FDA approves Epigenomics’ Epi proColon test
http://www.biocentury.com/dailynews/company/2016-04-13/fda-approves-epigenomics-epi-procolon-test
Published on Wednesday, April 13, 2016
Epigenomics AG (Xetra:ECX) said FDA approved a PMA for its Epi proColon blood-based colorectal cancer (CRC) screening test. Epigenomics and Polymedco Inc. (Cortlandt Manor, N.Y.) will jointly market Epi proColon in the U.S.
Epigenomics spokesperson Peter Vogt said the partners expect to launch the test in the next few weeks, but did not disclose the list price.
You can also buy Kamagra from whichever part of globe you are and levitra generic online get your order Kamagra in due course of time. Every viagra pfizer canada lock has its age and it can become dysfunctional as soon as it completes its age. Dianabol quickly and effectively increases muscle mass, but there is a distinct cialis 20mg tablets phenomenon of rolling back the results, moderate toxicity and conversion to estrogens. It is a medicine used to give buy cialis sexual desire to men who suffers from erectile dysfunction. He said the company and Polymedco are discussing reimbursement with private payers and CMS, and said Epi proColon was awarded a Tier 1 reimbursement code by the American Medical Association (AMA) Current Procedural Terminology (CPT) Panel.
In November, Epigenomics appealed FDA’s request for additional data demonstrating that Epi proColon would increase compliance in patients with a history of non-compliance to recommended CRC screening programs. The request came in a response letter for Epigenomics’ PMA, the second it had received for Epi proColon.
Epi proColon detects methylated DNA of the septin 9 (SEPT9) gene in blood plasma by real-time PCR.
Epigenomics gained EUR 1.31 (25%) to EUR 6.58 on Wednesday.
Exact Sciences Corp. (NASDAQ:EXAS), which markets CRC screening test Cologuard, rose $0.34 to $7.46 on Wednesday. Cologuard is a non-invasive stool DNA test that uses a multiplexed quantitative Invader assay for the simultaneous detection of methylated and unmethylated sequences in the promoter region of the vimentin (VIM) gene.
