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Natera Launches Noninvasive Prenatal Test; Quest to Offer in Limited Areas by March, Nationwide in April

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Quest Diagnostics has agreed to distribute Panorama, Natera's noninvasive targeted SNP sequencing-based test to diagnose fetal aneuploidies, following Natera's announcement of the commercial launch of the test this week.

According to the two companies, Quest will offer the opportunity to its physician clients to send samples to be forwarded to Natera's CLIA-certified lab for testing. Quest will offer the test in a limited number of states in March and then nationwide in April.

“The broad availability of the test through Quest Diagnostics, a leader in women’s health diagnostics, will help many more women and parents access DNA-based noninvasive prenatal screening," Matthew Rabinowitz, Natera's CEO, said in a statement.

Natera's Panorama test uses a targeted sequencing approach to analyze 19,500 SNPs in order to identify trisomies 21, 18, 13 and sex chromosome abnormalities, such as monosomy X (CSN 11/14/2012).

Currently the company uses the Illumina HiSeq for its sequencing, but has said that its core technology, based on SNP detection and bioinformatics, is platform independent.

In a presentation at the annual meeting of the Society for Maternal-Fetal Medicine in San Francisco earlier this month, Natera shared data showing Panorama achieves greater than 99 percent sensitivity for trisomy 21, trisomy 18, and trisomy 13, and 92 percent sensitivity when detecting monosomy X. The test has also demonstrated 100 percent specificity for all the syndromes tested in the company's clinical validation studies.

According to the company, in addition to the chromosomal abnormalities the test currently covers, Panorama may also be applicable to aneuploidies like monosomy 21; 47,XXX and 47,XYY; and uniparental disomy and triploidy.

Panorama enters the market as a rival to a handful of other noninvasive prenatal tests, including market leader Sequenom's MaterniT21; recent Illumina acquisition Verinata Health's Verifi; and Ariosa Diagnostics' Harmony Prenatal Test.

Currently, all four companies are involved in lawsuits with one another. Sequenom has sued Ariosa, along with Verinata and Natera, claiming the companies infringe on its central patent. Ariosa, Verinata, and Natera are also suing Sequenom for being overly broad in its enforcement.

Additionally, in October, Verinata sued Ariosa, claiming it infringes a patent it licensed from Stanford's Stephen Quake.

Meantime, Ariosa has secured Laboratory Corporation of America as its distribution partner, while PerkinElmer has agreed to distribute Verinata's test.

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