November 2007 Clinical Laboratory News: Industry Profiles

November 2007: Volume 33, Number 11

GE, Lilly to Co-Develop Companion IVDs for Cancer Drugs

GE Healthcare (Fairfield, Conn.) announced a 3-year collaborative research agreement with Eli Lilly and Company (Indianapolis, Ind.) to discover and develop advanced in vitro diagnostic assays that can predict who will respond to targeted cancer drugs. The goal of the partnership is to find protein and gene signatures that will predict whether a medication will effectively treat certain cancers and to pre-select patients who are good candidates for the drug. “The co-development of diagnostics and therapeutics is a major strategy of GE Healthcare’s ‘Early Health’ vision, and our collaboration with Lilly and our expansion into in vitro diagnostics is right in line with this strategy,” said Michael Montalto, head of Molecular Imaging and Diagnostics Advanced Technologies for Global Research at GE. “The combination of diagnostics and therapeutics is opening new doors in the fight against cancer and other life-threatening diseases. Through the application of molecular and cell biology to understand disease, we can provide pharmaceutical companies with more advanced tools to develop more optimal drug therapies for cancer patients.”  

Epigenomics Inks Deal with Abbott for Colorectal Cancer Test

Under a new licensing agreement, Abbott Diagnostics (Abbott Park, Ill.) and Epigenomics (Seattle, Wash.) will develop a molecular test kit for the early detection of colorectal cancer, based on Epigenomics’ proprietary DNA methylation biomarker, Septin 9. The test will be the first cancer test for Abbott’s automated m2000 analyzer. Abbott will conduct the clinical trials and expects to file for FDA approval by 2010. In a letter to shareholders, Epigenomics CEO Geert Nygaard said the test represented “a real drug-sized blockbuster opportunity with a low-risk profile.” The Abbott deal marks Epigenomics’ change from a biotech company toward a molecular diagnostic player in the field of early cancer diagnostics, said Nygaard.

Celera to Work on Companion Diagnostics
 for Merck Cancer Drugs

Celera (Rockville, Md.) announced it will collaborate with Merck (Whitehouse Station, N.J.) on research to develop biomarker and pharmacogenomic tests for cancer. Under the agreement, Celera will evaluate gene expression profiles identified by Merck in order to create diagnostics predictor tests that Merck can use in clinical trials. These tests could then form the basis for commercial companion diagnostic tests for oncology drugs. “This collaboration with Merck is a strong validation of Celera’s diagnostic expertise in targeted medicine and our development capabilities,” said Thomas White, PhD, chief scientific officer at Celera. “The potential outcomes from this collaboration could lead to the development of tests that may improve individualized therapy for the treatment of cancer.” Financial details were not disclosed.

Cepheid Licenses HPV Technology from Quantovir AB

Cepheid (Sunnyvale, Calif.) plans to use the HPV patent portfolio it licensed from Quantovir AB (Uppsala, Sweden) to develop a new type of HPV test for its GeneXpert system. The test will look for high-risk types of HPV DNA, which Quantovir said it has demonstrated can be used to predict a woman’s risk of developing cervical cancer. “The GeneXpert system is ideal for the rapid diagnosis of infectious organisms like MRSA, but it can also be used to generate actionable, treatment-determining results in other medical areas, including oncology and pharmacogenomics,” said Cepheid CEO John Bishop. “An HPV test for the GeneXpert system is expected to provide accurate PCR results in minutes rather than days in a variety of clinical settings.” The new test will be designed to measure HPV viral load, which would make it unique among current HPV DNA tests, according to Cepheid. Terms of the licensing deal were not disclosed.

bioMérieux to Develop Companion Test
for New Breast Cancer Drug

bioMérieux (Marcy-l’Étoile, France) announced it will develop a companion test for Ipsen’s (Paris, France) new STS inhibitor breast cancer drug, BN 83495, which is still in development. bioMérieux will create a companion assay to pick the patients most likely to benefit from the therapy. The test will be used both for clinical development of the drug and for use as a diagnostic test on the company’s NucliSENS EasyQ molecular diagnostics platform.

PerkinElmer Acquires ViaCell

PerkinElmer (Waltham, Mass.) announced a $300 million deal for Cambridge, Mass.-based ViaCell, which makes a device for storing umbilical cord blood called ViaCord. PerkinElmer said that ViaCell’s sales and marketing organization will allow PerkinElmer to expand its neonatal and prenatal genetic screening business. “ViaCell has built a high growth business based on innovative umbilical cord blood preservation technology, with a strong, established market presence,” said PerkinElmer CEO Gregory Summe. “This is an important investment to continue expanding our genetic screening business…with an enhanced ability to reach obstetric professionals and prospective parents throughout the United States.

Perlegen and Roche’s 454 Team on Pharmacogenomics Project

Perlegen (Mountain View, Calif.) and Roche’s subsidiary 454 Life Sciences (Branford, Conn.) announced they will work together on creating a clinical test that will predict how patients respond to thiazolidinediones, or TZDs, such as Actos and Avandia. The two companies will conduct large-scale sequencing of hundreds of human DNA samples that have been collected by Perlegen from patients with specific responses to TZDs, looking for mutations in targeted regions. Using 454’s sequencing know-how and DNA amplified with Perlegen’s proprietary sample preparation and amplification technique, the companies will each examine select portions of the genome within each sample. They’ll also work together on data analysis to figure out how significant the variations are in a patient’s response to the drug class. “We are pleased to be working with 454 in this landmark pharmacogenomic study. This study holds the promise to improve therapeutic outcomes for a vast number of patients,” said Bryan Walser, MD, Perlegen CEO. Financial terms were not disclosed.

Collaboration Targets Blueprint for Drug, Diagnostic Approvals

With the goal of speeding the availability of targeted drugs and their companion diagnostic tests to patients, Ventana Medical Systems (Tucson, Ariz.) and the Critical Path Institute (C-Path) announced they will collaborate to establish model performance standards for future FDA co-submissions of drugs and diagnostics. Starting with a $2.1 million grant from Science Foundation Arizona (SFAz, Phoenix) to C-Path, Ventana will work with the FDA and NCI to apply standards the collaboration develops to a companion diagnostic test for lung cancer.

“We applaud this important project of creating a standardized evaluation process for diagnostic tests,” said Gary Kelloff, MD, Senior Scientist at the NCI. “The results of this work will complement the project with the NCI.” The FDA and NCI recently announced a new initiative called the Cancer Biomarker Collaborative (CBC) aimed at crafting recommendations on assay validation and bioinformatics to better incorporate biomarkers into drug development and clinical trials (CLN July 2007, page 1).









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