The following is a review of diagnostic product developments worldwide
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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.
Product developments in May 2001
AcroMetrix Corporation has launched its HIV Resistance Proficiency Program for molecular diagnostic laboratories using advanced HIV genotyping tests. The program provides participating laboratories with five encoded challenge specimens for mutation analysis.
American Bio Medica Corp.'s Drug Detector is now available in Eckerd drug stores. The kit detects IDENTIFIES minute traces of illicit substances on common surfaces.
Amplistar, Inc., has signed an exclusive worldwide license agreement with Virginia Mason Research Center, to commercialize blood tests for the early detection of ovarian cancer.
Applied Imaging Corp. has signed an exclusive supply agreement with StemCell Technologies, Inc. for use of the RosetteSep reagent technology in the isolation of circulating tumor cells in the blood of cancer patients. The RosetteSep technique uses StemCell's patented tetrameric antibody complex (TAC) technology to enrich circulating tumor cells directly from samples of cancer patients' whole blood. Preclinical trials of the combined RosetteSep/MDS method have begun in two major European cancer centers among separate groups of breast cancer and colorectal cancer patients.
Bayer Corporation and Matsushita Electric Industrial Co., Ltd. have entered into a long-term, strategic business relationship to jointly develop, manufacture and market diagnostic products. Bayer Corporation will acquire rights for the sale and marketing of newly developed diagnostics products and services and Matsushita Electric will be primarily responsible for the development and manufacturing of new products and services.
BioCurex Inc. has introduced HISTO-RECAF, a immunohistochemical kit that allows the differentiation of cancer cells from normal cells, as well as differentiating malignant tumors from benign tumors.
Bio-Rad Laboratories has launched its new DNA-based products, the mDx line of Analyte Specific Reagents (ASR) for Hereditary Hemochromatosis. American Medical Laboratories, Inc. (AML) has begun using the kit.
Cepheid and the University of Pittsburgh School of Medicine are developing a rapid genetic test to help doctors evaluate lymph node biopsies for the spread of cancer at the time of surgery. The company suggests that the new test may detect the presence of rare tumor cells often missed by conventional microscopic evaluation.
Chiron Corporation and Roche Diagnostics have reached an agreement giving Roche the ability to manufacture and sell probe-based HIV-1 and HCV blood screening tests worldwide, in both single donor and pooled formats, for the life of the patents. This license contains new royalty rates that are based on the number of donations tested and not on test kits sold. Chiron and Roche have agreed that in certain regions of the world, including Africa and most of Asia, the HIV-1 license will be free of royalties. In addition, the parties have agreed that the HCV royalties will be discounted in these regions.
Digene Corporation has terminated its marketing and distribution agreement with Abbott Laboratories related to Digene's human papillomavirus (HPV) DNA tests and accessories. Digene also announced that it has converted the distribution rights under the Abbott / Digene Agreement for the Digene Hepatitis B DNA tests to non-exclusive for the remainder of the term of the agreement.
Gen-Probe Incorporated has received FDA clearance to market its APTIMA Combo 2 Assay, a target-amplified nucleic acid probe test for qualitative detection of rRNA from Chlamydia trachomatis and Neisseria gonorrhoeae in endocervical and male urethral swab specimens and urines from symptomatic and asymptomatic males and females. Both bacteria are detected and identified using a single specimen and test.
Genzyme General has purchased Wyntek Diagnostics Inc. for $65 million in cash. Wyntek generated $17.5 million from sales of rapid test products in 2000, and it expects sales this year to reach $25 million. Both Genzyme and Wyntek currently offer rapid test products for the diagnosis of pregnancy, Strep A, and infectious mononucleosis. In addition, both are developing distinct quantitative rapid tests for use in the cardiovascular diagnostic market.
Guardian Angel Holdings, Inc.'s Guardian Angel Personal Alcohol Test is now available at participating 7-Eleven stores in the US. The suggested retail price is $1.39.
Hemagen Diagnostics, Inc. is developing a new diagnostic test kit to identify individuals that have an antibody that appears to neutralize the HIV virus and prevents the HIV from progressing into full-blown AIDS. The test is based on a discovery by Professor Jean-Claude Chermann that a specific antibody, called R7V, appears in almost all HIV-positive individuals who have not developed into the AIDS disease, and are therefore considered to be long-term survivors or non-progressors.
Johnson & Johnson has acquired Inverness Medical Technology in a stock-for-stock exchange. Inverness will split off its businesses in women's health, nutritional supplements and clinical diagnostics to form a new publicly traded company owned by Inverness shareholders. Johnson & Johnson will buy the Inverness diabetes care products businesses.
Laboratory Corporation of America has acquired Path Lab Holdings, Inc. Path Lab had revenues in 2000 of approximately $51.6 million. Terms of the transaction were not disclosed. LabCorp announced that "The acquisition of Path Lab is a continuation of our plan to make selective, strategic acquisitions that not only expand our geographic coverage, but also leverage our expertise in esoteric testing. Our plan is to use Path Lab's facilities and seasoned management team to form the cornerstone of LabCorp's expansion into New England."
Quantech Ltd. and Diametrics Medical, Inc. have signed an OEM agreement under which Quantech will use Diametrics' technology to provide electrolyte testing capability in its FasTraQ instrument system. The FasTraQ system is currently in clinical trials in preparation for submission to the FDA.
Quidel Corporation has received FDA clearance to market its QuickVue Dipstick Strep A test. This new test is Quidel's first dipstick-style Strep A test and adds to the company's existing portfolio of Strep A tests, which includes QuickVue In-Line Strep A test, QuickVue Flex Strep A test, and the CARDS O.S. Strep A test.
Sigma has begun distribution of Ambion, Inc.'s patented RNA stabilization product RNAlater for the research market, on a non-exclusive basis. RNAlater stabilizes RNA in tissues and cells for subsequent RNA isolation and for ambient temperature shipping and storage of samples.
Product developments - April 2001
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Last modified: June 02, 2001