Biomarker News and Research

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A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Also called molecular marker and signature molecule.

Fujirebio Diagnostics receives FDA 510(k) clearance for Risk of Ovarian Malignancy Algorithm test

Fujirebio Diagnostics, the industry leader in oncology biomarker assays, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the company's HE4 Test in an algorithm called ROMA (HE4 EIA + ARCHITECT CA 125 II) to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery.

7 Sep 2011

Vertex VX-509 12-week Phase 2a study on RA meets two primary endpoints

Vertex Pharmaceuticals Incorporated today announced that treatment with the investigational selective oral JAK3 inhibitor VX-509 in a Phase 2a trial resulted in substantial and statistically significant improvements in multiple measurements of rheumatoid arthritis (RA) activity.

6 Sep 2011

Shiva Biomedical, CorMedix to extend CRMD001 phase III trial in chronic kidney disease

CorMedix Inc., a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of Cardiorenal disease, today announced it has amended its agreement with Shiva Biomedical, LLC.

6 Sep 2011

Lilly, QIAGEN partner to develop and commercialize companion diagnostic for JAK2 V617F

QIAGEN today announced that it has entered into a partnership with Eli Lilly and Company for the development, manufacturing and commercialization of a molecular companion diagnostic for an early stage investigational compound currently being developed by Lilly. Financial terms of the agreement were not disclosed.

From QIAGEN Manchester Limited 6 Sep 2011

Autism diagnosis by brain scan a possibility

A team of Stanford scientists have found that the brains of autistic children have a distinctive topography and could be captured using new imaging techniques. This could someday create a template for the autistic brain that could be used to diagnose kids at a very early age they claim.

5 Sep 2011

Nature journal publishes Metabolon's genome wide association study

Metabolon, Inc., the leader in metabolomics, biomarker discovery and biochemical analysis, announced the publication of "Human Metabolic Individuality in Biomedical and Pharmaceutical Research" in the journal Nature.

3 Sep 2011

Pemetrexed treatment produces better outcomes in ALK-translocated NSCLC patients

Patients with ALK-rearranged non-small cell lung cancer (NSCLC) responded significantly better to pemetrexed than patients whose cancer did not show ALK translocation, according to research published in the September issue of the Journal of Thoracic Oncology, the official publication of the International Association for the Study of Lung Cancer.

2 Sep 2011

FDA approves crizotinib for treatment of ALK-positive lung cancer

In a major triumph for personalized medicine, the FDA approved the drug crizotinib for use with the lung cancer type known as ALK-positive.

2 Sep 2011

CWRU, NeoProteomics sign licensing deal for four bioinformatics software programs

Case Western Reserve University and NeoProteomics Inc. have announced the university's licensing of four software programs designed to improve understanding of biology at a complex molecular level for improved treatment of cancers and various other diseases.

31 Aug 2011

Avantra is now Courtagen Life Sciences

Avantra Biosciences Corporation today announced that effective immediately it is changing its name to Courtagen Life Sciences, Inc. The company will continue to use the Avantra name for their proteomics portfolio, which includes the Avantra Biomarker System.

30 Aug 2011

FDA advisory committee postpones Panel review of Gen-Probe's PROGENSA PCA3 Assay

DiagnoCure, Inc., a life sciences company that develops and commercializes high‐value cancer diagnostic tests, announced today that Gen-Probe Incorporated, its commercial partner for the PCA3 test, received notice from the U.S. Food and Drug Administration (FDA) that the PROGENSA PCA3 Assay will not be reviewed by the Immunology Panel of FDA's Medical Devices Advisory Committee on October 14, 2011 as previously scheduled, but will be reviewed by the Panel at a later date.

30 Aug 2011

HTG announces availability of qDiscovery miRNA WTA Version 16

HTG Molecular Diagnostics today announced the availability of the qDiscovery miRNA Whole Transcriptome Array (WTA) Version 16, a complete solution for microRNA (miRNA) analysis on any sample type or size.

30 Aug 2011

Pfizer receives FDA approval of XALKORI for ALK-positive NSCLC

Pfizer Inc. has received FDA approval of XALKORI (crizotinib) capsules - the first and only therapy specifically for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

29 Aug 2011

SQI Diagnostics third quarter net loss increases to $2,691,000

SQI Diagnostics Inc., a life sciences company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics, today announced its financial and operational results for the third quarter ended June 30, 2011.

29 Aug 2011

Lundbeck Canada makes landmark donation of $2.7M to support depression research

Lundbeck Canada has made a landmark donation of $2.7 million to support ground-breaking research at the University Health Network to identify biomarkers that will enhance the diagnosis and treatment of patients suffering from major depression and bipolar disorder.

29 Aug 2011

Boehringer Ingelheim initiates two afatinib phase II studies in HER2-positive breast cancer

Boehringer Ingelheim today announced the initiation of two phase II studies, 1200.89 and LUX-Breast 2, evaluating afatinib in patients with metastatic breast cancer, who have an overexpression of the erbB2 (HER2) protein, so called HER2-positive patients. Afatinib is an irreversible ErbB Family Blocker, which binds to all erbB-family kinases including erbB2.

29 Aug 2011

Pfizer receives FDA approval for XALKORI capsules to treat ALK-positive NSCLC

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved XALKORI (crizotinib) capsules, the first-ever therapy targeting anaplastic lymphoma kinase (ALK), for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive as detected by an FDA-approved test.

29 Aug 2011

Researchers to develop diagnostic test for folate receptor autoantibody

Researchers at SUNY Downstate Medical Center have received a $50,000 grant from the SUNY Research Foundation Technology Accelerator Fund to develop a diagnostic test for the folate receptor autoantibody. This autoantibody is associated with neural tube defects, subfertility, cerebral folate deficiency in infants and autism spectrum disorders.

26 Aug 2011

Waters recognizes Head of TGen's Center for Proteomics for research excellence

Waters Corporation today recognized the Center for Proteomics at the Translational Genomics Research Institute (TGen) as a Waters Center of Innovation.

26 Aug 2011

Zinc may act as tumor suppressor in commonist form of pancreatic cancer

The essential element zinc has been shown in a new study to be a likely tumor suppressor in the commonist form of pancreatic cancer, University of Maryland scientists report in the current issue of the journal Cancer Biology & Therapy.

26 Aug 2011