I'll try to give some succinct answers to your questions.
what are the advantages of the cst product over the current one.
- Slightly more accurate that the current skin test
- Only one patient visit required - to draw blood for the test. The skin test requires a second visit to read the test. Many readings are never made as patients don't return or get relocated (in jails).
- Complexity. The guidleines for use of the skin test are quite complex as the reading of the size of the unduration (lump) is taken to mean different things depending upon the patients history.
- Subjectivity. The reading of the lump is open to subjective interpretation by the nurse or doctor. QuantiferonTB (the CST test) is a laboratory test that gives a Yes or No answer.
- Results available in under 24 hours as opposed to skin test 48-72 hours (skin tests must be read within that time frame).
- As the skin test is done by injecting a deactivated virus under the skin it itself can actually affect future tests (false positives).
The above all refers to the QFTB1 test which is currently being marketed. The QFTB2 test which will be on the market by October next year has a very significant advantage over the skin test. In some countries (Japan and UK but not US) large proportions of the population have been vaccinated with the BCG vaccine against TB. Whilst this vaccine has been demonstrated to have some limited protection effect in children it has never been shown to provide protection to adults. The skin test (and to a slightly lesser extent, QFTB1) cannot distinguish between TB infection and the BCG vaccine. QFTB2, however, uses a different protein and has been shown to be 100% specific in determining TB infection, as opposed to BCG vaccinated.
will it be cheaper method for the end user or just more effective.
The Quantiferon test will not replace the skin test in all situations. The QFTB requires laboratory resources that are often not available in third world countries. The 1 billion plus tests per year in the third world have NOT been considered at all in the plans QFTB.
All up, in addition to being a more effective test, there have been studies that show that when taking into account the non-returns and mis-readings of the skin test, the QFTB test is cheaper.
are your figures based on the improved product and what is the total western market.
The growth of the sales will commence with QFTB1 in 2003 and continue to grow over future years with both QFTB1 and QFTB2. The company is very specifically marketing QFTB1 at the moment.
The total Western market was originally estimated at around 45m tests (US 10m, Europe 10m, Japan 25m). The US market has since been estimated at 15m, bringing the total market to 50m TB tests per annum.
The US has NEVER used the BCG vaccine mentioned above and therefore this is the companies main initial target market. The company has said that sales of QFTB2 will not take place in the current FY.
QFTB2 is usefull to the US for testing of immigrants, primarily. A recent report has shown that testing of all immigrants for latent TB will save the US up to $90m per year.
Japan is targeted for 12 to 24 months away. Japan has declared TB a national health emergency and has mandated that every employee of every company with more than 50 employees must be tested for TB every year. Because virtually 100% of the population has been vaccinated with BCG the current skin test is of virtually no benefit and a huge number of X-rays are conducted to assist with the diagnosis. Japan have already conducted trials of the QFTB2 test and are very keen to get this test. IMHO, the penetration of QFTB2 into Japan will be fast and massive. This is a target market of 25m tests per year.
Domain, I hope that the above is of help.
One final thing. The future. Whilst the company is concentrating primarily on TB at the moment, the Quantiferon technology has uses in other tests, including Lymes disease and leprosy. These are futuire strings to our bow.
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