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Biotech / Medical : BBII -- Ignore unavailable to you. Want to Upgrade?


To: Barry Shore who wrote (9)3/26/1999 12:37:00 PM
From: DRRISK  Respond to of 28
 
Thread,

Boston Biomedica Presents Pathogen Inactivation Data Using Pressure Cycling Technology (PCT) at Blood Safety Conference
PR Newswire - February 26, 1999 14:58

WEST BRIDGEWATER, Mass., Feb. 26 /PRNewswire/ -- Boston Biomedica, Inc. (Nasdaq: BBII) announced today that early results on its proprietary Pressure Cycling Technology (PCT) show the ability of the PCT process to inactivate pathogens in plasma while preserving the therapeutic properties of important plasma proteins. In data presented at Cambridge Healthtech Institute's Fifth Annual Blood Safety and Screening Conference in McLean, VA, Mark Manak, Ph.D., Sr. Vice President for Research and Development at BBI, illustrated PCT's effectiveness in killing certain bacteria, yeast and viruses, while the activity of coagulation factors, antibodies, enzymes and growth factors was retained.

Inactivation of known and potential pathogens in human plasma is important to ensuring the safety of the plasma supply for transfusion and for plasma- derived products such as Factor VIII and immune globulins. BBI researchers, in collaboration with BMA Laboratories, Inc., Woburn, MA, St. Joseph's Health Center, Toronto, Canada, and the Clinical Chemistry Laboratories at the National Institutes of Health, Bethesda, MD, have demonstrated the effectiveness of PCT in killing bacteria such as E. coli, Pseudomonas aeruginosa and Staph. Aureus, yeast such as C. albicans, and viruses such as HIV and herpes simplex, while the activity of Factor VIII and immune globulins is largely retained.

"Although PCT has not yet been demonstrated to effectively inactivate hardy viruses such as parvovirus, and some of the more fragile proteins were denatured in these early experiments, we hope to be able to optimize conditions to balance effective killing of pathogens with retention of therapeutically important plasma factors," Dr. Manak commented. "The first generation of automated prototype PCT instruments has been manufactured at BBI's Source Scientific subsidiary and will be shipped to our researchers and collaborators within the next few weeks. The advantages of these automated instruments over the manual prototypes now in use should allow us to move ahead more quickly."

"These preliminary studies have greatly encouraged us that we may be able to address some important concerns for the safety of plasma and plasma-derived products, and potentially improve the safety of the work environment for people who handle blood samples by providing an instrument that can inactivate pathogens in plasma as samples are prepared for shipment or analysis," added Richard T. Schumacher, President and CEO of BBI. "Our process has the potential to allow rapid, automated pathogen inactivation in the collection container, without potentially toxic additives, and without a requirement for pooling samples or units from different donors."

Boston Biomedica Inc. recently acquired pressure cycling technology (PCT), a proprietary, novel, enabling technology platform with applications to many products and industries from BioSeq, Inc. The technology uses safe, simple- to-use equipment capable of rapidly cycling pressure between relatively low and high levels. This reversibly and repeatedly modulates the solid and liquid phases of solutions and the binding interactions of biomolecules. Pressure has many advantages as a control parameter including being instantaneously and uniformly transmitted through any volume of liquid; its actions are often enhanced by the use of low temperatures. In many cases, PCT functions to modify biomolecules without the addition of any toxic or denaturing reagents. Boston Biomedica has chosen to initially employ PCT in the major areas of (1) pathogen inactivation and (2) cell and tissue disruption and nucleic acid extraction.

Boston Biomedica Inc. is a worldwide manufacturer and provider of proprietary quality control products for use with IVD test kits for the detection, analysis and monitoring of infectious diseases, including AIDS, Hepatitis, Lyme Disease and ToRCH. The Company's products are used by clinical and research laboratories, blood banks, and IVD manufacturers to help ensure the accuracy of infectious disease test results through the routine monitoring of test performance. The Company also manufactures diagnostic test kit components and laboratory instrumentation, provides specialty laboratory testing and contract research services, and has significant R&D investment in PCT and drug discovery.

Statements contained in this news release that state the Company's or management's intentions, hopes, beliefs, expectations or predictions of the future are "forward-looking" statements. It is important to note that the Company's actual results could differ materially from those projected in such forward-looking statements. Factors that could cause actual results to differ from those projected include the possibility that due to unforeseen technical, financial and other difficulties BBI BioSeq may not be able to develop its PCT technology into commercially successful products, or such development may take longer than currently expected. There can be no assurances that BBI BioSeq will be successfully integrated into Boston Biomedica's overall operations. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements is contained from time to time in the Company's SEC filings, including but not limited to the Company's report on Form 10-Q for the period ended June 30, 1998. Copies of this document may be obtained by contacting the Company or the SEC.

Visit us at our website bbii.com

Please email us at IR@bbii.com if you prefer to receive future announcements electronically

SOURCE Boston Biomedica, Inc.

