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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI -- Ignore unavailable to you. Want to Upgrade?

To: USRX888 who wrote (3398)	6/23/1998 6:37:00 PM
From: Gurupup	Read Replies (3) \| Respond to of 5736

Tuesday June 23, 6:12 pm Eastern Time Company Press Release SOURCE: Chromatics Color Sciences International, Inc. Chromatics Color Sciences Reaffirms American Medical Association's Confirmation of CPT Code NEW YORK, June 23 /PRNewswire/ -- CHROMATICS COLOR SCIENCES INTERNATIONAL, INC. (Nasdaq: CCSI - news) today reaffirmed that on February 17, 1998 the Company's regulatory consultant on third party reimbursement, Health Systems Concepts, received a letter from the American Medical Association (in response to its inquiries regarding the applicable CPT Code for the neonate bilirubin test performed by the Company's device) confirming that the applicable CPT Code would be 82250 Bilirubin, Total or Direct. The Company is responding to the allegations made by Asensio & Co. regarding the Colormate(TM) TLc- BiliTest(TM). Further, a report to the Company by Health Systems Concepts states that ''the AMA CPT Information Services confirmed that CPT Code 82250 Total Bilirubin is the correct code for reporting a bilirubin test. Use of this code is not based on the device type or place of service (Lab vs. point of care). Code use is based on whether the determination of Total Bilirubin is quantitative; if it is a quantitative assay the correct Code is 82250 Bilirubin, Total or Direct.'' The CPT Code is the Code necessary to permit third party insurance reimbursement of the bilirubin test provided by the Company's device. The Company's clearance letter from the Food and Drug Administration allows the Intended Use of the Colormate device ''to provide a numerical index of predicted serum bilirubin count in mg/dl that has been shown to correlate with Total serum Bilirubin concentration within a clinically useful range,'' which is a quantitative assay and further ''falls within the classification of 21 CFR 862.1113 Bilirubin (total and unbound) in the neonate test system.'' Darby Macfarlane, Chief Executive Officer of Chromatics, stated ''the Company is unaware of any change regarding this confirmation by the AMA and is currently reviewing its legal remedies regarding these and other allegations by Asensio & Co.'' Chromatics Color Sciences is in the business of color science and has developed technologies and intellectual properties which it believes have medical applications involving the detection and monitoring of certain chromogenic diseases or disorders such as bilirubin infant jaundice. The Company defines chromogenic diseases or disorders as those diagnosed or monitored by the coloration of the human skin, tissue or fluid being affected. In this regard, the Company has received Food and Drug Administration (FDA) clearance for commercial marketing of its medical device for detection and monitoring of bilirubin infant jaundice. Other medical applications will require additional clinical trials and FDA clearance. The Company's technologies and intellectual properties also have other applications, including the scientific color measurement and classification of human skin, certain color-sensitive consumer products, and in determining the color compatibility of such skin and product color classification for use in a variety of industries including the cosmetic, beauty-aid and fashion industries. Certain of the matters discussed in this announcement contain forward- looking statements that involve material risks to and uncertainties in the Company's business which may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include, among other things, the availability of any needed financing, the Company's ability to implement its long range business plan for various applications for its technologies, the impact of competition, the obtaining of further regulatory clearances applicable to proposed new applications of the Company's technology, management of growth and other risks and uncertainties that may be detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including those set forth in its annual report on Form 10-K for the year ended December 31, 1997. SOURCE: Chromatics Color Sciences International, Inc. ------------------------------------------------------------------------ More Quotes and News:Chromatics Color Sciences International Inc (Nasdaq:CCSI - news)Related News Categories: medical/pharmaceutical