Meridian Bioscience Comments on Influenza Samples
Apr 15, 2005, 16:17, Reviewed by: Dr.
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On 8 April, after a request by the US government, CAP asked all laboratories which participated in the proficiency testing to immediately destroy samples containing the H2N2 virus. On 12 April, a second correspondence from CAP to these laboratories further requested that destruction of the H2N2 virus be confirmed and that any case of respiratory disease among laboratory workers be investigated and notified to national authorities.
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By Meridian Bioscience,
Commenting on the recent reports in the general press regarding the recommendation by the World Health Organization (WHO) that testing laboratories destroy proficiency samples containing influenza A virus, the Company noted it produces such samples for the College of American Pathologists (CAP). Such samples are used by professional laboratories accustomed to handling viral agents. For fiscal year 2004, the Company's CAP sales and operating income were approximately $3.0 million (4% of total sales) and $750,000 (5% of total operating income), respectively. The Company has a long history of supplying samples to the CAP and believes it has been and is in compliance with all applicable regulations. Further to this topic, the Office of Communication for the Centers for Disease Control stated, in part, in their media relations statement dated April 12, 2005:
"On 8 April, after a request by the US government, CAP asked all laboratories which participated in the proficiency testing to immediately destroy samples containing the H2N2 virus. On 12 April, a second correspondence from CAP to these laboratories further requested that destruction of the H2N2 virus be confirmed and that any case of respiratory disease among laboratory workers be investigated and notified to national authorities. WHO has received the list of addresses of the involved laboratories and has provided detailed contact information to the relevant Ministries of Health and requested their collaboration.
As of today, there have been no reports of H2N2 infections in laboratory workers associated with the distribution of the H2N2 samples from CAP. The proper use of biological safety cabinets, along with the use of recommended personal protective equipment, greatly reduces the risk of laboratory-acquired influenza infections. While a few H2N2 laboratory acquired infections have been documented in the past, the likelihood of laboratory-acquired influenza infection is considered low when proper biosafety precautions are followed. The risk for the general population is also considered low.
As a precautionary measure, WHO is recommending that all samples of the proficiency testing panel from CAP and any other proficiency testing providers containing H2N2 and any derivates be destroyed immediately. WHO further recommends that biosafety procedures be reviewed for use on influenza viruses that have not circulated recently in humans and against which the majority of the population would have no protective immunity." 
- Meridian Bioscience
www.meridianbioscience.com
Meridian Bioscience, Inc., (NASDAQ:VIVO) today announced that, based on preliminary results, it expects to report net sales of approximately $23.5 million and diluted earnings per share of between $0.19 and $0.20 for the quarter ended March 31, 2005. For the same period of the previous fiscal year, sales and diluted earnings per share were $20.94 million and $0.15, respectively. The Company will report its final results for the fiscal second quarter on April 21, 2005. Meridian Bioscience also reaffirmed its guidance for the fiscal year ending September 30, 2005, of sales between $84 million and $88 million and diluted earnings per share between $0.66 and $0.70.
FORWARD LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, this report contains forward-looking statements which may be identified by words such as "estimates", "anticipates", "projects", "plans", "seeks", "may", "will", "expects", "intends", "believes", "should" and similar expressions or the negative versions thereof and which also may be identified by their context. Such statements are based upon current expectations of the Company and speak only as of the date made. The Company assumes no obligation to publicly update any forward-looking statements. These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ, including, without limitation, the following: Meridian's continued growth depends, in part, on its ability to introduce into the marketplace enhancements of existing products or new products that incorporate technological advances, meet customer requirements and respond to products developed by Meridian's competition. While Meridian has introduced a number of internally developed products, there can be no assurance that it will be successful in the future in introducing such products on a timely basis. Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may cause adverse changes to pricing and distribution. Costs and difficulties in complying with laws and regulations administered by the United States Food and Drug Administration can result in unanticipated expenses and delays and interruptions to the sale of new and existing products. Changes in the relative strength or weakness of the U.S. dollar can change expected results. One of Meridian's main growth strategies is the acquisition of companies and product lines. There can be no assurance that additional acquisitions will be consummated or that, if consummated, will be successful and the acquired businesses successfully integrated into Meridian's operations.
Meridian is a fully integrated life science company that manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. Utilizing a variety of methods, these products provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral, and respiratory infections. Meridian diagnostic products are used outside of the human body and require little or no special equipment. The Company's products are designed to enhance patient well-being while reducing the total outcome costs of healthcare. Meridian has strong market positions in the areas of gastrointestinal and upper respiratory infections, serology, parasitology and fungal disease diagnosis. In addition, Meridian is a supplier of rare reagents and specialty biologicals along with proteins and other biologicals used by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices and diagnostics manufacturers in more than 60 countries around the world. The Company's shares are traded through Nasdaq's National Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.
CONTACT: Meridian Bioscience, Inc.
John A. Kraeutler, 513-271-3700
SOURCE: Meridian Bioscience, Inc.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding Meridian Bioscience, Inc's business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently ended fiscal year.
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