for patients with chronic illnesses associated with cardiovascular diseases, psychiatric disorders, pain relief and cancer.
2. What is 'personalised care'?
We aren't all the same on the outside or on the inside - doctors know that some patients don't experience the same benefit from one drug that may treat another patient successfully with the same disease or condition.
3. What is 'pharmacogenetics'?
Pharmacogenetics is the study of how a patient's genetic makeup can influence their response to a drug. It helps doctors to better predict how a patient will respond to specific medicines.
4. What does CYP450 mean?
Cytochrome phenotype 450 (or CYP450) is a family of genes found in almost all living creatures on earth. It is estimated that these genes, which play a primary role in metabolism, have been in existence for more than 3.5 billion years.
In humans, enzymes encoded by the CYP450 genes are found primary in the liver, where they metabolise drugs, toxins and other foreign substances that enter the body.
5. Why has Roche Diagnostics developed the CYP450 test?
Roche Diagnostics has launched this test because there is a definite medical need. Many people will now be able to personalise their medication according to their genetic profile and therefore may receive better, more effective, treatment.
6. Why will the AmpliChip test be useful for patients?
The results help healthcare professionals predict a patient's response to a drug so they can prescribe more accurate doses and minimise a patient's potential bad reaction (or 'adverse drug reaction') to a particular medicine.
7. What is an 'adverse drug reaction'?
An adverse drug reaction (ADR) is an unintended reaction to a drug taken at a normal dose to prevent, diagnose, or treat disease or injury.
Over 280,000 UK patients are admitted to hospital each year as a result of a bad drug reaction and it estimated that up to 10,000 of these will die - AmpliChip CYP450 aims to provide better treatment for:
a. up to 30% of suitable cardiac patients
b. up to 50% of patients undergoing psychiatric treatment
8. Will patients be able to get this test performed in the UK?
The AmpliChip CYP450 has received approval from the US regulatory authorities, the Food & Drugs Administration (FDA) and from the European regulatory authorities it has received its CE Marking.
Currently in the UK, AmpliChip CYP450 is being used on a research level at the MRC SGDP Centre at the Institute of Psychiatry (IOP) but is not yet available on the NHS.
9. What does AmpliChip CYP450 test for exactly?
The CYP 450 test measures the extent of genetic changes which occur in each individual. The extent of these changes tells the person and their clinician how they will respond to drugs which use these two (CYP 2D6 and CYP2C19) pathways.
10. What sort of diseases will the test help to treat?
Up to now, the main usage of the CYP450 test has been in the treatment of psychiatric illnesses. Roche Diagnostics UK is now broadening the applications into the areas of certain cancers (i.e. Leukemia) and heart disease.
AmpliChip Leukemia and AmpliChip p53 promise improved patient management and quality of life with a faster, more specific approach to treatment.
11. How is the test performed?
It is a simple blood test, just as you would expect at your GP's surgery. The test is performed by taking a simple blood sample from the patient, which is then sent to a specialist laboratory for analysis using the AmpliChip technology.
12. Where is it available for public use?
Currently the test is not routinely available in the UK via the NHS. The manufacturers, Roche Diagnostics, are working with the MRC SGDP Centre at the Institute of Psychiatry (IOP) with a view to making the test more widely available to the general public.
13. How much will it cost to have a test?
The cost of the test will be determined by the laboratory conducting the procedure. We envisage that it will cost in the region of £500 at present.
14. Who will pay for the test?
Test funding will come from PCTs and, in some instances, the patients themselves.
15. What are the benefits of getting tested?
The results can help healthcare professionals predict a patient's response to a drug so they can prescribe more accurate doses and ensure that adverse reactions are reduced or avoided completely wherever possible.
The patients themselves can feel more confident about the effectiveness of their medication early on in their treatment, which will contribute to a positive result in the long term.
16. How many people might benefit from knowing their CYP450 status?
In cardiovascular disease and some cancers, between 10% and 30% may benefit from knowing their 'metaboliser status', depending on ethnicity and treatment regime. In psychiatric disorders and pain relief, between 20% and 50% of patients could benefit depending on ethnicity and treatment regime.
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