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FDA approves Roche's new HIV viral load test

Roche announced today that a new HIV viral load test has been approved by the United States Food and Drug Administration (FDA) and will be commercially available in the US later this year.

2 Jul 2012

Evolution of Advanced IVDs Conference to take place on September 19-20, 2012

IVD Technology Magazine announces the Evolution of Advanced IVDs Conference on September 19-20, 2012 at the San Diego Convention Center.

29 Jun 2012

Afirma gene expression test can reduce unnecessary thyroid cancer surgeries

Veracyte, Inc., a molecular diagnostics company that is pioneering the emerging field of molecular cytology, today announced results from a large, prospective, multicenter study, which demonstrated the potential for the Afirma® Gene Expression Classifier, a gene expression test, to reduce the large number of unnecessary surgeries in thyroid cancer diagnosis by more than half.

25 Jun 2012

FDA approves CDC DENV-1-4 Real Time RT PCR Assay to treat dengue

The Centers for Disease Control and Prevention has developed a new diagnostic test to detect the presence of dengue virus in people with symptoms of dengue fever or dengue hemorrhagic fever. The test, called the CDC DENV-1-4 Real Time RT PCR Assay, has been authorized by the Food and Drug Administration for use in the United States and can be performed using equipment and supplies many public health laboratories already use to diagnose influenza.

21 Jun 2012

Variations in microRNA expression within breast tumors can lead to sampling bias

Certain short strands of RNA, known as microRNAs (miRNAs), have been linked to the progression and metastasis of breast cancer and may provide information about prognosis. However, studies of miRNA expression profiles often report conflicting findings. While the potential for using miRNAs in breast cancer diagnosis is promising, scientists report in a new study published online today in The Journal of Molecular Diagnostics that differences in the amount and types of miRNA within breast tumors can be misleading.

15 Jun 2012

Syapse introduces Discovery app to organize R&D data and processes

Syapse announced today the commercial launch of Discovery, its cloud-based application for making omics data actionable in clinical research and development. Discovery combines a powerful platform for aggregating and structuring biomedical data with intuitive data mining, workflow, and reporting features, enabling biopharma and diagnostics companies to leverage the increasing amount of data generated by advanced omics technologies such as next-generation sequencing.

12 Jun 2012

Biomedical engineers develop SMART detector for flu diagnosis

In April 2009, the world took notice as reports surfaced of a virus in Mexico that had mutated from pigs and was being passed from human to human. The H1N1 "swine flu," as the virus was named, circulated worldwide, killing more than 18,000 people, according to the World Health Organization. The Centers for Disease Control and Prevention in the United States said it was the first global pandemic in more than four decades.

11 Jun 2012

Strand, Trovagene enter MOU to license and validate HPV assay technology

Trovagene, Inc., a developer of trans-renal molecular diagnostics, and Strand Life Sciences Pvt Ltd., of Bangalore, India, have entered into a Memorandum of Understanding (MOU) to license and validate Trovagene's proprietary Human Papillomavirus (HPV) urine test and High Risk HPV DNA Assay for clinical diagnostic and carrier screening use in India and countries in the South Asian Association for Regional Cooperation.

8 Jun 2012

Kindstar, Insight Genetics collaborate to improve cancer care in China

Molecular diagnostics company Insight Genetics and Kindstar Globalgene Technology, Inc., China's leading diagnostics company, today announced that the companies are partnering to enhance cancer care in the People's Republic of China and surrounding regions.

1 Jun 2012

Pharmspective releases ‘Molecular Diagnostics Insights in Oncology’

Pharmspective, LLC today announced the release of its second syndicated report – Molecular Diagnostics Insights in Oncology. This new extensive survey of over 400 oncologists characterizes the emerging molecular diagnostics landscape and the role and influence of specific assays in clinical management and therapy selection.

31 May 2012

GE to provide attendees with overview of new oncology solutions at ASCO annual meeting

GE Healthcare, is working to help physicians potentially improve patient care throughout the breast cancer journey through one of the most comprehensive portfolios of technologies in the industry available today.

31 May 2012

Single test developed that detects all known strains of H5N1

The close collaboration between scientists from the Experimental Therapeutics Centre (ETC) under the Agency for Science and Technology Research (A*STAR) and clinicians from Tan Tock Seng Hospital (TTSH) has enabled the successful development of the most comprehensive and rapid H5N1 bird flu test kit available to date.

29 May 2012

NanoString commences second clinical study of PAM50-based breast cancer assay

NanoString Technologies, Inc., a privately held provider of life science tools for translational research and developer of molecular diagnostics, today announced the initiation of the second clinical validation study of its PAM50-based breast cancer assay.

From NanoString Technologies 17 May 2012

Vermillion first quarter total revenue increases to $312,000

Vermillion, Inc., a leading molecular diagnostics company, reported financial and operational results for the first quarter ended March 31, 2012.

From Quest Diagnostics 16 May 2012

Trovagene receives European patent titled, ‘Methods for Detection of Nucleic Acid Sequences in Urine’

Trovagene, Inc., a developer of trans-renal molecular diagnostics, announced it has received notice of issuance of European Patent No. 2216416 entitled "Methods for Detection of Nucleic Acid Sequences in Urine."

11 May 2012

Trovagene completes PCR assay development for detection of K-RAS mutations

Trovagene, Inc., a developer of trans-renal molecular diagnostics, announced today that the Company has successfully completed the analytical development of digital PCR assays for the detection of the most prevalent K-RAS mutations, which are, according to recent estimates, observed in more than 90% of pancreatic cancers, and in 23% of all solid tumors.

30 Apr 2012

Hologic second quarter revenues increase 7.4% to $471.2 million

Hologic, Inc., a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced its results for the second fiscal quarter ended March 24, 2012.

From Hologic, Inc. 30 Apr 2012

Hologic enters definitive agreement to acquire Gen-Probe

Hologic, Inc. and Gen-Probe Incorporated today announced that their Boards of Directors have unanimously approved a definitive agreement under which Hologic will acquire all of the outstanding shares of Gen-Probe for $82.75 per share in cash, or a total enterprise value of approximately $3.7 billion.

From Hologic, Inc. 30 Apr 2012

DSG's eCaseLink EDC chosen for Ariosa's Non-Invasive Chromosomal Examination of Trisomy study

Ariosa Diagnostics, a molecular diagnostics company focused on prenatal testing, has chosen to use DSG's eCaseLink EDC (electronic data capture) system for the NEXT (Non-Invasive Chromosomal Examination of Trisomy) study.

23 Apr 2012

Health Discovery launches MelApp for melanoma risk assessment

Health Discovery Corporation, the molecular diagnostics company that launched MelApp, the first SVM-based image analysis iPhone app for melanoma risk assessment is featured in this month's Men's Health Magazine.

21 Apr 2012