By Monica Heger
This story, originally published Aug. 11, has been updated to include comments from TrovaGene co-founder Gabriele Cerrone.
Sequenom has licensed technology to GATC Biotech subsidiary LifeCodexx to develop a sequencing-based trisomy 21 prenatal diagnostic test in Europe, the companies said last week.
Separately, molecular diagnostic company TrovaGene said it has regained the rights to patents it had previously licensed to Sequenom covering "transrenal technology for noninvasive prenatal applications and cancer."
Under the five-year agreement between Sequenom and LifeCodexx, the companies will develop and launch tests to diagnose trisomy 21 and potentially other aneuploidies in Germany, Austria, Switzerland, and Lichtenstein initially, but potentially in other countries as well.
The license is for European Patent EP0994963B1 — the European version of US Patent No. 6,258,540 titled "Non-invasive prenatal diagnosis," held by Dennis Lo of the Chinese University of Hong Kong and licensed by Sequenom — as well as for pending application EP2183693A1.
The agreement "provides a stepping stone for us into the European marketplace," Marcy Graham, Sequenom's director of investor relations, told Clinical Sequencing News. She added that after doing commercial studies, Sequenom concluded that partnering with a European firm was the "most efficient way" to enter the European market.
Additionally, Graham said that the agreement "validates the strength of our IP position because we were able to license it out."
At least one analyst, Oppenheimer's David Ferreiro, agreed, writing after the agreement was announced that it is "further validation of [Sequenom's] dominant IP position."
There have been questions surrounding the patent rights, particularly as several companies are planning launches of prenatal trisomy 21 tests by 2012, including Sequenom, LifeCodexx, and Verinata Health.
Last month, Sequenom said that it believed competitors would have to license technology from it in order to develop and launch a sequencing-based trisomy 21 test (CSN 7/27/2011).
"Some folks speculated that LifeCodexx would be a competitor, so [this license agreement] eliminates that concern," Graham added.
Verinata Health is also planning to launch a sequencing-based trisomy test either late this year or early next year, and will likely compete with Sequenom.
While Verinata's test is based on technology licensed from Stanford University, Sequenom's CEO Harry Hixson has said that he believes Verinata is infringing on its '540 patent (CSN 5/10/2011).
Under the terms of the deal between Sequenom and LifeCodexx, the latter will make undisclosed upfront and minimum annual royalty payments to Sequenom, as well as royalties based on the sales of testing services. Additional terms were not disclosed.
Graham said that the agreement would not impact the launch of the company's MaterniT21 test, still planned for late 2011 or early 2012.
Separately, molecular diagnostic company TrovaGene said last week that it has regained a patent right for prenatal testing from urine samples from Sequenom. Graham said that the TrovaGene patent is unrelated to the patent Sequenom holds for its MaterniT21 test and would have no impact on the launch of the test.
In a statement, TrovaGene said that it has recently used next-generation sequencing to show that fetal DNA is also present in the urine of pregnant women. Additionally, it said that it has begun discussions with several companies "whose analytical technologies are synergistic to short transrenal DNA fragments in urine," which would complement TrovaGene's "proprietary nucleic acid extraction and processing methodologies."
Gabriele Cerrone, a co-founder of TrovaGene, told CSN that the company is now working on developing a sequencing-based test that would detect trisomy 21 from the urine of pregnant women.
He declined to provide a time frame for when a test would be developed and also what sequencing platforms the company is considering for its test. Cerrone said that the company first needs to raise additional funds for the development of its test, including for clinical trials.
TrovaGene does not currently have next-gen sequencing capabilities in-house, and Cerrone said that depending on funding it would either seek to purchase a sequencer or partner with a separate organization.
David Robbins, TrovaGene's vice president of research and development, added in the statement that the company believes that combining the right analytical methods with transrenal DNA fragments from urine will allow the company to be "extraordinarily competitive within this prenatal screening market in terms of cost and time to result while maintaining high clinical sensitivity and specificity."
Cerrone told CSN that the patent that Sequenom returned is very broad, covering the "detection of small DNA fragments in urine to detect dozens of diseases. ... It opens the way for us to pursue and develop a Down syndrome test."
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