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ILMN Expands Prenatal Test Offering

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Verinata Health, a wholly owned subsidiary of Illumina, Inc. (ILMN), introduced a new test option for its non-invasive verifi prenatal test. Physicians will now be able to use the test on women pregnant with twins. This is applicable either way, for conception through natural or assisted reproductive methods. The twins option for the verifi prenatal test will be accessible to physicians Oct 21 onwards.

The verifi prenatal test for twins is designed to detect serious abnormalities like those of Trisomy 21 (Down syndrome), Trisomy 18 (Edwards syndrome), and Trisomy 13 (Patau syndrome) and the presence of a Y chromosome in the fetuses.

The verifi prenatal test was authenticated using a large twin population study that covered around 100 maternal samples, more than any other non-invasive prenatal test (:NIPT) method. NIPT tests DNA present in a pregnant woman’s blood to detect fetal chromosome anomalies.

Among the commonly noted abnormalities, Trisomy 21 is the most prevalent at-birth aneuploidy, and a frequent cause of mental retardation. Others, including Trisomies 13 and 18, are associated with significant clinical morbidity and a high neonatal mortality rate. The majority of chromosomal aneuploidies are non-viable, leading to early miscarriage, while some may continue into the post-natal period and beyond.

The new test makes use of algorithms validated through an analysis of 115 maternal plasma samples from twin pregnancies, with all instances of aneuploidy detected. The verifi prenatal test with twins option successfully detected all cases of Down syndrome (trisomy 21) and Edwards syndrome (trisomy 18) in the samples. The test also revealed the samples which indicated the presence of the Y-chromosome.

Armed with algorithms that optimize detection of chromosomal abnormalities, the verifi prenatal test has the ability to deliver lower fetal fraction in twins. This ensures greater accuracy and reliability of results, and a resulting industry-low, test failure rate of 0.07%.

Twin pregnancies are on the rise in U.S., as studies showed that twins account for almost 1 among 30 live birth-pregnancies. The National Center for Health Statistics estimated an increase of 76% in twins-birth between 1980 and 2009.

It has been further observed that as a woman ages, chances of releasing more than one egg per menstrual cycle also increase. As the current generation becomes increasingly focused on their jobs and careers, family planning begins at a later stage than before.

As a result, women above 30 account for one-third of twin pregnancies. Assisted reproduction techniques, where more than one embryo is often transferred into the womb following in vitro fertilization, account for much of the remaining rise in twin pregnancies.  

Under such circumstances, an expanding patient population (women pregnant with twins) will help Illumina to garner growth going forward. This newly added feature of early identification of abnormalities in twin fetuses will provide parents sufficient time in advance to consider reproductive options.

ILMN currently carries a Zacks Rank #3 (Hold). Other stocks that are worth a look include Actelion Ltd. (ALIOF), Alexion Pharmaceuticals, Inc. (ALXN) each carrying a Zacks Rank #1 (Strong Buy) and Qiagen NV (QGEN), carrying a Zacks Rank #2 (Buy).

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