Case 1:20-cv-01644-RGA Document 1-18 Filed 12/03/20 Page 1 of 4 PageID #: 871
`Case 1:20-cv-01644-RGA Document 1-18 Filed 12/03/20 Page 1 of 4 PageID #: 871
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`EXHIBIT 18
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`EXHIBIT 18
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`5/27/2020
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`BBC NEWS | Health | Hope for safe prenatal gene test
`Case 1:20-cv-01644-RGA Document 1-18 Filed 12/03/20 Page 2 of 4 PageID #: 872
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`Hope for safer foetus gene tests
`03 Mar 04 | Health
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`Last Updated: Friday, 2 February 2007, 01:05 GMT
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`Printable version
`Hope for safe prenatal gene test
`Work by scientists could
`lead to a non-invasive blood
`test to detect genetic
`abnormalities such as
`Down's syndrome in the
`womb.
`
`Current non-invasive tests -
`such as ultrasound - are limited,
`and invasive tests pose a risk to
`the pregnancy.
`
`The test may spot genetic abnormalities
`in the womb
`The new technique works by examining samples of foetal DNA
`present in the mother's blood for tiny variations in the
`sequence of the genetic material.
`
`US firm Ravgen Inc's work is detailed online by the Lancet.
`
`Experts say other approaches may also bear fruit.
`
`Being able to identify genetic
`abnormalities at an early stage
`not only gives parents the
`chance to decide whether or
`not to proceed with the
`Dr Lyn Chitty
`pregnancy, but also alerts
`University College London Hospital
`medical staff to the need for
`close monitoring right through to birth.
`
` Most people think one of
`these technologies will
`eventually be refined enough
`to be useful in clinical practice
`
`Analysing foetal DNA from a mother's blood sample has been
`possible for some time.
`
`However, its effectiveness has been limited because only a
`small amount of the DNA makes its way into the mother's
`blood.
`
`Characteristic pattern
`
`The Ravgen team, led by Ravinder Dhallan, has been able to
`maximise the amount of DNA that can be recovered by
`treating the blood samples with a chemical called
`formaldehyde.
`
`The researchers took blood samples from 60 pregnant women.
`
`They then searched the genetic material for variations known
`as single nucleotide polymorphisms (SNPs).
`
`As each chromosome has a characteristic pattern of SNPs, the
`researchers were able to distinguish between DNA from the
`mother and the foetus.
`
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`5/27/2020
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`BBC NEWS | Health | Hope for safe prenatal gene test
`Case 1:20-cv-01644-RGA Document 1-18 Filed 12/03/20 Page 3 of 4 PageID #: 873
`They were also able to determine whether the foetus was
`carrying extra copies of key chromosomes which cause genetic
`disease.
`
`For example, carrying an extra copy of chromosome 21 causes
`Down's syndrome (trisomy 21).
`
`Of the 60 samples tested, the technique identified the number
`of chromosomes correctly in 58, including two cases of trisomy
`21.
`
`One case of trisomy 21 was not identified, and one normal
`sample was incorrectly identified as being trisomy 21.
`
`However, the researchers stressed their work is at a
`preliminary stage, and further trials were needed to fine-tune
`the technique.
`
`New era
`
`Writing in the Lancet, Alexandra Benachi and Jean-Marc Costa,
`of Paris-Descartes University, said the test was promising, and
`"opens a new era in prenatal screening".
`
`However, they added: "Some technical issues still need to be
`overcome.
`
`"First, the amount of free foetal DNA in maternal blood is low,
`and although the use of formaldehyde allows an increased
`amount to be isolated from maternal blood, yields are
`irregular.
`
`"Second, Dhallan assessed only eight women in the first
`trimester - further testing in this stage of pregnancy will be
`essential."
`
`Dr Lyn Chitty, an expert in genetics and foetal medicine at
`University College London Hospital, said researchers were
`working on other methods to develop a non-invasive test.
`
`These include examining proteins in the mother's blood, and
`epigenetics - the study of spontaneous changes to the foetal
`DNA.
`
`She said: "Most people think one of these technologies will
`eventually be refined enough to be useful in clinical practice.
`
`"An accurate non-invasive test would mean a lot women with
`normal babies would not have to be put through a procedure
`like amniocentesis."
`
`Professor Maj Hulten, of the University of Warwick, founded a
`pan-European research network to work on new prenatal tests.
`
`She said the study was very interesting, particularly as regards
`the formaldehyde fixation of the blood samples, and with
`further refinement a non-invasive test is likely soon to become
`a reality.
`
`"I would be surprised if this approach alone turned out to be
`the one that wins the race to become clinically useful."
`
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`5/27/2020
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`BBC NEWS | Health | Hope for safe prenatal gene test
`Case 1:20-cv-01644-RGA Document 1-18 Filed 12/03/20 Page 4 of 4 PageID #: 874
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