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Sequenom Boosts Prenatal IP Portfolio with Helicos Patents; Raises MaterniT21 Sales Projections


By Monica Heger

Sequenom disclosed
last week that it has expanded its portfolio of prenatal testing intellectual property by purchasing two patent applications from Helicos BioSciences.

The IP, acquired for $1.3 million, covers methods for detecting fetal nucleic acids and diagnosing fetal abnormalities.

Additionally, the company this week pre-announced its first-quarter 2012 sales for its MaterniT21 Plus noninvasive sequencing-based laboratory developed test to diagnose trisomy 21, 13, and 18.

Sequenom said it sold more than 4,900 tests in the first quarter of 2012, which equates to an annualized run rate of over 30,000 tests, exceeding its previous guidance of 25,000 tests per year.

Of its decision to purchase the Helicos IP, Sequenom declined to comment, except to say that the patent applications are an "incrementally additive contribution to our suite of property."

The company already holds a broad patent in the space, US Patent No. 6,258,540, which is the subject of ongoing disputes involving Verinata Health, Ariosa (formerly Aria), and Natera, all of whom have launched or plan to launch sequencing-based trisomy 21 tests.

Sequenom has previously said that the '540 patent would cover any sequencing-based fetal trisomy test.

The Helicos patent applications, Serial Nos. 12/709,057 and 12/727,824, are more specific to using sequencing to diagnose fetal abnormalities and include sequencing of either DNA or RNA, single-molecule sequencing, and a range of detection methods, from optical methods to detect fluorescently labeled nucleotides to nanopore detection.

According to the '057 patent application, "methods of the invention take advantage of sequencing technologies, particularly single molecule sequencing-by-synthesis technologies, to detect fetal nucleic acid in maternal tissues or body fluids."

The claims cover detection of fetal abnormality using single-molecule sequencing, "wherein the single-molecule sequencing reaction comprises sequencing by synthesis or sequencing by nanopore detection."

Additionally, the patent applications site specific fetal abnormalities in their claims, including fetal aneuploidies and chromosomal aberrations.

Sequenom declined to disclose whether it has plans to eventually develop fetal diagnostic tests based on single-molecule sequencing. However, Illumina, with whom it has a supply agreement, does plan to develop single-molecule sequencing technology and also has a commercialization agreement with Oxford Nanopore for its exonuclease sequencing technology (IS 2/14/2012).

Sequenom currently runs the MaterniT21 Plus test on the HiSeq 2000. The company said this week that it has extended its supply agreement with Illumina from three years to five years, ending in July 2016.

MaterniT21 Sales

This week, Sequenom also pre-announced that it had sold more than 4,900 MaterniT21 Plus tests during the first quarter of 2012, and that it had increased its full-year sales goal to 40,000 from a previous target of 25,000.

Some analysts were not surprised by the increase, as they regarded the previous estimate of 25,000 tests for 2012 to be low. Brian Weinstein, an analyst with William Blair, wrote in a memo that the firm was not surprised, "as our latest survey indicates that volume continues to ramp up at a lighting fast clip." The firm forecasts 42,700 tests billed for the year.

Jon Wood, a Jeffries analyst, said that while sales of the test were encouraging, he would be interested in further guidance around reimbursement and the legal disputes with potential competitors.

The firm is "impressed with the volume ramp," he wrote. However, it views evidence around reimbursement and "greater clarity around competitive/IP-related issues, as critical in framing a more constructive view" on the company.

Have topics you'd like to see covered by Clinical Sequencing News? Contact the editor at mheger [at] genomeweb [.] com.

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