20/20 Gene Systems' BioCheck: The development of a bioterror detection kit

us of high school chemistry: The kits consist of a small box which contains of a tray containing two test tubes and two wetted swabs. One test tube is labeled “Protein” and the other labeled “pH.” A sample of the suspected substance is collected on the swabs and then each swab is immersed in the test tubes which contain a solution. The solution in the protein detection tube may turn purple after five minutes — but only if protein is present. If the color of the solution in the test tube does not change, the emergency personnel can be pretty confident that there is no bio-terror agent involved. Here we o back to high school chemistry: The solution in the pH tube turns either red, stays colorless, or turns blue depending on whether it is an acid, neutral, or basic substance. The pH test helps first responders to determine more accurately the chemical properties of the substance being tested.

Just to be on the safe side, BioCheck contains a test packet which should be used to confirm that a negative result is not the result of a failure of the test. In the control test, a second swab is added to the protein tube after a negative result. This should cause a purple color to appear and confirms that the kit is working.

Even if BioCheck was ahead of the game relative to what was available in the bioterror detection market, the company wanted to improve the kit in order to make it more sensitive so as to decrease the likelihood of false negatives. This additional development work required funds, and this where CCAT came in. 20/20 Gene Systems submitted an application to CCAT in mid-2004, and in October of 2004 the company was granted nearly $75,000 in product development funding, as well as a market study which was completed in April 2005. The key improvement in the kit had to do with altering the chemical make-up of the solutions so that their sensitivity level would increase almost ten fold to 12 mg. Increasing sensitivity may result in increased false positive results (for example, corn starch contains trace amounts of protein, as do most vitamin and nutritional powders), so the company had to control for that.

First responders, emergency units, and other homeland security outfits are the obvious candidates for using the kits. The CCAT market study showed, however, that there was also a need for the kit in private industry, so the company has begun pursuing this market as well. The private sector still remains a distant second to emergency crews in terms of usage, this market continues to grow steadily. As we mentioned above, there is a reason for it: The fear of bioterror attacks increase — but so also are fake attacks initiated by pranksters. Companies must find ways to tell the difference between a real attack and a hoax in order to minimize work disruptions and economic losses.

-read more about BioCheck at company Web site; and at CCAT Web site; for additional information contact Suzanne Finch at CCAT