Roche Dx Submits Hepatitis C Viral Load Monitoring Test For FDA Approval
Roche Diagnostics announced this week it has submitted its automated test for hepatitis C viral load monitoring to the US Food & Drug Administration for review.
The FDA will review the application to determine whether the test can be safely marketed as a diagnostic in the United States. The test, called the COBAS AmpliPrep, or the COBAS TaqMan HCV Test, provides information about the level of hepatitis C virus in a patient's blood. The diagnostic “is a key measure of how well a patient infected with hepatitis C is responding to drug therapy,” the company said in a statement.
The current treatment for hepatitis C, often an asymptomatic infection of the liver, combines pegylated interferon and ribavirin drugs. The combination treatment can get rid of the virus in 50 percent of patients infected with genotype 1 of the virus and in 80 percent of patients infected with genotypes 2 and 3.
ABI, BG Medicine Team on Industrial-Scale Biomarker Research
Applied Biosystems and BG Medicine are partnering on a research project that will use ABI technology to develop methods for enhancing the scale of biomarker development, ABI said this week.
Under the terms of the two-year agreement, BG medicine will integrate ABI technology within its proteomic and metabolomic research pipeline, which BG terms “systems pharmacology.”
BG Medicine focuses on the molecular characterization of disease states and drug response and is already using ABI's mass spectrometers, software, and reagents "in an industrial setting," ABI said.
Under the current agreement, BG plans to use the same tools to expand the scale of ABI's biomarker discovery and proteomics and metabolomics technologies.
Making these advances "more relevant and applicable on a wider scale," said Laura Lauman, president of ABI's proteomics and small molecule division, “can help transform the process of drug discovery and development.”
Financial terms of the agreement were not released.
Roche Dx Licenses Multilyte’s Multiparameter Binding Assay IP
Roche Diagnostics said this week it has signed a licensing agreement with Multilyte for access to Multilyte's patents for diagnostic assays.
Roche will pay a license fee and royalties from the sale of products covered by Multilyte’s patents.
Assays covered under the patents include mulitparameter binding assays, including immunoassays, to enable “simultaneous detection and analysis of many different analytes in small test samples of biological origin,” Roche said.
Roche said that the agreement will enable it to develop microarray-based immunoassays and other binding assay systems that will detect multiple analytes in a single reaction.
Multilyte was founded in 1988 as a spin-off from University College London by UCL biophysics professor Roger Ekins.
Bayer Tech Partners with CHOP on Software for Personalized Drug Dosing
Bayer Technology Services is collaborating with Children’s Hospital of Philadelphia on a research project to develop individualized drug therapies for children, the company said.BTS will integrate its PK-Sim pharmacokinetic and pharmacodynamic modeling and simulation techniques with CHOP’s “Pediatric Knowledgebase” — an initiative to create a user-friendly computer interface that will present doctors with patient information and dosing history and use simulations to predict “expected trends in drug plasma concentrations,” the company said.
The end result will allow pediatricians to make drug dosing decisions that are tailored to each patient, BTS said.
The collaboration will “aim to demonstrate the usefulness of physiology-based modeling in guiding dosing decisions.” said Jörg Lippert, Head of the systems biology group of BTS, in a statement.
Digene Sues Third Wave for IP Infringement, Third Wave Disagrees
Digene sued Third Wave Technologies for allegedly infringing “unidentified claims” of one of its patents, and Third Wave said it disagrees.
The suit, filed in the US District Court for the Western District of Wisconsin, said Third Wave’s Invader technology infringes US Patent No. 5,643,715, which covers a type of human papillomavirus.
Third Wave said the patent relates only to HPV type 52, which it said is prevalent only in 0.5 percent of all HPV-positive cases in the US.
“We took great care to create a detection method free from the limited scope of the '715 patent's claims,” Third Wave President and CEO Kevin Conroy said in a statement.
Conroy added that its Invader chemistry “operates differently from any other nucleic acid analysis and is well protected by intellectual property rights of its own.”
Third Wave sued Digene in 2005 in an effort to get a court to support its right to sell its HPV diagnostic test. That suit was settled on Jan. 13, 2006, "without the grant of any license or freedom-to-operate under the patents-in-suit and without any effect on the patents-in-suit,” according to a statement released by Digene at the time.
Under that agreement, Digene said, the companies also agreed not to sue each other for one year. That deadline expired on Jan. 13.