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Roche submits cobas EGFR v2 test PMA to FDA as companion diagnostic test for AZD9291

Roche today announced it has submitted the cobas EGFR Mutation Test v2 for Premarket Approval (PMA) to the U.S. Food and Drug Administration, as a companion diagnostic test for AZD9291, an AstraZeneca investigational therapy for non-small cell lung cancer patients with an acquired resistant mutation.

30 Jul 2015

Cepheid, FIND unveil new portable molecular diagnostics system for patients suspected of TB, HIV and Ebola

Cepheid and FIND today unveiled the GeneXpert Omni, the world's most portable molecular diagnostics system enabling unprecedented access to accurate, fast and potentially life-saving diagnosis for patients suspected of TB, HIV and Ebola in even the most remote areas of the world.

28 Jul 2015

New study highlights burden of community-acquired pneumonia hospitalizations among U.S. adults

Viruses, not bacteria, are the most commonly detected respiratory pathogens in U.S. adults hospitalized with pneumonia, according to a New England Journal of Medicine study released today and conducted by researchers at Centers for Disease Control and Prevention and hospitals in Chicago and Nashville, including Vanderbilt University Medical Center.

15 Jul 2015

QIAGEN's therascreen EGFR RGQ PCR Kit to guide use of IRESSA for in NSCLC treatment

QIAGEN N.V. today received U.S. marketing (PMA) approval of its therascreen EGFR RGQ PCR Kit (therascreen EGFR test) as a companion diagnostic to guide the use of AstraZeneca's IRESSA (gefitinib) in the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC).

From QIAGEN Manchester Limited 14 Jul 2015

Study aims to determine utility of Trovagene's PCM technology for predicting response to cancer immunotherapy

Trovagene, Inc., a developer of cell-free molecular diagnostics, today announced the launch of a study that aims to determine utility of the Company's Precision Cancer Monitoring (PCM) technology for predicting response to treatment in advanced melanoma patients receiving one or a combination of the novel immunotherapy agents Yervoy (ipilumumab), a CTLA-4 inhibitor, and Opdivo (nivolumab), a PD-1 inhibitor.

8 Jul 2015

UVA Health System opens high-tech clinical genomics lab

The University of Virginia Health System has opened a high-tech clinical genomics lab that will personalize care for patients, help doctors determine the best treatments for cancers and other diseases, and allow UVA to offer the most cutting-edge clinical trials.

1 Jul 2015

Kalorama Information: NGS diagnostics can detect any number of genetic variants

Next generation sequencing may be able to bypass some of the downside of molecular testing and in doing so earn its place in clinical testing, according to Kalorama Information.

30 Jun 2015

7th Annual Personalized & Precision Medicine Conference to be held in Baltimore from Oct. 5 to 6, 2015

Arrowhead's 7th Annual Personalized & Precision Medicine Conference is coming to Baltimore, MD on October 5-6, 2015 as an official satellite event to the American Society for Human Genetics Annual Meeting.

30 Jun 2015

Veracyte named to Bay Area News Group's Top Workplaces list for second consecutive year

Veracyte, Inc., a molecular diagnostics company pioneering the field of molecular cytology, today announced that it has been named to the Bay Area News Group's prestigious Top Workplaces list for the second year in a row. The news group selects Top Workplace winners based solely on an annual survey of Bay Area-company employees.

29 Jun 2015

SeraCare Life Sciences inks CRADA with NCI to create positive controls for cancer assays

SeraCare Life Sciences, a leading partner to global in vitro diagnostics manufacturers, today announced that it has signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute, part of the National Institutes of Health, to create reference materials and positive controls for cancer assays.

26 Jun 2015

New multidisciplinary Centre For Research into Obesity and Related Diseases opens In Sao Paulo

Researchers, clinicians, health educators and policy makers all gathered on May 4th in Sao Paulo, Brazil, as the new Multidisciplinary Centre for Research into Obesity and Related Comorbidities (Cepid-OCRC) was opened at da Universidade Estadual de Campinas (UNICAMP).

From Bruker BioSpin - NMR, EPR and Imaging 22 Jun 2015

Hitachi High-Technologies, QIAGEN form new strategic partnership to advance molecular testing

Hitachi High-Technologies Corporation and QIAGEN N.V. have entered into a long-term strategic collaboration involving initiatives to deliver important advances in molecular testing.

From QIAGEN Manchester Limited 18 Jun 2015

Genes could help physicians make informed treatment decisions for metastatic colorectal cancer patients

Metastatic colorectal cancer patients tend to live longer when they respond to the first line of chemotherapy their doctors recommend. To better predict how patients will respond to chemotherapy drugs before they begin treatment, researchers at University of California, San Diego School of Medicine conducted a proof-of-principle study with a small group of metastatic colorectal cancer patients.

18 Jun 2015

Beckman Coulter brings new thinking to new lab challenges at EuroMedLab 2015

Beckman Coulter Diagnostics supports IFCC-EFLM EuroMedLab 2015 with a showcase of solutions to improve workflow for the diagnostics laboratory. Held from 22-24 June 2015 at the Paris Palais des Congrès France, the company demonstrates its dedication to moving the clinical diagnostic lab forward with its total laboratory solution—from automation, chemistry, immunoassay and haematology to microbiology and its new molecular diagnostics system.

From Beckman Coulter Diagnostics 18 Jun 2015

NGS mutational testing can help detect patients with Barrett's esophagus

Barrett's esophagus (BE) develops in a subset of patients with gastroesophageal reflux disease (GERD) and can increase the risk of developing cancer of the esophagus. Although periodic surveillance for cancer is recommended for BE patients, these examinations may fail to identify pre-cancerous dysplasia and early cancers.

9 Jun 2015

Clinical data of Trovagene's Precision Cancer Monitoring platform to be presented at two medical conferences

Trovagene, Inc., a developer of cell-free molecular diagnostics, announced today that clinical data featuring its Precision Cancer MonitoringSM platform will be presented at the 2015 Cancer Markers and Liquid Biopsies conference in San Diego, CA on June 11-12, and at the AACR Precision Medicine Series: Integrating Clinical Genomics and Cancer Therapy in Salt Lake City, UT on June 13-16.

8 Jun 2015

Roche announces FDA 510(k) clearance for cobas HSV 1 and 2 Test

Roche announced today that the US Food and Drug Administration has provided 510(k) clearance for the cobas HSV 1 and 2 Test for the direct detection and differentiation of HSV-1 and HSV-2 DNA in anogenital specimens from symptomatic patients. With dual target detection and automation, the cobas HSV 1 and 2 Test provides laboratories with the capability to report up to 94 results in significantly less time than traditional methods and provides a simplified workflow for sample handling in the laboratory.

4 Jun 2015

EKF Diagnostics highlighting cancer molecular diagnostics products at ASCO 2015

EKF subsidiary, Selah Genomics’ newly introduced PrecisionPath™ next generation sequencing (NGS) technology cancer test will be a key focus on Booth #19141...

From EKF Diagnostics 28 May 2015

Roche announces FDA clearance for cobas Cdiff Test to detect C. difficile in stool specimens

Roche announced today that the US Food and Drug Administration has provided 510(k) clearance for the cobas Cdiff Test to detect Clostridium difficile (C. difficile) in stool specimens.

26 May 2015

DF/BWCC introduces new website to provide information about precision cancer medicine

Precision cancer medicine - diagnosis and treatment based on the genetic abnormalities of a specific tumor - is playing an ever-larger role in cancer care. The field got a boost earlier this year when President Barack Obama proposed a $215 million federal Precision Medicine Initiative with cancer as one of its priorities.

21 May 2015