Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

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

To: THESTOCKMAN who wrote (4969)	3/21/1999 4:26:00 PM
From: JanyBlueEyes	Read Replies (2) \| Respond to of 5736

Mom Develops Infant Jaundice Test search.washingtonpost.com By Phil Galewitz AP Business Writer Sunday, March 21, 1999; 2:11 p.m. EST NEW YORK (AP) -- Darby McFarlene watched nurses draw blood from her newborn's feet and head every day for six weeks to monitor a common but potentially dangerous condition called jaundice. Bothered by the pain that her baby Scarlett had to endure 13 years ago, McFarlene went out and developed a noninvasive jaundice test. After nearly a decade in testing, her Colormate TLc (tender loving care) BiliTest cleared its final regulatory hurdle last month and is now being sent to hospitals and physicians nationwide. ''It's a victory for Dr. Mom,'' said McFarlene, president of Chromatics Color Sciences International Inc., which makes the handheld diagnostic device. Developing the test for jaundice -- a condition characterized by the yellow tint it gives to skin -- was a natural step for her 15-year-old-New York City-based company, which specializes in measuring colors for the cosmetics and health industries. About 60 percent of the 4 million babies born annually in the United States become jaundiced in the first three or four days after birth, and it is the most common cause of newborn readmission to hospitals. Nearly all premature babies are born with the condition, which can cause brain damage. The severity of jaundice is determined by the level of bilirubin in the blood. Bilirubin, which is produced naturally by the breaking down of the body's red blood cells, often builds up faster than a newborn's liver can break it down for the body to get rid of. While the problem usually corrects itself after a few days in most babies, some like Scarlett McFarlene have to endure weeks of evaluation and treatment. A blood test has been the standard bilirubin test for decades. While some attempts at a noninvasive test were tried before, none were accurate enough to replace the traditional test. The TLc test, though, has proven 95 percent accurate, compared to traditional blood tests, according to a study published in the Pediatrics medical journal last September. ''It should make a big difference,'' said Dr. Alan Greene, a pediatrician in San Mateo, Calif., who also runs a pediatric Web site. The noninvasive test will ensure that more babies get tested and speed up the time it takes for doctors to get results from a several hours to a few minutes, he said. ''This device will be extremely welcomed,'' said Dr. James Lemons, a neonatologist at Indiana University Medical Center and chairman of the American Academy of Pediatrics' fetus and newborn care committee. The TLc device costs between $3,000 and $5,000 depending on the model, and then each test cost about $10, about the same as a blood test, McFarlene said. The test uses a small light sensor that measures the yellow pigment in the baby's skin. The more yellow the skin, the higher the bilirubin level. The key to the device is that it can account for more than 210 different natural skin color types, and the effect on skin color change from light therapy, which is the most common treatment for jaundice. McFarlene was able to develop the new test because Chromatics already had much experience using computers to get precise measurements of colors. Chromatics, for example, has worked with Clairol in developing hair coloring and also with Avon's cosmetic products. The company also was aided by researchers at Mt. Sinai Hospital in New York City which spent more than a decade conducting studies on the device. Chromatics is hoping the jaundice test will help restore it to profitability. The publicly traded company lost $5 million in 1997 on revenues of only $250,000. The company estimates about $330 million is spent annually in the United States on blood tests for jaundice. More than 2,000 newborns were tested on the device before it won approval from the federal Food and Drug Administration. Though the device was approved in 1997, it took until earlier this year for the company to get its manufacturing process approved. ''All parents prefer not have their baby stuck,'' said Dr. Ian Holzman, chief of the division of newborn medicine at Mt. Sinai Hospital and chief investigator of the TLc studies at the facility. The test does not totally eliminate the need for newborns to get blood tests, which are required by state and federal government to test for an assortment of maladies and birth defects. Rather, the test will be most helpful for newborns whose level of jaundice requires treatment, and thus need to be monitored for days or weeks. McFarlene hopes to use the technology behind the jaundice test to develop noninvasive tests for other medical conditions, such as skin cancer, thyroid disorders and sickle cell anemia. © Copyright 1999 The Associated Press

To: THESTOCKMAN who wrote (4969)	3/21/1999 5:09:00 PM
From: Cacaito	Read Replies (1) \| Respond to of 5736

TheStockman, where I come from (the Caribbean)we have all kinds of skin tones, and nobody have ever turn ashy or bleached. Just darker (or red). Phototherapy heat radiation is minimal under NICU circumstances, the light panels have a fan to keep then cool at all time, the distance of the lights to the baby is also control (18 inches), and babies are in Isolettes to further regulate temperature and humidity (to decrease skin evaporation). Changes in skin color are not frequently drastic, but subtle. Please, provide the link or reference to Dr Maisels bleaching statement, I would like to know what does he mean about it. Anyway sprx will figured out how to deal with the "bleaching" whatever that is. I did not mentioned the thousand plus kids in the Elmhurst study? my point and very clear: CCSI did test only 61 kids on phototherapy. The pre-phototherapy ones are irrelevant, sprx bilicheck is already approved for that group. (anyway I provided the link to the abstract). Nicus and newborn nurseries are the almost only market for this devices (Colormate and Bilicheck). Babies in the first 1 week of life are the probable patients, minimal if any use in other populations. One could make the case for a pediatrics ER, clinic or practice group to have it if the device cost were $50, but the cost is $3,000. To charge for the cost of each test is cumbersome at best (try to get an HMO to pay). If Nicus are not a priority for Sprx then call the CEO again, his strategy is worth zero. Before, in this board, many claimed that Sprx will be FDA approved in years if at all. Well, they are out in the market, and with the Respironics big salesforce power most probably Sprx will get in Nicus faster than CCSI. Now the claim is it will take years to get the "phototherapy" label. I would not count on that.