PARSIPPANY, N.J., Jan. 12, 2016 /PRNewswire/ — Interpace Diagnostics (NASDAQ: IDXG) announced today that Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH), the world’s leading health care diagnostics company, will begin offering Interpace’s new ThyraMirTM microRNA classifier test. Physicians will be able to order ThyraMir through LabCorp, in addition to Interpace’s ThyGenX® oncogene panel, which LabCorp already offers. These innovative assays provide enhanced options for the diagnosis of thyroid cancer in patients with indeterminate thyroid nodules.
Studies show that the combination of the two molecular tests provides unprecedented high sensitivity and specificity, enabling physicians to either rule in or rule out malignancy in thyroid nodules initially deemed indeterminate by standard cytology. In addition to providing more precise diagnostic information, performing the tests together will in many cases eliminate the need for patients to undergo a second fine needle biopsy to collect the specimen typically needed for further tests.
“This agreement with LabCorp expands the reach of our molecular diagnostic tests for indeterminate thyroid nodules, and is a significant step in increasing access to the unmatched benefits of [click to continue…]
LA JOLLA, Calif., Oct. 28, 2015 /PRNewswire/ — Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that it has earned a fourth milestone payment in its collaboration with Biogen (NASDAQ: BIIB) related to progress in the companies’ research collaboration to identify microRNAs as biomarkers for multiple sclerosis (“MS”). To earn the milestone, Regulus’ microMarkersSM division used its robust technology platform and bioinformatics expertise to analyze the treatment effects of a Biogen relapsing MS drug on circulating microRNA profiles previously identified by Regulus.
“Our partnership with Biogen is one example of how Regulus microMarkersSM is researching the role and potential of microRNAs as biomarkers for numerous diseases. We’re excited to have identified a promising microRNA biomarker for MS, which we believe was a critical step to understand how microRNAs may change response to drug treatment,” said Paul Grint, M.D., President and [click to continue…]
THOROLD, ON, Sept. 28, 2015 /PRNewswire/ – Norgen Biotek Corp., an innovative privately held Canadian biotechnology company focusing primarily on advancing powerful tools for nucleic acids (NA) and protein purification, today announced the launch of over 15 novel kits for the fast and simple isolation of NA from blood, plasma/serum and urine, including cell-free-circulating (cfc)RNA, cfcDNA and sequential cfcDNA and cfcRNA. Data from comparisons of these kits with similar kits on the market clearly indicates that Norgen’s kits yield significantly more diverse cfcRNA, owing to the fact that Norgen’s kits use a proprietary resin technology that has the ability to bind all RNA sequences irrespective of size or GC content. The sensitivity and speed of these novel kits make them very powerful tools for a number of applications including the sensitive detection of tumor biomarkers and viruses, microRNA detection by PCR, quantitative PCR, RT-PCR, microarrays, Next Gen Sequencing, etc.
Norgen’s blood/plasma/serum and urine kits utilize a convenient spin column format for NA purification from both fresh and frozen samples. In particular, the circulating NA kits provide a major advantage over other available kits in that they isolate significantly more diverse, inhibitor-free cfcRNA than any other technology on the market. Circulating NA present in 10 µL to 10 mL plasma inputs or 250 µL to 30 mL of urine inputs are [click to continue…]
-Regulus Earns $2.5 Million Milestone Payment from AstraZeneca-
-RG-125 (AZD4076) is Regulus’ 3rd Clinical Candidate, Achieving Key ‘Clinical Map Initiative’ Goal for 2015-
LA JOLLA, Calif., April 7, 2015 /PRNewswire/ — Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today the selection of RG-125 (AZD4076), a GalNAc-conjugated anti-miR targeting microRNA-103/107 (“miR-103/107”) for the treatment of Non Alcoholic Steatohepatitis (“NASH) in patients with type 2 diabetes/pre-diabetes, as a clinical candidate by AstraZeneca under the companies’ strategic alliance to discover, develop and commercialize microRNA therapeutics. RG-125 (AZD4076) is the first compound from the alliance to be selected for clinical development by AstraZeneca. In connection with the candidate selection, AstraZeneca will pay Regulus $2.5 million and will assume development of the program following acceptance of an Investigational New Drug application. In the near term, Regulus and AstraZeneca plan to submit key preclinical data on the RG-125 (AZD4076) program to be presented at a scientific meeting later this year and expect to initiate a Phase I study of RG-125 (AZD4076) in humans by the end of 2015.
“Regulus is very pleased that AstraZeneca has chosen to advance a microRNA therapeutic candidate from this exciting program toward the clinic. RG-125 acts as a novel insulin sensitizer which we believe may inform a differentiated development path to treat patients with complicated metabolic disorders,” said Neil W. Gibson, Ph.D., Chief Scientific Officer of Regulus. “RG-125 represents our third clinical development candidate to arise from our novel technologies in less than two years, which confirms the productivity of our platform, achieves a key goal under our ‘Clinical Map Initiative’, and underscores our leadership in the microRNA therapeutics field.”
Marcus Schindler, Head of Cardiovascular and Metabolic Diseases, Innovative Medicines and Early Development, AstraZeneca, said: “This is a tremendous achievement for our collaboration and an exciting step for AstraZeneca to be [click to continue…]
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Regulus Receives Orphan Medicinal Product Designation from the European Commission for RG-012, a microRNA Therapeutic in Development for the Treatment of Alport Syndrome
LA JOLLA, Calif., March 25, 2015 /PRNewswire/ — Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that the European Commission has granted orphan medicinal product designation for RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 (“miR-21”) for the treatment of Alport syndrome, a life-threatening genetic kidney disease with no approved therapy. In July 2014, the U.S. Food & Drug Administration granted orphan drug designation to RG-012 for the treatment of Alport syndrome.
“We are pleased to have received orphan medicinal product designation in the European Union for RG-012, a key microRNA therapeutic program under our ‘Clinical Map Initiative’,” said Paul Grint, M.D., Chief Medical Officer of Regulus. “Alport syndrome is a life threatening disease and patients have very limited treatment options because there is currently no approved therapy. We believe that RG-012 represents an opportunity to make a significant impact in the lives of patients with Alport syndrome and we look forward to advancing this program into the clinic.”
Regulus is currently enrolling patients in a natural history of disease study called ATHENA to gather information about the changes in renal function over time in patients with Alport syndrome. Data from [click to continue…]