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 In as many as 40 cases, women who took Sequenom Inc's MaterniT21
test, which scans their genetic code and that of their fetus, had
abnormal changes that could signify cancer. In at least 26 of these
women, that test turned out to be accurate.
Such tests from Sequenom and other companies, sequence the mother's
blood, which includes both the mother's DNA and fetal DNA from the
placenta. The unintended detection of disease lends weight to the
idea that some cancers can be traced through non-invasive tests,
when tumors shed their DNA into the bloodstream.
Dr. Eunice Lee, 40, a San Francisco anesthesiologist, was one of
those women.
Speaking at the Scripps Future of Genomic Medicine Conference, Lee
said she was hoping for a normal result for her baby. Instead,
Sequenom advised her to seek cancer screening. A full body MRI
identified a large tumor in her colon, which doctors removed in the
15th week of her pregnancy.
Sequenom's chief scientific officer, Dr. Dirk van den Boom, said the
company is gathering data on the other women whose tests indicated
abnormalities. So far, he said he is not aware of any false positive
results.
Other researchers have had similar findings. Scientists at the
University of Leuven in Belgium developed a blood test for signs of
Hodgkin's lymphoma after detecting the illness in pregnant women.
Dr. Diana Bianchi of Tufts University said the noninvasive prenatal
tests represent the "biggest clinical implementation of genomic
medicine to date," with more than 1 million having been performed
since 2011. Other companies offering such tests include Illumina,
privately held Natera and Ariosa Diagnostics, acquired by Roche in
December.
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Most often, DNA from the mother comes from bone marrow, but if she
has cancer, it may also be coming from her tumor.
Such results are raising ethical concerns. Lee said she was not told
that the test might identify a cancer. Van den Boom said the company
has struggled about what to do with such results, but favors
disclosing the information.
Bianchi said there is "pressing need" for guidance on how to
disclose unforseen findings discovered by prenatal tests, noting
that there no professional guidelines on how to deal with them.
(Reporting by Julie Steenhuysen; Editing by David Gregorio)
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