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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI
CCSI 22.82+0.3%12:59 PM EST
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To: Mama Bear who wrote (3323)6/22/1998 5:30:00 PM
From: Steve  Read Replies (2) of 5736
 
Here is the problem with CCSI's bilirubin screening test:

Jaundice occurs in 50% of all newborns and reflects an accumulation of bilirubin in the blood and other tissues. In most cases this resolves within a couple days without any treatment.

Bilirubin exists in two forms, CONJUGATED and UNCONJUGATED. The TLc-BiliTest from Chromatics only measures the total bilirubin (conjugated + unconjugated = total bilirubin).

The initial evaluation of an infant that is jaundice is to measure the conjugated and unconjugated concentrations of bilirubin. This can only be done with a blood test. You have to know both levels of bilirubin because depending on which one (conjugated or unconjugated) is elevated that determines your next step in the work-up of the patient.

The point is that a doctor already knows the baby is jaundice just by looking at him, he does not need a device to tell him that. The doctor's next question he needs answered is which type of bilirubin is elevated, conjugated or unconjugated. Knowing the total bilirubin, which is what the TLc-BiliTest does, is useless. The doctor must order a blood test.

This is why CCSI has not been able to sell one single device to a hospital in the U.S. in the past year.

I'm sure the TLc-BiliTest works but the information it gives the doctor is essentially useless. Once a doctor got the reading from the TLc-BiliTest he would then have to do a blood test.
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