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SeraCare optimizes ACCURUN 341 Nucleic Acid Positive controls

SeraCare Life Sciences, Inc. today announced that the Company has developed a new series of controls in its ACCURUN portfolio to monitor and validate molecular diagnostic test performance for detection of Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG). Through collaboration with instrument and reagent manufacturers, SeraCare has optimized the ACCURUN 341 Nucleic Acid Positive controls specifically for use with the three most popular assays currently on the market; the Gen-Probe APTIMA Combo 2 Assay, the Roche COBAS AMPLICOR CT/NG Test, and the Becton, Dickinson BD ProbeTec ET System.

6 Aug 2010

IRIS International closes AlliedPath acquisition

IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, announced today that it has closed the acquisition of AlliedPath, Inc., a private, early stage high complexity, CLIA-certified laboratory focused on oncology and molecular diagnostics.

2 Aug 2010

Bio-Path commences dosing in Liposomal Grb-2 Phase I cancer study

Bio-Path Holdings, Inc.,, a biotechnology company with drug development operations in Houston, Texas, announced today that the first patient has been dosed in a Phase I study of its cancer drug candidate, Liposomal Grb-2 (L-Grb-2 or BP-100-1.01), in patients with Acute Myeloid Leukemia (AML), Chronic Myelogenous Leukemia (CML), Acute Lymphoblastic Leukemia (ALL) or Myelodysplastic Syndrome (MDS).

30 Jul 2010

SurModics, EGEN continue collaboration on long-term controlled release of siRNA complexes

SurModics, Inc., a leading provider of drug delivery and surface modification technologies to the healthcare industry and EGEN, Inc., a privately held biopharmaceutical company focused on developing nucleic acid (DNA and RNAi) therapeutics for the treatment of human diseases, are pleased to announce they have executed a continuation of their feasibility collaboration focused on long-term controlled release of siRNA complexes.

28 Jul 2010

Neurodegenerative disease-causing infectious protein can erupt from healthy brain tissue: Study

In a startling new study that involved research on both sides of the Atlantic, scientists from The Scripps Research Institute in Florida and the University College London Institute of Neurology in England have shown for the first time that abnormal prions, bits of infectious protein devoid of DNA or RNA that can cause fatal neurodegenerative disease, can suddenly erupt from healthy brain tissue.

27 Jul 2010

Jinfiniti Biosciences moves from clinical studies to developing biomarkers

A new biotech company has grown out of laboratory and clinical studies at the Medical College of Georgia with the goal of improving the diagnosis and treatment of diabetes and cancer.

20 Jul 2010

Aduro BioTech announces issuance of two important patents

Aduro BioTech, a clinical-stage immunotherapy company, announced today the issuance of two important patents, the formation of a distinguished scientific advisory board, the addition of key members to its Board of Directors, and the reporting of preliminary top line long-term survival data from a Phase 1 clinical trial with 2 year follow-up.

15 Jul 2010

NIH awards $2.8M grant for development of diagnostic multiplex testing platform with BMB technology

Applied BioCode, Inc. and Maxwell Sensors Inc. announced today that they have received a $2.8M three-year grant from the Recovery Act Limited Competition: National Institutes of Health (NIH), for the development of a high throughput diagnostic multiplex testing platform using their Barcoded Magnetic Beads (BMB) technology for various high value immunodiagnostics and molecular diagnostic tests.

7 Jul 2010

Alnylam Pharmaceuticals initiates dosing in Phase I human clinical study with ALN-TTR01

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today it has initiated dosing in a Phase I human clinical study with ALN-TTR01. The study is aimed at evaluating the safety and tolerability of ALN-TTR01 in patients with transthyretin -mediated amyloidosis, and is also designed to provide preliminary data on human proof of concept based on measurements of TTR serum levels.

7 Jul 2010

Gen-Probe's APTIMA Trichomonas assay receives European CE mark

Gen-Probe Incorporated announced today that it has received a European CE mark for its APTIMA® assay for Trichomonas vaginalis, a common parasitic sexually transmitted disease.

