A Diagnostics & Imaging Week
Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) and Vanda Pharmaceuticals (Rockville, Maryland) a biopharmaceutical company focused on the development of clinical-stage product candidates for central nervous system disorders, reported an exclusive alliance to develop and commercialize a series of diagnostic tests for genetic markers identified by Vanda in the course of its clinical development of Fanapta (iloperidone), a novel atypical antipsychotic drug candidate under FDA review for the treatment of schizophrenia.
Financial terms of the agreement were not disclosed.
Vanda has identified a series of pharmacogenetic markers during its development of Fanapta, and the company continues its pioneering work in this area. LabCorp will be Vanda's exclusive commercialization partner for tests for genetic markers of the Fanapta program.
"Working with innovative companies like Vanda to commercialize predictive medicine tests is a critical strategic focus for LabCorp," said Andrew Conrad, PhD, chief scientist and global head of clinical trials for LabCorp. "This collaboration is an example of our commitment to the advancement of personalized medicine and represents a successful translation of a research based assay into a valuable diagnostic test. This relationship is consistent with our focus on companion diagnostics."
In other agreements:
• Rosetta Genomics (Rehovot, Israel) is collaborating with the University of Texas M. D. Anderson Cancer Center (Houston) and the Kleberg Center for Molecular Markers at M. D. Anderson to develop a microRNA-based diagnostic test to predict risk of disease recurrence in lung cancer patients who have undergone curative resection.
Current treatment for lung cancer includes surgical resection, which may be followed by adjuvant therapy. While patients with high risk of recurrence may benefit from adjuvant therapy, those with low risk of recurrence may be exposed to unnecessary toxicities, according to the company. The goal of this collaboration is to develop a test that will enable physicians to distinguish between patients with high and low risk of recurrence to optimize treatment regimens.
"The potential diagnostic applications of microRNA biomarkers are broad and diverse," said Amir Avniel, president/CEO of Rosetta. "We are very pleased to be collaborating with M. D. Anderson, one of the world's leading cancer research centers, on this important project in lung cancer. We believe that the experience we have in working with microRNA biomarkers, combined with M. D. Anderson's extensive experience in lung cancer research, makes this a strong collaboration which may have a significant impact on the way lung cancer patients are diagnosed and treated."
"The use of miRNA with existing genomic and proteomic information will help us achieve the goal of personalization of the treatment," said Gordon Mills, co-director of the Kleberg Center for Molecular Markers, at M. D. Anderson.
Rosetta develops microRNA-based diagnostics and therapeutics.
• LifeScan (Milpitas, California), maker of the OneTouch Brand of blood glucose meters for people with diabetes, and ResMed (Poway, California), a manufacturer of devices for the diagnosis and treatment of sleep apnea, reported an exclusive co-marketing agreement designed to improve the lives of people with Type 2 diabetes and sleep-disordered breathing (SDB). The joint work of the two companies will focus on educational and cross-promotional efforts intended to benefit the patients and healthcare professionals served by both companies. The goal is to build awareness among healthcare professionals of the overlap of these two conditions, trigger new approaches to patient care, and ultimately improve the rate of treating patients suffering from both SDB and diabetes.
The agreement between the two companies comes on the heels of a recent announcement by the International Diabetes Federation (IDF) in which the organization issued a consensus statemen on Type 2 diabetes and obstructive sleep apnea (OSA), the most common form of SDB. Issued by an IDF working group, the new statement included an urgent call-to-action regarding the need to adopt new clinical practices with respect to monitoring, screening and treating patients who present with either condition.
While more research is needed to fully understand the correlation between diabetes and OSA, it is clear that the two conditions are often linked. "Research shows that it is likely in people with Type 2 diabetes that more than 50% suffer from some form of sleep disorder including sleep apnea," said Paul Zimmet, MD, PhD, co-chair of the IDF working group that issued the consensus statement, and director of the International Diabetes Institute in Melbourne, Australia.
In addition, both conditions are under-diagnosed and, if left untreated and uncontrolled, can lead to serious complications.
LifeScan is a Johnson & Johnson (New Brunswick, New Jersey) company and a maker of blood glucose monitoring products.
• Aureon Laboratories (Yonkers, New York) reported a collaborative research effort with Dr. Ignacio Wistuba, associate professor of pathology at the University of Texas M. D. Anderson Cancer Center (Houston). The goal of the study will be to quantitate and evaluate biomarkers that are associated with progression of disease and overall survival.
The project will apply Aureon's systems pathology platform for the analysis of tissues from about 350 non-small cell lung cancer (NSCLC) patients.
Aureon's systems pathology platform applies morphometric imaging to formalin-fixed, paraffin-embedded (FFPE) tissue specimens, enabling quantitation and integration of histological attributes and multiplexed protein biomarkers on a cell-by-cell basis. Additionally, Aureon has developed a multivariate algorithm that integrates histological, molecular and clinical features to establish a comprehensive biometric signature associated with patient outcome. This approach allows for an analysis of histological and molecular information extracted from intact tissue specimens resulting in the identification of phenotypes associated with disease course.
Aureon technology also is being used to develop Prostate Px+, a prognostic, biopsy-based test which can assist men who are newly diagnosed with prostate cancer and need more accurate information to guide medical management of the disease. Prostate Px+ was released in May 2008.
Aureon Laboratories' mission is to enable personalized patient care through predictive pathology.