Case 1:20-cv-01644-RGA Document 1-19 Filed 12/03/20 Page 1 of 3 PageID #: 875
`Case 1:20-cv-01644-RGA Document 1-19 Filed 12/03/20 Page 1 of 3 PageID #: 875
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`EXHIBIT 19
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`EXHIBIT 19
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`5/27/2020
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`Experimental Prenatal Test Helps Spot Birth Defects
`Case 1:20-cv-01644-RGA Document 1-19 Filed 12/03/20 Page 2 of 3 PageID #: 876
`Experimental Prenatal Test Helps Spot Birth Defects
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`By Amanda Gardner
`HealthDay Reporter
`Friday, February 2, 2007 12:00 AM
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`FRIDAY, Feb. 2 (HealthDay News) -- A new, noninvasive method of prenatal testing may one day help to detect
`birth defects in unborn babies.
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`But it'll be a while before the technique comes to market.
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`"We've shown the first abnormality, and this is proof of principle to show that this technology can be a
`noninvasive test from maternal blood," said study author Dr. Ravinder Dhallan, founder and chief executive
`officer of Ravgen Inc., in Columbia, Md. "Next, we will do a larger study and start building the infrastructure to
`go to market."
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`Dhallan wouldn't speculate on when such a test might become commercially available, saying only, "We don't
`intend to rush it. The health of a baby is the most important thing in anyone's life, but we are moving with
`deliberate speed."
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`Dr. Michael Katz, senior vice president for research and global programs at the March of Dimes, called the
`experimental test a "good system if it can be sustained by more extensive tests. It also dovetails with the current
`suggestion by the American College of Obstetricians and Gynecologists that prenatal diagnosis should be
`applied to all women."
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`The study findings are published online Feb. 2 inThe Lancet.
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`Currently, tests to detect chromosomal abnormalities before a baby is born pose a number of problems.
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`Ultrasound is noninvasive but does require subsequent invasive testing before a final diagnosis can be made.
`And invasive diagnostic tests, such as amniocentesis and chorionic villus sampling, can pose risks to the
`pregnancy, including miscarriage.
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`"Even though the current invasive tests are quite safe, relatively speaking, they are invasive, and there are
`complications," Katz said. "Moreover, they have to be done somewhat later [in the pregnancy], and the sooner
`one makes this diagnosis, the better."
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`Scientists have known for several decades that fetal cells are present in the mother's blood as early as five weeks
`into the pregnancy. The problem is that the cells are extremely rare, representing only about one in a million of
`total cells.
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`The reason for their rarity? The mother's cells are very much like water balloons: From the moment blood is
`drawn, her cells burst and let loose maternal DNA into the blood stream. This serves to dilute the fetal DNA,
`Dhallan explained.
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`"Every time a mother's cell bursts, it dilutes the fetal DNA, particularly when you transport samples and when
`you centrifuge and process samples to get the DNA out of the plasma," he said.
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`In March 2004, Dhallan solved that problem in a study that showed that adding formaldehyde to the blood
`sample caused the mother's cells to harden ("like Ping-Pong balls"), reducing dilution and increasing fetal DNA
`to 25 percent.
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`The next challenge was how to distinguish maternal DNA from fetal DNA and how to identify abnormalities.
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`Experimental Prenatal Test Helps Spot Birth Defects
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`Case 1:20-cv-01644-RGA Document 1-19 Filed 12/03/20 Page 3 of 3 PageID #: 877
`For the new study, the researchers examined blood samples from 60 pregnant women and the "stated biological
`fathers," and analyzed single nucleotide polymorphisms (SNPs or "snips"), the tiny variations in the DNA
`sequence that exist between individuals.
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`There are about 3 million variable sites where human DNA differs from person to person, out of a total of 3
`billion base pairs. "The key is finding where they differ," Dhallan said.
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`Combining mathematics and genetics technology, the researchers determined the ratio (between mother and
`child) of SNPs on different chromosomes. That ratio should be the same for all chromosomes. "If it's not, you
`have a problem," Dhallan said.
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`The method correctly identified the number of chromosomes in 58 of 60 samples, including two cases of trisomy
`21 (which causes Down syndrome), Dhallan said. One case of trisomy 21 went undetected, while one normal
`sample was incorrectly identified as trisomy 21.
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`Katz said: "They have one mistake one way and one the other way. That's a little too risky if you compare this
`with invasive techniques where you have virtually 100 percent accuracy. Also, one can never be absolutely
`certain that this is the biological father. In addition, there may be some times when the father is not available."
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`A second study, this one appearing in the Feb. 3British Medical Journal, questions the rise of "boutique
`ultrasonography," where commercial companies offer "keepsake" scans to expectant parents without medical
`supervision.
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`Three- and four-dimensional, as well as moving images, can sell for up to $500, the study author stated.
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`While the companies claim the ultrasound poses no danger to mother or baby, several official organizations,
`including the American Institute of Ultrasound in Medicine and the U.S. Food and Drug Administration, have
`expressed concerns about the practice.
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`More information
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`To learn more about the types of prenatal tests that are currently available, visit the March of Dimes.
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`SOURCES: Ravinder Dhallan, M.D., Ph.D., founder and chief executive officer, Ravgen Inc., Columbia, Md.;
`Michael Katz, M.D., senior vice president for research and global programs, March of Dimes, White Plains,
`N.Y.; Feb. 2, 2007,Lancet, online; Feb. 3, 2007,British Medical Journal
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`© 2007 Scout News LLC. All rights reserved.
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