22 DRUG DISCOVERY AND DEVELOPMENT
performance sample preparation technologies,” said Elizabeth Hutt, ceo of NuGEN. “In this collaboration with RainDance, we will provide cancer researchers with a new, powerful and cost-effective solution to generate high quality next-generation sequencing data.”
Agendia, a leader in molecular cancer
www.medicalnewstoday.com/info/ cancer-oncology/> diagnostics) has received its fifth US Food and Drug Administration (FDA) clearance for MammaPrint, the company’s widely used breast cancer (
www.medicalnewstoday.com/ articles/
37136.php) recurrence assay (Fig. 2).
Microarray scanners Te new clearance is comprised of two additional Agilent microarray scanners and two Agilent bioanalysers, expanding laboratory capacity to handle the increasing number of MammaPrint, TargetPrint and BluePrint test requests.
Te company said that the presence of FDA cleared equipment in both of its locations will further mitigate risk posed by a potential interruption to its business in the event of an equipment breakdown at either location.
MammaPrint previously received
several FDA clearances for clinical use in the US and remains the first FDA cleared in vitro diagnostic multivariate index assay (IVDMIA) on the market and the only FDA cleared breast cancer recurrence test.
“Agendia continues to lead by example in the genomic testing industry by ensuring that our products and equipment are in full compliance with the most recent FDA standards, despite the fact that such oversight is not mandatory,” said company founder and ceo Bernhard Sixt.
MammaPrint was previously defined by the FDA as a qualitative in vitro
diagnostic test service, performed only in Agendia’s Irvine labs. Te latest FDA clearance defines a new ‘intended use’ which allows for the test to be performed in a central laboratory.
Tis empowers Agendia to legally perform tests for the US market in both the Irvine and Amsterdam clinical laboratory improvement amendments (CLIA) and College of American Pathologists (CAP) accredited facilities, and also additional future central labs under Agendia control.
Everist Genomics, a prognostics company focused on developing
Fig. 2. Breast cancer recurrence assay MammaPrint has received its fifth FDA clearance
Detecting asbestos-related pulmonary cancers
102nd Annual Meeting in Florida from 2-6 April. NYU Cancer Institute researchers discussed various breakthroughs such as a novel test for early-stage asbestos-related pulmonary cancer, a promising treatment strategy for glioblastomas, genome- wide mapping of nickel-related cancer and greater understanding of melanoma and bladder cancer.
E
www.scientistlive.com
xperts from the Cancer Institute at NYU Langone Medical Centre presented new research findings at the American Association for Cancer Research
For example, malignant pleural mesothelioma
is an aggressive, asbestos-related pulmonary cancer that develops in the lining of the lungs. Researchers investigated a novel protein test to detect early-stage, asbestos-related pulmonary cancer. The new test can accurately identify proteins
secreted from cancerous tumors caused by asbestos exposure. In a blinded test researchers detected 15 of 19 cases of stage one or stage two malignant pleural
mesothelioma. The goal of the new diagnostic test is to find the cancer early enough to effectively treat it. The test, called Multiplex SOMAmer Assay by SomaLogic, uses SOMAmers, chemically modified single-stranded DNA molecules to bind specifically to target proteins and quantify biomarkers. The test successfully measures 19 protein
biomarkers for malignant pleural mesothelioma and quantifies the small amount of proteins secreted by tumour cells.
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44