Roche said today it granted a worldwide license for its portfolio of emulsion PCR (emPCR) patents to Sysmex Inostics, a molecular diagnostics provider that has been using the technology in several of its tests.
Sysmex Inostics has used emPCR technology in several diagnostics, stretching back to 2009 when predecessor Inostics won an exclusive worldwide license from The Johns Hopkins University to detect PIK3CA mutations using techniques that include emulsion PCR.
In June 2013, it gained exclusive rights to use emPCR to determine mutations of the IDH1 and IDH2 genes, under an earlier agreement with Personal Genome Diagnostics (PGDx). That agreement allowed Sysmex Inostics’ predecessor company Inostics to launch the OncoBEAM multi-gene blood test for IDH1/2 mutations such as those found in several types of cancers, including early- and late-stage gliomas and acute myeloid leukemia (AML).
Sysmex Inostics is a subsidiary of German-based Sysmex, which acquired Inostics in October.
Sysmex Inostics offers OncoBEAM tests for some 20 cancer mutations as well as several multiple-mutation panels. The tests incorporate BEAM (Beads, Emulsions, Amplification, and Magnetics) technology, whose steps include emPCR – in which each DNA molecule is individually isolated within its own bubble in a water/oil emulsion that includes a capture bead and PCR amplification reagents.
While a million molecules may be prepared simultaneously, each molecule is individually amplified to a single bead, allowing for the equivalent of a million separate PCR reactions. The high-throughput technique is intended to produce significant cost savings over Sanger sequencing.
Sysmex Inostics is a clinical service lab that uses emPCR technology in predicting patients’ responses to drugs and monitoring cancer, by quantifying and analyzing the amount of free circulating tumor DNA in plasma in order to detect relapse and resistance mutations.
Roche’s non-exclusive, royalty-bearing license with Sysmex Inostics was one of two diagnostics initiatives disclosed today by the pharma giant.
Roche also said it was launching the fully-automated CINtec PLUS cytology test to improve detection and early intervention of pre-cancerous cervical disease – a test not yet available for use in the U.S.
CINtec PLUS is designed to help identify women whose Human papillomavirus (HPV) infections may lead to cancer – as well as distinguish them from those that will not. The test detects the presence of high-grade pre-cancerous cervical lesions in women who need an immediate colposcopy, such as patients with abnormal results from Pap smears.
According to Roche, a study published last year in Journal of the National Cancer Institute showed CINtec PLUS to be significantly more effective in detecting cervical pre-cancer than Pap smears. The test is available in Europe, Asia, Latin America and Canada.