KITS...this stock looks good even before todays news. I biotech that actually makes money?!? Insiders buying nobody selling
Meridian Type-Specific Herpes Tests Receive FDA
Clearance to Market
Business Wire - July 12, 1999 13:48
CINCINNATI--(BW HealthWire)--July 12, 1999--Meridian Diagnostics, Inc., Cincinnati,
Ohio, (Nasdaq:KITS) today announced that it has received clearance from the United States
Food and Drug Administration (FDA) to market two diagnostic tests for the herpes simplex
virus.
These tests, Premier(TM) Type-Specific HSV-1 IgG ELISA Test and Premier(TM)
Type-Specific HSV-2 IgG ELISA Test, are the first medical tests cleared by the FDA that
have been proven to be able to distinguish Herpes Simplex Virus (HSV) Type 1 (oral herpes)
from Type 2 (genital herpes) herpes infections via serological blood test methods. Most
commercial serological tests have been of limited use in the diagnosis of herpes largely because
of their inability to distinguish between HSV types 1 and 2. With the FDA clearance of these
two blood tests, the discrimination between HSV-1 and HSV-2 infections now can be routinely
made in any clinical laboratory.
HSV infection is the third most prevalent sexually transmitted disease in the United States. From
200,000 to 500,000 people contract the HSV infection annually with as many as 30 million
Americans infected with HSV-2. The benefit of the Premier(TM) Type-Specific HSV-2 IgG
ELISA Test is its capability to aid in the accurate diagnosis of genital herpes. Experts anticipate
that more precise diagnosis will help decrease the spread of this infection, which has grown
more than 30% over the last two decades.
Approximately two-thirds of people with HSV-2 infections go undiagnosed either because they
do not have noticeable symptoms or because their symptoms do not fit the typical pattern of
HSV-2. These undiagnosed infections represent one of the main reasons for transmission of
HSV-2 from genital infections to sexual partners, which ultimately can lead to herpes infections
in the newborn. Individuals are not being diagnosed because patients are not exhibiting
symptoms, and the tests that are currently available do not provide accurate results.
John Kraeutler, President and Chief Operating Officer, stated, "The greatest value of these new
tests lies in their ability to identify individuals who are unaware that they have an HSV-2
infection and are capable of unknowingly transmitting the virus to others." He added, "The
availability of these new herpes tests also makes it easier for pregnant women and their partners
to be tested which can help reduce the risk of neonatal herpes." With the new treatment options
now available to the clinician, there is an increasing need for type-specific serological
identification of HSV-2 infections. No cure exists for HSV but antiviral medications such as
Zovirax(R) and Valtrex(R) by Glaxo Wellcome (Nasdaq:GLX) are available for HSV
infections. This therapy helps lengthen the time between outbreaks and lessens the severity of
subsequent outbreaks.
Meridian Diagnostics, Inc. is a fully integrated medical diagnostic company that develops,
manufactures and markets a broad range of innovative diagnostic test kits, purified reagents and
related products. Utilizing a variety of technologies, these products provide accuracy, simplicity
and speed and enable early diagnosis and treatment of common medical conditions such as
gastrointestinal, viral, urinary tract and respiratory infections. All of the Company's products are
designed to enhance patient well-being while reducing total outcome costs of healthcare.
Meridian has strong market positions in the areas of fungal disease diagnosis, parasitology,
gastrointestinal infections, and upper respiratory conditions. All Meridian products are used
outside of the human body and require little or no special equipment. The Company markets its
products to hospitals, reference laboratories, and physician offices in more than sixty countries
around the world. The Company's shares are traded through Nasdaq National Market, symbol
KITS.
CONTACT: Meridian Diagnostics, Inc., Cincinnati
Gerard Blain, 513/272-5232 |
