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Infectech Registers Identikit Test Kits With FDA and Can Begin Selling Line of TB and Non-TB Bacteria Testing Products

Posted on: Tuesday, 1 February 2005, 09:00 CST

SHARON, Pa., Feb. 1 /PRNewswire-FirstCall/ -- Infectech, Inc. (Pink Sheets: IFEC), a biotechnology company engaged in research, development and commercialization of technologies for the production of bacteria and disease testing kits, alternative sources of fuel and remediation of toxic materials, today announced that it has received notification from the U.S. Food and Drug Administration Center for Devices and Radiological Health ("FDA"), of registration of the company and its initial product line for biophasic system devices. Because it was categorized as a medical device that did not require the standard lengthy FDA approval process, Infectech intends to begin the production, marketing and commercializing of its biophasic system devices to cultivate and identify certain pathogenic microorganisms for medical purposes.

Infectech's Indentikit product line was developed for the rapid identification and antibiotic testing of disease-causing pathogens. The basic test kit consists of a glass slide coated with paraffin, which is used as a carbon (food) source by certain bacterial species. The slides are incubated in a sample of almost any bodily fluid (a non-invasive sample of saliva is preferred) within a nutrient broth. This creates a semi-solid growth medium for the bacteria, which imitates its natural environment within a human or animal host. The bacteria collect on the paraffin slide in 4-8 days. Testing can then be done to identify the species of bacteria. This testing can be done via acid-fast staining or through PCR gene amplification. Additionally, the bacteria can be cultured with antibiotics to test for specific sensitivities. Through the choice of different nutrient broths, each kit can be tailored to encourage the growth of a specific bacterium. The test kits are being designed to work on a class of bacteria that includes Mycobacterium Tuberculosis, Mycobacterium avium complex ("MAC"), Paratuberculosis, as well as Pseudomonas and Nocardia species. Infectech owns 29 issued patents related to the rapid isolation, growth, identification and antibiotic sensitivity of disease- causing bacteria.

Tuberculosis (TB) kills more people each year than all of the other infectious diseases combined and over 8 million people will die this year because of TB. Tuberculosis is a highly contagious disease transmitted through the air contaminated with droplets released from the lungs. TB strikes people in their most productive years, ages 15 to 44. Of the 2 billion people infected with TB, 200 million worldwide will develop active TB and then be able to infect others. The key to controlling the spread of TB is accurate and fast diagnosis so that treatment can begin. Testing for TB has become mandatory when related to immigration in most countries.

Published data shows that 30% of the individuals that have HIV/AIDS have Tuberculosis (TB). It has also been estimated by world health authorities that more than 70 percent of AIDS patients harbor a MAC infection. It has been shown that MAC also causes opportunistic infections among non-HIV infected pediatric and elderly persons. Infectech's technology allows for the rapid culturing and identification of MAC. It will also provide viable treatment options by testing the particular strain's antibiotic sensitivity. By using saliva or stool samples, this process could identify an infection as much as 10 months before the bacterium could be found in blood samples and well before symptoms begin.

According to estimates from the UNAIDS/WHO AIDS Epidemic Update (December 2004), 37.2 million adults and 2.2 million children were living with HIV at the end of 2004. This is more than 50% higher than the figures projected by WHO in 1991 on the basis of the data then available. During 2004, some 4.9 million people became infected with the human immunodeficiency virus (HIV), which causes AIDS.

The year also saw 3.1 million deaths from AIDS -- a high global total, despite antiretroviral (ARV) therapy, which reduced AIDS-related deaths in the richer countries. Deaths among those already infected will continue to increase for some years even if prevention programs manage to cut the number of new infections to zero. However, with the HIV-positive population still expanding the annual number of AIDS deaths can be expected to increase for many years, unless early diagnosis and more effective provision of ARV medication begins to slow the death rate.

MAC is the primary bacterial infection associated with "wasting syndrome" of HIV/AIDS patients and is a leading cause of death among these patients worldwide. MAC is oftentimes resistant to anti-tuberculosis drugs and there has been no standardized method for determining antibiotic sensitivity. In HIV/AIDS patients, MAC is usually diagnosed after symptoms appear. The diagnostic screen utilizes a blood test. At that time, mortality is very high and time to death is estimated at approximately five months. "With Infectech's Identikits, MAC could be detected significantly sooner than expected for normal culture techniques," stated Paul Hyman, Ph.D. Dr. Hyman is the primary investigator in Infectech's ongoing validation studies.

"Dr. Hyman's validation of Infectech's patented technology and the subsequent FDA registration clearly show that we can identify a costly disease in a fraction of the time," commented Dr. Mitchell Felder, Chief Executive Officer of Infectech. "These results may also have enormous implications in the treatment of TB, AIDS and MAC sufferers, as antibiotic-sensitivity test can now be performed early enough to make a difference in these patients," he added.

About Infectech

Infectech, Inc., http://www.infectech.com/ , is a technology application innovator of biogas products and services designed to assist in worldwide energy independence and reduce pollution from renewable, environmentally- friendly energy sources. Infectech is also engaged in the research and development of diagnostic test kits designed to be used for the rapid identification of infectious human diseases. The Company's patents span the identification and antibiotic sensitivity testing of 34 disease-producing bacteria, including M. tuberculosis (TB), Mycobacterium avium-intracellulare (MAI), pseudomonas and nocardia species. These bacteria are cited as prominent causes of morbidity and mortality in patients with cancer, cystic fibrosis, and AIDS. The Company's 31 patents can be viewed by visiting http://www.infectech.com/intellectual_property.php .

This press release contains statements, which may constitute "forward- looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Those statements include statements regarding the intent, belief or current expectations of Infectech, Inc., and members of its management as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. Important factors currently known to management that could cause actual results to differ materially from those in forward- statements include fluctuation of operating results, the ability to compete successfully and the ability to complete before-mentioned transactions. The company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results.

Infectech, Inc.

CONTACT: Dr. Mitchell S. Felder of Infectech, Inc., +1-724-346-1302

Web site: http://www.infectech.com/http://www.infectech.com/intellectual_property.php

Source: PRNewswire-FirstCall

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