AMDL Inc., of Tustin, Calif., filed a 510(k) premarket notificationwith the FDA for PyloriProbe, a direct enzyme immunoassay fordetection of Helicobacter pylori. The product detects H. pyloriantibodies. It is the company's first application.
Biopool International Inc., of Ventura, Calif., received 510(k)approval to market the TintElize PAI-1 Assay Kit, which measuresthe level of plasminogen activator inhibitor-1 in blood. PAI-1 is anatural protein that inhibits tPA.
Boston Life Sciences Inc., of Boston, said a Phase I/II study of theParkinson's disease diagnostic agent, Altropane, showed it to be asafe, accurate and convenient agent to detect changes in thedopamine transporter system in the brain of nine Parkinson's diseasepatients. Altropane and brain scanning demonstrated a loss of morethan 70 percent of dopamine transporters in patients with mildclinical disease.
* ChemTrak Inc., of Sunnyvale, Calif., received marketing clearancefor its rapid test for Helicobacter pylori. The test is a disposable,whole-blood vehicle that detects H. pylori antibodies. Astra MerckInc., of Wayne, N.J., will market the product in the U.S. under thename Hp Chek.
* Cygnus Inc., of Redwood City, Calif., signed an agreement withYamanouchi Pharmaceutical Co. Ltd., of Tokyo, for marketing rightsin Japan and Korea for GlucoWatch, a glucose monitoring device.Cygnus could receive up to $10 million in up-front and milestonepayments, plus royalties.
* ID Biomedical Corp., of Vancouver, B.C., said the first trial of itstest for methicillin-resistant Staphylococcus aureus showed it wasable to discriminate with 100 percent accuracy the presence orabsence of the mecA gene, which is responsible for drug resistance.The company plans to convert the test to a non-radioactive format.
* Immunomedics Inc., of Morris Plains, N.J., began a pivotal PhaseIII trial of LymphoScan, a nuclear imaging product for detectinglymphoma. The 250-patient study will assess LymphoScan's abilityto detect the presence, location and extent of non-Hodgkin'slymphoma.
* Meridian Diagnostics Inc., of Cincinnati, purchased the entericproduct line of Cambridge Biotech Corp., of Worcester, Mass., for$5.5 million in cash, an advance on royalties and otherconsiderations. The line includes tests for adenovirus, rotavirus, C.difficile, and Lyme disease.
* Oncor Inc., of Gaithersburg, Md., obtained an exclusive worldwidelicense to the p43 blood test for detecting early stage breast cancer.Oncor intends to conduct further test before submitting a premarketapproval application. Oncor intends initially to market the test as acompanion to conventional mammograms in high-risk women.
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