1 Jul 2010

Alnylam receives Portuguese, Swedish, British approvals to initiate ALN-TTR01 Phase I study in ATTR

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that its applications for ALN-TTR01 have been given clearance by Portuguese, Swedish, and British regulatory authorities to begin clinical testing. The trial will begin enrolling patients shortly in a blinded, randomized, placebo-controlled, multicenter Phase I study.

29 Jun 2010

FDA grants Abbott 510(k) clearance to market molecular diagnostic test for detection of chlamydia, gonorrhea

Abbott announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market a new, sensitive molecular diagnostic test and instrument to simultaneously detect two of the nation's most prevalent sexually transmitted diseases (STDs), gonorrhea and chlamydia, including a new variant strain of chlamydia recently discovered in Sweden.

28 Jun 2010

Santaris Pharma, miRagen collaborate to develop microRNA-targeted medicines for cardiovascular disease

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies and miRagen Therapeutics, Inc., a biopharmaceutical company focused on developing innovative microRNA-based therapeutics for cardiovascular and muscle disease, announced today that they have formed a strategic alliance to develop microRNA-targeted medicines for the treatment of cardiovascular disease.

23 Jun 2010

FDA approves ARCHITECT HIV Ag/Ab Combo assay to aid in diagnosis of HIV-1/HIV-2 infection

The U.S. Food and Drug Administration today approved the first assay to detect both antigen and antibodies to Human Immunodeficiency Virus. This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults including pregnant women. It is also the first assay for use as an aid in the diagnosis of HIV-1/HIV-2 infection in children as young as two years old.

22 Jun 2010

Applied BioCode's novel BMB technology to be presented at Biodetection Technologies 2010 Conference

Applied BioCode, Inc. announced today a presentation to be given on their Barcoded Magnetic Beads technology at the Biodetection Technologies 2010 Conference in Arlington, Virginia. The presentation is titled "Multiplexed Assays Go Digital" and will be given by Dr. Winston Ho, President at Applied BioCode, on June 18, 2010.

18 Jun 2010

Gen-Probe invests $50M in Pacific Biosciences

Gen-Probe Incorporated and Pacific Biosciences announced today that Gen-Probe has made a $50 million strategic investment in Pacific Biosciences, a private sequencing company. In addition, the companies will work together to explore co-development of new integrated clinical diagnostics systems based on Pacific Biosciences' Single Molecule Real Time (SMRT™) platform and Gen-Probe's expertise in diagnostics.

18 Jun 2010

New biomarker study explores early detection of ovarian cancer

Despite many research advances, ovarian cancer remains lethal in a majority of cases, due to late diagnosis of the disease. In a new study, Dr. Joshua LaBaer of the Biodesign Institute at Arizona State University, along with Arturo Ramirez and Paul Lampe, researchers at the Fred Hutchinson Cancer Research Center in Seattle, used a novel method for identifying biomarkers-proteins in blood that can identify ovarian cancer before symptoms appear.

17 Jun 2010

Study shows NAT programs increase HIV detection yield by 23%

Community-based HIV testing programs generally use only HIV antibody testing, but nucleic acid testing can detect the presence of HIV earlier. Researchers at the University of California, San Diego School of Medicine studied more than 3,000 patients who sought HIV testing in community-based clinics in or near San Diego to examine the yield of testing with a rapid test plus NAT and to see whether patients would be willing to access their results by phone or computer.

15 Jun 2010

Texas Tech signs worldwide license agreement for metallo-beta-lactamase inhibitors with RI Scientific

Officials at Texas Tech University System's Office of Technology Commercialization announced Wednesday (June 9) the signing of an exclusive worldwide license agreement for a chemical additive called an aptamer that makes certain existing antibiotics viable against antibiotic-resistant bacteria.

10 Jun 2010

Takara Bio to distribute NuGEN's solutions in Japan, South Korea, China

NuGEN, the provider of innovative RNA and DNA sample preparation technologies that enable breakthrough genomic analysis, today announced it has signed a non-exclusive agreement with Takara Bio to distribute the full spectrum of NuGEN's next-generation sequencing, microarray and q-PCR nucleic acid amplification and sample preparation products in Japan, South Korea and China. In addition, Takara is authorized to offer services using NuGEN products in the same territory.

9 Jun 2010