Zila to be Issued Additional U.S. Patent for OraTest(R) Diagnostic Kit

March 20, 2002
New patent complements cutting-edge line of oral cancer detection products.

Zila, Inc. (Nasdaq: ZILA), international provider of healthcare and biotechnology products and services for dental/medical professionals and consumers, announced it has received a
Notice of Allowance from the U.S. Patent Office advising that the agency will issue an additional patent relating to the Company's OraTest(R) oral cancer detection product.
The patent will have claims protecting: 1) a "method" for screening patients for oral epithelial cancer, requiring the use of at least two liquid testing solutions applied sequentially, one of which is a "staining dye reagent" and the other of which is "a rinsing reagent", the key feature being that the staining dye is contained in a separate package, with a preselected dye volume and concentration; and 2) a diagnostic "kit" for screening to
detect oral epithelial cancer, with a separate package of the staining dye reagent included in the kit.
"An important feature of this patent," said Doug Burkett, PhD, Zila Group Vice President, "is that it covers the use of any 'staining dye' in such a kit. While the OraTest product, as presently constituted, features the active ingredient Zila(R) Tolonium Chloride, this patent covers, but is not limited to using that particular staining dye."
Dr. Burkett noted that the new patent will complement Zila's 15 other issued or pending U.S. OraTest and Zila Tolonium Chloride technology patents.
Patents corresponding to all 16 U.S. patents have either issued or are pending in other countries.
OraTest rinse and swab products are the subject of an on-going Phase III clinical trial in the U.S., being managed by ILEX(TM) Oncology Services. Zila recently announced it has appointed World Medical Trade Organization, Inc. (WMTO) as distributor of Zila's ViziLite(TM) disposable chemiluminescent oral examination kits and OraTest oral cancer detection products in major Asian