NEW YORK (GenomeWeb) – German genetic diagnostic laboratory Cenata said this week that it is temporarily outsourcing its Harmony noninvasive prenatal test to Medirex, a laboratory in Slovakia, in response to a patent lawsuit brought against it late last year in Germany by Illumina and Sequenom.
From now until March 2018, when the patent in question expires, Cenata will have all its Harmony tests performed by Medirex, which is based in Bratislava. Cenata licenses the Harmony test technology from Roche's Ariosa and has been offering the test from its Tübingen laboratory since 2015.
Cenata Managing Director Dirk Biskup said that Illumina and Sequenom filed suit against Cenata and Roche in the District Court Mannheim in December of 2016, claiming that both companies are infringing European Patent EP 0994963 B2, titled "Non-invasive prenatal diagnosis." The patent is valid in a number of European countries, but apparently not in Slovakia, which is a member of the European Union.
The suit is still pending, but according to Cenata, a judge said during a hearing before the court that performing the Harmony test in a country not covered by the patent would be permitted.
"With this solution, we can continue to offer the original Harmony test in Germany and to our partners abroad – and all of this at the same quality, at the same price, and with the same turnaround time of two to four days," Biskup said.
He added that Roche Diagnostics filed an action for revocation of the patent with the German Federal Patent Court last November, which is expected to be decided in April 2018.
Cenata said that Medirex is certified and licensed by Ariosa and Roche Diagnostics to perform the Harmony test. The laboratory is accredited in accordance with ISO 9001 and 15189 and is CLIA-certified and CAP-accredited.
Going forward, patients whose doctors request the Harmony test from Cenata need to consent to the test being performed by Medirex. Cenata said that the test results will continue to be evaluated by physicians at Cenata.
Illumina and Sequenom have been suing several providers of NIPT in Europe since 2015, alleging infringement of a number of patents held by the companies. Earlier this week, Illumina filed a new patent suit against Premaitha Health in the UK over European Patent (UK) 1 524 321 B2. However, Biskup said that the suit against Cenata only involves the EP 0994963 B patent.