personalized medicine
Personalized Medicine Company Wins Nebraska Governor's Bioscience Award
Omaha-based Transgenomic, which provides biotechnology products and services globally to advance personalized medicine, is the winner of the 2013 Nebraska Governor’s Bioscience Award. Gov. Dave Heineman presented the award Tuesday to Transgenomic President and CEO Craig Tuttle at the Bio Nebraska Life Sciences Association annual meeting, held at the Gallup Corporation’s Omaha campus. “Transgenomic is an example of the life science gems we have in our state,” Heineman...
National Health Service in UK Debuts New Multi-gene Cancer Diagnostic
The National Health Service, a publicly-funded healthcare system in the United Kingdom, announced that it adopted a new multi-gene sequencing system to help predict cancer patients’ responses to treatment. According to a press release by Oxford, the multi-gene test can detect mutations in 46 different genes that are associated with the growth of cancerous tumors. By determining which mutation of a gene is present in a patient, healthcare providers can choose the most-appropriate...
FDA Greenlights Two Dako Assays as Companion Dx for Genentech Cancer Drug Kadcyla
Dako, an Agilent Technologies Company and provider of cancer diagnostics, announced that it has received FDA approval for the addition of Kadcyla in the labeling of two of its companion-diagnostic assays. Kadcyla (ado-trastuzumab emtansine) is Genentech’s new therapy for patients with HER2-positive metastatic breast cancer who have received prior treatment with Genentech’s cancer medicine Herceptin (trastuzumab) and a taxane chemotherapy. The two assays are Dako’s...
The Personalized Medicine Revolution Is Near
The personalized medicine revolution is almost here, writes Narges Bani Asadi in a guest blog post on venturebeat.com. The founder and CEO of Bina Technologies, Asadi notes that "we are moving from the inefficient and experimental medicine of today toward the data-driven medicine of tomorrow . . . when diagnosis, prognosis, treatment and, most importantly, prevention will be tailored to individuals' genetic and phenotypic information." Much has been accomplished—DNA ...
Companion Diagnostics: Will the Final Guidance Resolve Anything?
Glen P. Freiberg, RAC The CDRH 2013 Strategic Priorities indicates that the companion diagnostic final guidance will be published by the end of March. Without specific linkage to reimbursement, the guidance will not solve a main problem it attempts to address.   The reason is that even with a cleared or approved companion diagnostic, plus therapy labeling that requires an FDA-approved or -cleared companion diagnostic, there is nothing stopping CLIA-certified labs from creating...
The Awkward Dance of Pharma and IVD on the CoDx Floor
  You can’t get away from personalized medicine, Harry Glorikian told attendees at the Evolution of Advanced IVDs conference in San Diego this week. “Everyone is on board . . . it’s unprecedented . . . but there is no alignment. Pharma and IVD companies are in an awkward dance . . . the system is broken,” said Glorikian, founder and managing partner of Scientia Advisors.   The disconnect between pharma and IVD companies in the companion diagnostics (CoDx) space...
Personalized Medicine Meeting This Week in San Francisco
The 8th annual Burrill Personalized Medicine Meeting takes place this Thursday and Friday, September 13 and 14, in San Francisco. The meeting will provide attendees with a "window into this personalized medicine world, from where the science had led us to what hurdles need to be overcome and the policies that are required so that personalized medicine becomes a more widely adopted part of our approach to addressing global health issues," according to the organizer, Burrill &...
Saladax Biomedical, Bristol-Myers Squibb Sign Master Collaboration Agreement
Is it one (more) small step for personalized medicine? Saladax Biomedical announced today that it has expanded its existing relationship with Bristol-Myers Squibb by signing a Master Early Development Collaboration Agreement. The contract, which may include multiple feasibility studies and companion diagnostic development projects, comes as the companies have initiated a new companion diagnostic project in an undisclosed field. The two companies intially entered into a collaboration in 2010 for...
MolecularMD Submits PMA Application for Its Companion Dx to Ponatinib for Chronic Myeloid Leukemia
MolecularMD Corp. has submitted its application for premarket approval of its MolecularMD BCR-ABL T315I Mutation Test. This test detects the T315I mutation in BCR-ABL RNA transcripts in blood using Sanger sequencing technology. The MolecularMD test can be used to identify patients with chronic myeloid leukemia (CML) and Philadelphia positive acute lymphoblastic leukemia (Ph+ ALL) who have the T315I mutation; the test is intended as a companion diagnostic to ponatinib. Ponatinib, a BCR-...
PrimeraDx, Lilly to Partner on Novel Personalized Therapeutics
A Massachusetts-based molecular diagnostics company will partner with Eli Lilly and Co. to develop programs to support novel therapeutics. PrimeraDx says it will use its ICEPlex system in collaboration with Lilly to develop innovative multiplex assays during the “multiyear” agreement. The assays combine PCR and capillary electrophoresis in a benchtop instrument designed to rapidly configure complex multimodal assays for targets such as SNPs, expression biomarkers, and fusion genes...