Biomarker News and Research

RSS

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.

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

GCC hormone receptor may also help fight obesity

The hormone receptor guanylyl cyclase C (GCC) has been established as a suppressor of colorectal cancer tumors, but new evidence from Thomas Jefferson University suggests it may also help fight one of the country's biggest pandemics: obesity.

26 Aug 2011

MDxHealth first half 2011 commercial revenues increase 19%

MDxHealth SA, a leading molecular diagnostics company in the field of personalized medicine, announced today its 2011 half-year results.

25 Aug 2011

AMT total net loss decreases 7% to € 8.7 million for first half year of 2011

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, today reported its results for the first half year of 2011.

25 Aug 2011

Insight into acrolein-induced acute lung injury

Metabolon, Inc., the leader in metabolomics, biomarker discovery and biochemical analysis, announces the publication of "Integrative Metabolome and Transcriptome Profiling Reveals Discordant Energetic Stress Between Mouse Strains with Differential Sensitivity to Acrolein-Induced Acute Lung Injury" in The Molecular Nutrition and Food Research Journal.

24 Aug 2011

CHL completes $18.4-million Series B financing round

Cleveland HeartLab Inc. (CHL), a leading specialty clinical laboratory and disease management company, today announced the completion of an $18.4-million Series B financing round.

23 Aug 2011

A CRADA for prostate disease research

Genomatix Software, the Uniformed Service University of the Health Sciences (USU), and the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) have entered into a Cooperative Research and Development Agreement (CRADA) to extend their collaborative endeavors in prostate disease research.

22 Aug 2011

Risk of depression in formerly depressed people

Depression is increasingly recognized as an illness that strikes repeatedly over the lifespan, creating cycles of relapse and recovery. This sobering knowledge has prompted researchers to search for markers of relapse risk in people who have recovered from depression. A new paper published in Elsevier's Biological Psychiatry suggests that when formerly depressed people experience mild states of sadness, the nature of their brains' response can predict whether or not they will become depressed again.

22 Aug 2011

Brain's reaction to sadness can predict risk of future depression

22 Aug 2011

Clinical trials to evaluate and validate infrastructure of P-medicine consortium

Retrospective and prospective clinical trials will be run to evaluate and validate the infrastructure of the P-medicine consortium, announced a poster at the recent 3rd symposium of the Worldwide Innovative Networking in Personalized Cancer Medicine, held in Paris 6-8 July, 2011.

18 Aug 2011

Inherited genetic links to prostate cancer discovered

Researchers from the U.S. and Sweden have linked five inherited genetic mutations to the development of a particularly aggressive and deadly form of prostate cancer. They suggest that these findings could someday lead to development of an easy-to-administer blood test to screen for such mutations to help physicians assess the long-term risk faced by newly diagnosed prostate cancer patients.

17 Aug 2011