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Sequenom Files Preliminary Injunction Motion Against Aria

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Sequenom said last week that it has filed a motion for a preliminary injunction against Aria Diagnostics to stop the production and use of its sequencing-based test for detecting fetal chromosomal aneuploidy.

According to a statement, Sequenom wants to "stop Aria from making, using, selling, or offering for sale, importing, or exporting" tests that Sequenom claims infringe on a patent it holds until pending litigation is resolved.

The injunction request follows a suit Sequenom filed against Aria in January, claiming that its Harmony Prenatal Test infringes US Patent No. 6,258,540, to which Sequenom holds exclusive rights (CSN 1/25/2012).

Aria's Harmony Prenatal Test is a targeted sequencing-based test for the detection of trisomy 21 and trisomy 18, and Aria is planning to launch it from its CLIA lab in San Jose, Calif., in the second half of this year (CSN 1/18/2012).

Aria's test is an internally developed assay, which it calls digital analysis of selected regions, or DANSR, that targets 384 loci each on chromosome 21 and chromosome 18. Researchers from Kings College recently reported results from a nested case-control study of 400 pregnant women and Aria is also planning to launch a 25,000 person clinical trial (CSN 2/1/2012).

The targeted approach will make the test cheaper than Sequenom's MaterniT21 test, which it bills to payors at $2,700 and self-pay individuals at $1,900. Aria, meantime, is aiming for a sub-$1,000 test.

Sequenom is currently involved in legal disputes with a number of companies over its '540 patent.

Aside from Aria, Sequenom is also suing Natera, claiming Natera's noninvasive paternity test infringes on the '540 patent. Natera is also developing a sequencing-based trisomy test.

Sequenom has also said it will sue Verinata Health when it launches its sequencing-based trisomy test in March. Verinata uses a shotgun sequencing strategy very similar to Sequenom's approach. Verinata this week filed a pre-emptive suit seeking a declaration that its test does not infringe Sequenom's intellectual property and is also charging Sequenom with infringing several of its own patents (see story, this issue).

Additionally, both Aria and Natera have sued Sequenom, claiming the company is overaggressive in enforcing the '540 patent (CSN 12/21/2011).

Following news of the injunction motion against Aria, Oppenheimer analyst David Ferreiro wrote in a research note that "a future injunction against Natera would not [be a] surprise" and that while no legal action has been brought against Verinata yet, Oppenheimer "expect[s] an announcement shortly considering Verinata plans to launch its test in early March."

Despite the forthcoming competition to Sequenom's MaterniT21 test, Ferreiro said that Sequenom has a "defined first-mover advantage" and added that Verinata's recently published data in the American Journal of Obstetrics and Gynecology was "inferior" because the company's high sensitivity and specificity rates were "offset by a high no call rate."

Ferreiro reiterated Oppenheimer's 2012 expectations for Sequenom, estimating that the company will deliver 8,443 tests in the high-risk patient population, translating to $15.2 million in revenue. The firm expects that to increase to around 35,000 tests in 2013 for $64 million in revenue.

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