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The following is a review of diagnostic product developments worldwide

The information is updated the first week of every month - so ... make this a regular stop in your information gathering activities.

The following information has been compiled from publicly available sources, StratCom does not assume any responsibility for the accuracy or the authenticity of the information and StratCom cannot be held liable for errors.

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Product developments in June 2000

Alpha Therapeutic Corp. has obtained a US patent for a method of rapidly testing large numbers of plasma donations for viruses. The method uses PCR to test pools of up to 512 blood units. If a pool tests positive, an algorithm is applied to determine the order of further testing, so that the reactive sample(s) in the pool can be identified with a minimum of 26 tests, rather than the 512 tests needed to screen each sample individually. Alpha has granted an exclusive license to National Genetics Institute to use the method.

American Bio Medica will introduce its OTC wipe-and-spray Drug Detector kit that tests for the presence or absence of crack/cocaine or marijuana residue on surfaces, such as desk tops, book bags and steering wheels. The patented Drug Detector kit includes an aerosol spray for either crack/cocaine or marijuana, 10 collection papers and instructions. Users wipe any surface with a collection paper and spray the paper with the aerosol can. If positive, the paper will turn blue for cocaine and reddish brown for marijuana within seconds. Later in 2000 the company will offer the Drug Detector for methamphetamine and heroine, in addition to the cocaine and marijuana tests, in larger, industrial-size versions of 50-100 tests.

Ampersand Medical Corporation and Invirion are developing a POC HPV screen probe technology based on the use of a fluorescence oligonucleotide detection platform, utilizing genomics data from the Human Genome Project. The method combines Ampersand's InPath System, a bio-molecular based technology for cervical cancer screening, and Invirion's HPV screening technology

Beckman Coulter, Inc. and Micronics, Inc. are developing a CLIA-waived, lab-on-a-chip-based hematology system for the point-of-care market.

BioGenex has introduced the i6000 automated staining system, an "All-in-One/All-at-Once" instrument, a walk-away immunohistochemistry system with a capacity of 60 slides and 60 reagents and a throughput of up to 250 slides per eight-hour period. The instrument simultaneously can process immunohistochemistry, in situ hybridization, special stains, and H & E slides -- in the same run.

ACLARA BioSciences, Inc. and Cepheid have been awarded a $3.0 million DARPA grant to develop an integrated microfluidic system designed to perform automated measurements to simultaneously detect biological agents or genetically engineered variants. The system will combine Cepheid's proprietary microfluidic based sample preparation technology with ACLARA's assay chemistries and microfluidic processing technology, integrated to run on ACLARA's plastic LabCard chips.

Transfusion Technologies Corp. announced is developing the Chairside Separator System, that automates the collection and separation of a single unit of whole blood at the point of collection.

LabOne, Inc. and Epitope, Inc. are developing a laboratory-based oral fluid screening test for Hepatitis C antibodies. The new test uses Epitope's OraSure oral fluid collection device. The agreement covers both U.S. and international markets. LabOne will financially contribute toward outside development and clinical study costs. Epitope will be responsible for marketing the Hepatitis C testing kit, which includes an OraSure device, instructions for use, a return air express mailer and a patient identification form for use in returning the results. It is anticipated that negative test results will be provided to the testing site within 24 hours of receipt of the sample, and that positive results will be available within 72 hours.

ID Biomedical Corporation and PE Biosystems have entered into a worldwide, non-exclusive license granting PE Biosystems access to ID Biomedical's Cycling Probe Technology. The license will allow PE Biosystems to use the technology for genomics testing, high throughput screening and the development of assays to detect nucleic acid sequences.

InMedica has licensed its patented, noninvasive hematocrit technology, CritTrend, to Wantagh, Inc. of Bristol, PA. This exclusive license is limited to the inclusion of the CritTrend technology into Wantagh's, FDA approved, noninvasive hemodynamic/cardiac performance monitor, the IQ System. InMedica, through its wholly owned subsidiary MicroCor, Inc., is developing a technology that measures hematocrit noninvasively through the skin using electrical impedance.

La Jolla Diagnostics, Inc. has announced a name change to NatureWell, Inc. The name change reflects the Company's increasing focus on its expanding line of personal healthcare products and it's Internet site, www.NatureWell.com. The company's DiagnosTech subsidiary has recently concluded an agreement with Meridian Diagnostics for the worldwide marketing by Meridian of the rapid test for active TB.

LabCorp has acquired National Genetics Institute, Inc. The acquisition of NGI gives LabCorp access to NGI's ultra-sensitive tools to assess HCV disease progress and a comprehensive molecular diagnostic and specialty testing network. LabCorp has also acquired Pathology Medical Laboratories (PML). PML provides with additional testing and patient service sites.

Lignex, Inc. has acquired International Biotech Corporation, Edmonton, Alberta. International Biotech Corporation and thus access to a home test kit for HIV-1&2. IBC is responsible for obtaining all necessary approvals to market the home test kits.

Magellan Technology Inc. and its subsidiary BioMeridian International Inc. have introduced the BTA S-2000, a software product that offers a computerized analysis of a patient's body chemistry. After collecting samples of a patient's blood, urine and saliva, the health care practitioner performs a 10-minute BTA test resulting in a complex evaluation of the patient's cellular health.

Matritech, Inc. has acquired ADL, located in Freiburg, Germany, a European distributor of diagnostic testing products including the company's NMP22 test kit for bladder cancer.

Molecular Devices Corp. will acquire LJL BioSystems Inc. in a $262.8 million stock swap. Both companies develop bioanalytical measurement systems for drug discovery research. Together, they have an installed base of more than 15,000 systems and products at the largest pharmaceutical and biotechnology companies.

Qualigen, Inc., formerly Qualisys Diagnostics, Inc., has announced the European launch of its FastPack System, a fully automated POC system designed specifically to perform quantitative immunoassay tests in physician offices and small laboratories. The initial test available on the FastPack System is PSA. Free PSA and testosterone, are scheduled for introduction later in 2000.

Roche Diagnostics has acquired the Medical Division of AVL, a supplier of blood gas and electrolyte analyzers.

TCPI has acquired Roche Diagnostics' worldwide OTC pregnancy and ovulation testing business including trademarks and distribution rights related to these products. The worldwide OTC home pregnancy and ovulation business assets being acquired by TCPI generated more than $7 million in sales in 1999. These assets are being acquired for $7 million in cash payable on a scheduled basis.

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* Product developments - May 2000
* Product developments - April 2000
* Product developments - March 2000
* Product developments - Febuary 2000
* Product developments - January 2000
* Product developments - December 1999
* Product developments - November 1999
* Product developments - October 1999
* Product developments - September 1999
* Product developments - August 1999
* Product developments - July 1999
* Product developments - June 1999
* Product developments - May 1999
* Product developments - April 1999
* Product developments - March 1999
* Product developments - Febuary 1999
* Product developments - January 1999
* Product developments - December 1998
* Product developments - November 1998
* Product developments - October 1998
* Product developments - September 1998
* Product developments - August 1998
* Product developments - July 1998
* Product developments - June 1998
* Product developments - May 1998
* Product developments - Avril 1998
* Product developments - March 1998
* Product developments - February 1998
* Product developments - January 1998
* Product developments - July 1997
* Product developments - June 1997
* Product developments - May 1997
* Product developments - April 1997
* Product developments - March 1997
* Product developments - February 1997
* Product developments - January 1997
* Product developments - December 1996
* Product developments - November 1996
* Product developments - October 1996
* Product developments - September 1996
* Product developments - August 1996
* Product developments - July 1996
* Product developments - June 1996

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