* Advanced Magnetics Inc., of Cambridge, Mass., and MallinckrodtInc., of St. Louis, report that GastroMark, a contrast agent for usewith magnetic resonance imaging of the gastrointestinal tract, hasbeen cleared for marketing in the U.S. GastroMark, the firstsuperparamagnetic oral MRI contrast agent to be marketed in theU.S., will be used to mark the bowel and distinguish the bowel fromadjacent abdominal structures and from areas of suspected pathology.The clearance of GastroMark triggers a milestone payment fromMallinckrodt to Advanced Magnetics. Mallinckrodt will market theproduct in the U.S., Canada and Mexico, with rights to additionalterritories. GastroMark has also been cleared for marketing inwestern Europe, under the brand name, Lumirem.
* American Bio Medica Corp., of Ancramdale, N.Y., has begunshipping the Rapid Drug Screen Kit from its new production facilityat Columbia Advocacy and Resource Centers Inc., a FDA-registeredcontract manufacturer located in Mellenville, N.Y. This eventrepresents the consolidation of all elements of the kit's production atthe COARC facility. All necessary equipment is already in place, thecompany said, and the current manufacturing schedule is set forCOARC to increase production up to 20,000 units per week by Dec.31, 1996.
* Avitech Diagnostics Inc., of Malvern, Pa., and Fox Chase CancerCenter, of Philadelphia, will collaborate on developing clinicalapplications for Fox Chase's novel mutation detection technology.The partners will develop genome diagnostic products and servicesfor BRCA1 and BRCA2, p53 and msh2.
* Beacon Diagnostics Inc., of Foster City, Calif., has begunmarketing its first product, OraScreen HIV Rapid Test, for detectionof antibodies to HIV in saliva, in the Caribbean. OraScreen HIVRapid Test is a multi-step dipstick system that can be performed inthe physician's office or at home in 15 minutes, the company said,without the need for technical training, instruments or a laboratory.
* Biocircuits Corp., of Sunnyvale, Calif., has received clearance fromthe FDA to market its Thyroid Stimulating Hormone assay. The TSHassay will be offered with the company's IOS immunodiagnosticsystem to allow testing in physicians' offices and other points ofpatient care.
* Digene Corp., of Beltsville, Md., reports preliminary results from aclinical study conducted with Kaiser Permanente and Cytyc Corp. todemonstrate the effectiveness of using Digene's Hybrid Capture HPVDNA test for managing women with equivocal Pap smears in amanaged-care environment. Approximately 46,000 women,presenting for routine Pap smears, had cervical specimens collectedfor conventional cytology, liquid-based cytology and HPV DNAdetection by Digene's Hybrid Capture HPV DNA test. Two types ofequivocal Pap smears were studied: ASCUS smears and AGUSsmears. Results showed that 81 percent of the undetermined smearswere classified on follow-up as being normal. The study revealed thatby using Digene's Hybrid Capture HPV DNA test, 88 percent withhigh grade cervical disease were identified.
* Gen-Probe Inc., of San Diego, has added a sensitive, non-invasiveCT test, the Gen-Probe Amplified CT Assay, to its line of top-sellingdiagnostic kits for sexually transmitted diseases. The test, which, thecompany said, can detect as few as one Chlamydia organism presentin a patient's urine sample, is available for use in Europe, Canada,Scandinavia, Australia, South Africa and parts of Asia.
* Genzyme Corp., of Cambridge, Mass., has begun marketing its N-geneous HDL cholesterol test in the U.S., following clearance tomarket the test by the FDA's Administration's Center for Devicesand Radiological Health. The new test measures how much high-density lipoprotein cholesterol is present in a patient's serum and isbeing marketed as a replacement for current HDL cholesterol tests.
* Hoffman-La Roche Inc., of Nutley, N.J., and two leading venturecapital firms, Ampersand Ventures and the Sprout Group, haveformed a new company, AutoCyte Inc., of Burlington, N.C., which isa spin-off of Roche Image Analysis Systems. The company's initialfocus will be the detection and diagnosis of cervical cancer.AutoCyte's products, AutoCyte PREP, a monolayer slide preparationsystem, and AutoCyte SCREEN, a computer-based imaging systemfor screening AutoCyte PREP slides, are currently undergoingclinical trials.
* Oncor Inc., of Gaithersburg, Md., is expanding its overseasmarketing of its HER-2/neu Gene Amplification Test for use in themanagement of breast cancer to those countries where use of the testis approved: Canada, Germany, Denmark, the U.K., Switzerland,Austria, the Netherlands, Ireland and Australia. The test, which isunder pre-market approval review by the FDA in the U.S., has begunclinical trials in France. The Oncor Inform HER-2/neu GeneAmplification Test is designed to aid physicians in predicting thelikelihood of disease recurrence in node-negative breast cancerpatients.
* Pharmacyclics Inc., of Sunnyvale, Calif., said the MedicinesControl Agency in the UK has granted marketing authorization forGADOLITE Oral Suspension for use as a magnetic resonanceimaging contrast agent in the diagnosis of pelvic and abdominaldisorders. The company has also signed an agreement with E-Z-EMLtd., of London, for marketing GADOLITE in the UK.
* Research Corporation Technologies, of Tucson, Ariz., has availablefor licensing a new test that can find kidney disease beforeirreversible structural damage occurs. The assay, which detects aprotein in the urine indicative of kidney disease, may be useful fortracking the progression of kidney disease and monitoring kidneytransplant recipients for early signs of organ rejection.
* Visible Genetics Inc., of Toronto, has acquired exclusive diagnosticrights from Connecticut-based BIOS Laboratories Inc. to atechnology for simplified DNA sequencing. The technology, knownas CAS, combines and replaces the many individual steps of DNAprocessing and sequencing chemistry, as currently practiced, into asimple, single tube, single-step process.
* Vysis Inc., of Downers Grove, Ill., has received 510 (k) clearancefrom the FDA to market the company's CEP 8 SpectrumOrangeDNA Probe Kit, an in vitro diagnostic to identify and enumerateabnormal chromosomes of leukemia patients. CEP 8, the companysaid, is the first IVD test using Fluorescence In Situ Hybridizationtechnology available for clinical use.
* Xenometrix Inc., of Boulder, Co., has signed new distributionagreements to expand the company's presence in certain Europeanand Asian markets. Representing Xenometrix products in Europe willbe Biogenic S.A. in France, Merlin Diagnostics in Germany, andSTAG N.V. in Belgium. Seoulin Scientific of Korea will handleKorean distribution.
(c) 1997 American Health Consultants. All rights reserved.