October 2011 Clinical Laboratory News: Industry Profiles

Industry Profiles

Roche Ends Deal to Distribute Response Bio’s Cardiovascular Panel

Roche Diagnostics terminated a sales and distribution deal with Response Biomedical after the firm failed to obtain Food and Drug Administration (FDA) clearance for its cardiovascular tests on its most current platform. Under the terms of the original deal closed in June 2008, Roche would distribute Response Bio’s cardiovascular point-of-care tests on the Ramp 200 platform. However, Response Bio failed to receive FDA clearance, which prompted Roche to terminate the deal. Response Bio’s NTproBNP assay did not meet the FDA’s requirements to receive a waiver under CLIA rules. 

Biocept and Clarient Partner on Circulating Tumor Cells Test

Biocept, Inc. and Clarient, Inc. have teamed up in an effort to commercialize a proprietary blood test for circulating tumor cells (CTCs) in breast cancer patients, which includes determining human epidermal growth factor receptor (HER2) status. The two companies will market and sell Biocept’s OncoCEE-BR CTC test to community hospitals, pathologists, and medical oncologists. Biocept will perform the test in its labs, and Clarient’s pathology group will interpret the results. The test features CTC enumeration andHER2 status of the detected CTCs by fluorescence in situ hybridization.

Johns Hopkins Uses $30M Donation to Create Personalized Cancer Center

The Johns Hopkins Kimmel Cancer Center received a $30 million donation from the Commonwealth Foundation for Cancer Research, which it will use to fund a new center focused on genomics and personalized cancer medicine research. Researchers at the new center will study genomic and epigenomic factors that affect leukemia and lung cancer patients’ responses to treatment and develop tests for early detection of various types of cancer. According to Johns Hopkins, the long-term goal of the new facility will be for these genetic discoveries to inform the development of individualized immunotherapies, such as cancer vaccines and pharmacogenomics-based treatment tools.

Modern Mobility Aids Buys Lumigene Technologies

Modern Mobility Aids has finalized a deal to acquire all of the common stock of Lumigene Technologies, a point-of-care diagnostics firm that develops products to diagnose infectious diseases. According to Modern Mobility, LumiGen's PosiCheck System, which is based on isothermal amplification technology for the near sample/point-of-care DNA diagnostic markets, reliably and economically automates DNA preparation and amplification for disease and pathogen detection.

LabCorp’s Esoterix and DHMRI Announce Assay Development Alliance

Laboratory Corporation of America’s division, Esoterix Clinical Trial Services, and the David H. Murdock Research Institute (DHMRI) have signed a strategic deal for assay development. As part of the agreement, assays developed at DHMRI will be transferred to LabCorp Clinical Trials laboratories worldwide to support global clinical studies. Services available to LabCorp’s clients through the DHMRI include biomarker discovery and proof-of-concept assays designed for early- and late-stage drug discovery and development. According to Esoterix, the collaboration also provides for the commercialization of companion diagnostics and other biomarker assays upon clinical validation in the future.

Siemens and Nephromics Finalize Deal to Develop Tests for Preeclampsia

Siemens Healthcare Diagnostics and Nephromics have inked a deal to develop two assays designed to help diagnosis preeclampsia, a potentially life-threatening condition that occurs during pregnancy and affects both mothers and their unborn children. The tests will be able to detect two biomarkers, soluble fms-like tyrosine-kinase-1 and placental growth factor, which studies have shown to provide early identification of patients with preeclampsia. “The development of assays designed to detect preeclampsia earlier is an evolving area of diagnostic medicine, and we are excited to enter into the agreement with Nephromics to offer these diagnostic solutions to our customers, clinicians and patients,” said Dave Hickey, CEO of the chemistry, immunoassay, automation, and diagnostics business unit at Siemens. The agreement will also help expand Siemens’ integrated diagnostic solutions to improve OB/GYN patient care.

Thermo Fisher Completes Phadia Purchase

Thermo Fisher Scientific Inc. completed its $3.5 billion acquisition of Phadia. The company will become part of Thermo Fisher’s specialty diagnostics business. The European Commission recently cleared the acquisition, which was cleared earlier by the U.S. Federal Trade Commission. “We are pleased to complete the acquisition of Phadia, which significantly enhances our presence in high-growth specialty diagnostics markets by adding leading allergy and autoimmunity diagnostic tests,” said Marc N. Casper, president and CEO of Thermo Fisher.

Alere and VitaPath Genetics Partner on Spina Bifida Assay

Alere and VitaPath Genetics have signed a deal for the development of molecular diagnostics tests that can be used to help prevent birth defects. Under the agreement, Alere will be granted worldwide marketing rights to VitaPath Genetics’ spina bifida risk assessment assay. VitaPath’s assay is a genetic test that identifies elevated risk in women of childbearing age for giving birth to a baby with spina bifida, a condition that can be prevented by the mother taking folic acid. The test is expected to launch next year. 

Pfizer and Qiagen Form Companion Dx Alliance for NSCLC

Qiagen and Pfizer have joined forces to develop a companion diagnostic for Pfizer’s investigational anticancer compound for non-small cell lung cancer (NSCLC). The test being co-developed by both firms is for Pfizer’s dacomitinib, an oral inhibitor of HER1 (EGFR), HER2, and HER4 tyrosine kinases. The test will be based on Qiagen's proprietary KRAS assay technology, which detects mutations of the KRAS gene frequently found in human cancers. The deal also includes clinical trails and submission for premarket approval in the U.S.

BD and Biodiversity Developing Assays for Transplant Patients

BD Diagnostics and Biodiversity SpA have entered into a regional partnership to develop and commercialize a portfolio of molecular diagnostic assays on the BD MAX System for immunocompromised patients. The partnership’s comprehensive menu of molecular diagnostic tests will be designed to improve monitoring of infections in transplant patients. “This collaboration combines the BD MAX System’s advanced automation and open system capabilities with Biodiversity’s broad port-folio and track record of bringing to market molecular assays for the management of transplant patients,” said Tom Polen, president of BD Diagnostics.

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