/CONTACT: Richard T. Schumacher, President & CEO or William R.
Prather, MD, Sr. VP Business Development both of Boston Biomedica Inc.,
508-580-1900/

DrRisk more to come



To: Barry Shore who wrote (9)3/26/1999 12:39:00 PM
From: DRRISK  Respond to of 28
 
Thread,

Boston Biomedica Announces 510(K) Clearance For Lyme IgM Western Blot Kit
PR Newswire - March 25, 1999 16:55

WEST BRIDGEWATER, Mass., March 25 /PRNewswire/ -- Boston Biomedica Inc. (Nasdaq: BBII) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Borrelia burgdorferi IgM (Lyme IgM) Western Blot test kit. The test is used following a screening test as part of a two-step process for determination of recent exposure to B. burgdorferi, the causative agent of Lyme disease.

"BBI initially developed the Lyme IgM and its companion IgG Western blot tests at BBI Biotech Research Laboratories (BBI Biotech) for use at BBI Clinical Laboratories (BBICL). Our positive experience with these tests in our own laboratories led us to the decision to seek FDA clearance for commercial distribution," said Richard C. Tilton, Ph.D., Senior Vice President and Scientific Director, BBICL. "BBI Biotech has a long and distinguished history in development of diagnostic tests for infectious disease markers, and more recently for nucleic acids of clinical interest. Therefore, it is no surprise that we have found these Lyme disease tests superior to others we have evaluated."

"The continued success of both tests at BBICL, and the clearance of the Lyme IgM test for commercial distribution, demonstrate again the synergy that we have built among our business units," stated Richard T. Schumacher, President and CEO of BBI. "A test that has been developed and manufactured through our research and development group (BBI Biotech) for use at our clinical laboratories (BBICL) will now become available for OEM distribution from our diagnostics group (BBI Diagnostics). We are very pleased at having achieved a relatively expeditious clearance for the IgM Western Blot test, and are now preparing to submit to FDA the data for the companion Lyme IgG test kit."

BBI Biotech (Gaithersburg, Maryland) offers a variety of research services in molecular biology, cell biology and immunology to government agencies, diagnostic kit manufacturers and biomedical researchers. BBICL (New Britain, Connecticut) is a fully accredited specialty reference laboratory dedicated to the laboratory diagnosis of infectious diseases, and in addition is FDA registered for blood bank supplemental testing for HIV, HTLV and viral hepatitis.

Boston Biomedica Inc. is a worldwide manufacturer and provider of proprietary quality control products for use with IVD test kits for the detection, analysis and monitoring of infectious diseases, including AIDS, Hepatitis, Lyme Disease and ToRCH. The Company's products are used by clinical and research laboratories, blood banks, and IVD manufacturers to help ensure the accuracy of infectious disease test results through the routine monitoring of test performance. The Company also manufactures diagnostic test kit components and laboratory instrumentation, provides specialty laboratory testing and contract research services, and has significant R&D investment in pressure cycling technology (PCT) and anti-HIV drug discovery.

Statements contained in this news release that state the Company's or management's intentions, hopes, beliefs, expectations or predictions of the future are "forward-looking" statements. It is important to note that the Company's actual results could differ materially from those projected in such forward-looking statements. Factors that could cause actual results to differ from those projected include the possibility that due to unforeseen technical, financial, marketing, and other difficulties, the Lyme disease test kits described may not ultimately be commercialized, or if commercialized, may not be financially successful for the Company, and the Lyme IgG test kit may not receive FDA 510(k) clearance. Additional information concerning factors that could cause actual results to differ materially from those in the forward- looking statements is contained from time to time in the Company's SEC filings, including but not limited to the Company's report on Form 10-Q for the period ended June 30, 1998. Copies of this document may be obtained by contacting the Company or the SEC.

Visit us at our website bbii.com Please email us at IR@bbii.com if you prefer to receive future announcements electronically

SOURCE Boston Biomedica, Inc.

/CONTACT: Richard T. Schumacher, President & CEO, or Kevin W. Quinlan,
Chief Financial Officer, or William R. Prather, MD, Sr. VP Business
Development of Boston Biomedica Inc., 508-580-1900/

DrRisk more to come



To: Barry Shore who wrote (9)3/26/1999 12:57:00 PM
From: DRRISK  Read Replies (1) | Respond to of 28
 
Thread,

Imho this is a great company that is a buy due to its potential as well as its core business. They are the gold standard for controls in the infectious disease diagnostic market. Their research effort could be huge on the upside. They have a technology in pressure cycling that is applicable in nucleic acid extraction and plasma inactivation which is patented and proprietary. The drug discovery program is early but could yield considerable value.

They are finally breaking out of their no volume blues and this is a company that has no where to go but up IMHO. Debt is only 3 million no convertible vehicles in place and they have earnings which is always a plus. Small float 4.8 million with large insider ownership. Grew revenues in 97-98 at 17% with projection for 17%+ in 1999.

Recent National Securities put buy on stk.

FWIW and IMHO.

DrRisk I like this company