Case 1:20-cv-01644-RGA Document 1-17 Filed 12/03/20 Page 1 of 3 PageID #: 868
`Case 1:20-cv-01644-RGA Document 1-17 Filed 12/03/20 Page 1 of 3 PageID #: 868
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`EXHIBIT 17
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`EXHIBIT 17
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`5/27/2020
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`A�shot in the arm keeps�fetuses safe - Sep. 12, 2007
`Case 1:20-cv-01644-RGA Document 1-17 Filed 12/03/20 Page 2 of 3 PageID #: 869
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`A better prenatal test?
`A biotech startup promises accurate prenatal tests without the risks of traditional
`amniocentesis.
`
`By Lisa Palmer
`September 12 2007: 7:02 AM EDT
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`(FSB Magazine) -- Life was proceeding as planned for Ravinder Dhallan, or so it seemed. Having earned doctorates in
`medicine and biomedical engineering at Johns Hopkins University, he had just started a radiation oncology residency at
`Massachusetts General Hospital. On the home front Dhallan and his wife, Hejung Christine Chang, had a daughter, and
`they were eager to see their family grow.
`Then things got complicated. Chang suffered two miscarriages. The couple was devastated and had no idea what to do.
`Only later did they realize that the miscarriages had a genetic basis. The episode left Dhallan struck by how little
`information was available to women who experienced complications during pregnancy. "It suddenly became personal," he
`says. And so he resolved to invent a better prenatal diagnostic exam.
`Dhallan had long dreamed of solving a scientific problem and building a business
`around his discovery. That's an uncommon trait in the highly structured world of
`modern medicine. Every year enterprising MDs come up with ingenious new
`therapies. But few doctors are willing to trade their medical careers for the risks
`of a startup.
`Dhallan's venture seemed particularly chancy. His goal was a test to detect fetal
`abnormalities such as Down syndrome and cystic fibrosis at an early stage in a
`pregnancy (so there's enough time for the fetus to be treated or aborted safely). It
`was no easy task. Currently the diagnostic gold standard is amniocentesis, in
`which a four-inch needle is inserted into the abdomen to extract amniotic or
`placental cells directly from the womb. The results are 100% accurate, but the
`test carries a one-in-200 risk of triggering a miscarriage and can't be performed
`until the pregnancy is 15 to 18 weeks along. An alternative, chorionic villus
`sampling, can be performed ten to 12 weeks after conception but poses a greater
`risk of miscarriage.
`Meanwhile, today's noninvasive prenatal screenings options rely on a
`combination of ultrasound imaging and blood samples drawn 11 and 16 weeks
`into the pregnancy. Accuracy rates range from 60% to 90%, and about 5% of
`tests produce false positives.
`What has made detecting genetic problems in a fetus so difficult thus far is that
`you need a test that can distinguish fetal and maternal DNA. Think needle in
`haystack: One vial of a pregnant woman's blood contains billions of copies of her
`own DNA mixed with just a few hundred copies of her baby's DNA.
`Dhallan's patented procedure, called Rapid Analysis of Variations in the Genome,
`draws 29.5 milliliters (or a mere two tablespoons) of blood from the mother's arm, isolates fetal DNA cells, and checks
`them for three copies of chromosome 21, the marker for Down syndrome. The test is 99% accurate, according to his
`published studies, and can be performed after the eighth week of pregnancy. He is now working to extend the test to
`detect cystic fibrosis.
`Dhallan has incorporated a biotech firm called RavGen (ravgen.com), based in Columbia, Md. He has raised $15 million
`for research and development and has completed two clinical trials of RavGen's prenatal screen. Dhallan is now
`recruiting clinicians and their patients for the third and last clinical trial. His test will then go up for approval from the U.S.
`Food and Drug Administration. He hopes to have a test on the market in the next few years.
`Dhallan's timing is impeccable. The number of women giving birth after age 35 - the highest-risk group for Down
`syndrome - is increasing at a rate of 1.5% each year. Last January the American College of Obstetrics and Gyne-cology
`recommended that all pregnant women be screened for Down syndrome. The occurrence of the syndrome has held
`steady over the past few years at one in every 800 to 1,000 U.S. births.
`How did Dhallan manage the transition from physician to entrepreneur? Part of the answer lies in his medical training.
`After deciding to launch RavGen, he left oncology for emergency medicine, hoping that a schedule of long-er days and
`shorter workweeks would free up time to focus on his business. But the emergency room turned out to be great training
`for the daily high-wire act of running a startup. "You get perspective," says Dhallan. "Once you've dealt with life and death
`day in and day out, other problems seem trivial." The ER also helped him develop strong leadership skills. "If someone
`has been shot six times, everyone is looking at the physician's response," Dhallan says. "If I didn't look confident, then
`everyone would lose confidence."
`On free days Dhallan read about prenatal medicine and picked the brains of entrepreneurs in many fields. "One guy had
`a concrete company," says Dhallan. "Another was a builder. I asked them how they incorporated. Who was their
`accountant? What law firm did they like?" Like many other successful entrepreneurs, Dhallan surrounded himself with
`smart people. Most of his 20 employees are scientists. His board includes a Nobel laureate and several medical experts
`affiliated with Johns Hopkins University in nearby Baltimore. To retain control of his young company, Dhallan raised
`capital from long-term angel investors, avoiding venture capitalists and strategic partners. One of his first investors was a
`college buddy; another, a childhood friend.
`Dhallan faces stiff competition. Some 15 research teams worldwide are seeking a solution for safe, reliable, noninvasive
`alternatives to amniocentesis, says Dr. Jacob Canick, director of prenatal and special testing at Women & Infants
`Hospital in Providence. One rival, Dr. Dennis Lo of the Chinese University of Hong Kong (cuhk.edu.hk), describes
`Dhallan's research as promising but inconclusive. "I was very excited, but our researchers were unable to replicate his
`work in the lab," Lo says.
`Dhallan isn't fazed. In 2004 he pub-lished his technique in the weekly Journal of the American Medical Association. A
`second paper appeared in the February issue of The Lancet, a British medical journal. And he is launching his largest
`random, double-blind study yet. On the business side, Dhallan earned an MBA at the University of Pennsylvania's
`Wharton School. Rav-Gen will soon announce a partnership with a well-known ultrasound company. "This will help our
`brand gain traction faster," he says.
`
`https://money.cnn.com/2007/09/07/smbusiness/amniocentesis.fsb/index.htm
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`5/27/2020
`A�shot in the arm keeps�fetuses safe - Sep. 12, 2007
`Case 1:20-cv-01644-RGA Document 1-17 Filed 12/03/20 Page 3 of 3 PageID #: 870
`The news from home is equally good. After ten years of reproductive challenges, Dhallan's wife gave birth to their second
`child, a son. Matthew Dhallan is now 2 years old and thriving.
`
`Will Congress slam small inventors?
`A mother's race for a cure
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`To write a note to the editor about this article, click here.
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`https://money.cnn.com/2007/09/07/smbusiness/amniocentesis.fsb/index.htm
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