On 20/01/05 CST lodged a patent for its In-Tube system which...

On 20/01/05 CST lodged a patent for its In-Tube system which will provide protection for both QFTG and the Quantiferon Platform until 2021. Thus CST has ample time to develop new diagnostics for its Quantiferon Platform.
So now the patent is secure until 2021.


Any new diagnostic will also have its own particular patents further extending the patent life for the particular diagnostic.

In-Tube consists of placing the blood directly into a tube which contains the antigens separated by a gel. The tube is then shaken and the blood and antigens mix. The In-Tube system “renders the assay far more sensitive” due to the immediate incubation of the blood, the additive response due to the antigens in one tube, and in the case of QFTG, to the addition of an extra antigen TB7.7.

For a patent to succeed it is measured against the “state of the art” and an assessment is made regarding whether the invention described in the application is “new, not obvious and useful”. Newness in this sense is judged in relation to what was publicly known or used at the date of the application. Newness also involves the requirement for a distinct inventive advance over what was previously known. Patent protection cannot be obtained for obvious developments.
Military: The US military is estimated to account for 1.5 million tests per annum.

For logistic reasons the military proposes to only use QFTG-IT. In preparation, QFTG (not In-Tube) is being used at Tripler Army Medical Center, Hawaii; In-Tube implementation and automation is underway at Brookes Air Force Base, Texas.

Brookes can run up to 20,000 tests per day and would like to become the central processing unit for the entire US Military.

Automation involves the USAF writing software and trialling an automated ELISA reader (Tritirus Instrument) which has the capacity to significantly reduce the manpower and time requirements for processing mass QFTG-IT tests. The USAF anticipates that this effort should result in enabling a new defacto standard for TB testing with worldwide application in military and civilian sectors.