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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI

CCSI 24.53

-1.8%

Nov 7 9:30 AM EST

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To: Steve who wrote (3422)	6/23/1998 9:47:00 PM
From: JanyBlueEyes	Read Replies (2) of 5736

I tend to believe what the expert says: 1. "The potential market for all bilirubinometers is extremely limited...." Dr. Maisels' response is: "I cannot claim expertise in how "markets" are calculated, but the potential for the use of transcutaneous bilirubinometry involves the majority of babies born in the world. Recent data show that as many as 90% of U.S. infants will have clinical jaundice in the first week. While it is true that only babies that appear jaundiced are currently tested for bilirubin, because most infants are now discharged from hospitals before they are 36 hours old, the overwhelming majority of babies who develop jaundice will be jaundiced when they are seen in their pediatrician's offices (or other clinics) several days after birth. Thus the use of noninvasive bilirubin determinations will not be restricted to the hospital, will likely find as much or more use in the outpatient population. As there are 132,418,000 babies born annually throughout the world (1996 data from UNICEF) it is reasonable to assume that about 90% or 119,176,200 annually will be potential subjects for a bilirubin determination. This does not strike me as being an "extremely limited" market." <<DIRECT is the same as CONJUGATED and INDIRECT is the same as UNCONJUGATED>> Again from Message 4821970 : 6. CCSI's Colormate like other colorimeters, can only be used to estimate the total amount of bilirubin in the blood. It does not estimate indirect or direct bilirubin levels which are necessary and are commonly provided by blood tests. Dr. Maisels' response is: "This statement is partly false and certainly misleading. It is true that this instrument provides an estimate of the total bilirubin. In the overwhelming majority of babies in the newborn nursery and those followed after discharge from the hospital, measurements of direct bilirubin levels are unnecessary. All of the current recommendations for management and treatment of jaundiced infants (including the use of phototherapy or exchange transfusion) are based on total bilirubin levels and not indirect bilirubin levels. Measurements of direct bilirubin levels are only needed when there is a suspicion of cholestatic (obstructive) jaundice and are of no relevance until the baby is at least 2-3 weeks old."(4)

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