eageleye
4 años hace
U.S. Centers for Medicare & Medicaid Services (CMS) will not make a final decision until after 60 days. Epigenomics is now in the 30-day public comment period. The drop this morning seems a little premature given the positive public response so far.
"Berlin, October 16, 2020- Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that the U.S. Centers for Medicare & Medicaid Services (CMS) have issued a negative reimbursement proposal in connection with the National Coverage Determination (NCD) of Epi proColon, Epigenomics’ blood test for colorectal cancer screening.
The proposed NCD is preliminary. According to the statutes, a 30-day public comment period will now begin, which will be used to further convince CMS of the benefits of Epi proColon in the fight against colorectal cancer. The public response during the initial public comment period at the beginning of the NCD was overwhelmingly positive. Following the comment period, CMS will publish their final decision within 60 days. If the final decision is also negative, the Company will take the opportunity to appeal the decision."
jupp
11 años hace
Epigenomics – Conference Call on August 7, 2013
Operator
Good afternoon ladies and gentlemen, I would like to welcome you to the epigenomics half-year, 2013,
financial results and operational update conference call. At this time, all participants have been placed
on a listen-only mode. The floor will be open for questions following the presentation. I would now like
to turn the call over to Thomas Taapken, CEO and CFO at Epigenomics. You may begin your conference
call.
www.epigenomics.com/fileadmin/site_files/00_NEWS/20_investor_relations/20_finance_information/2013/Transcript_Conference_Call_August_7__2013.pdf
jupp
11 años hace
Don`t know what's going wrong.
I bought some in Germany`FRA
Yesterday`s news:
Epigenomics AG Announces H1 2013 and Q2 2013 Financial Results and Reports on Operational Highlights
07.08.2013
Berlin, Germany, and U.S.A. - Epigenomics AG (Frankfurt Prime Standard: ECX, OTC: EPGNY), the German-American cancer molecular diagnostics company, today announced its financial results for the first half and second quarter of 2013 ending June 30.
Revenue in Q2 2013 increased by 120% to EUR 343 thousand compared to Q2 2012
Operating costs decreased by 44% to EUR 2,098 thousand over Q2 2012
EBIT in Q2 improved by 53% to EUR -1,607 thousand compared to Q2 2012
Net cash flow in H1 2013 positive due to successful capital increase in January
Level 1 ADR program established
www.epigenomics.com/en/news-investors/news-media/press-releases/latest-news/article/epigenomics-ag-gibt-finanzergebnisse-des-ersten-halbjahres-und-zweiten-quartals-2013-bekannt-und-ber.html
jupp
jupp
11 años hace
Epigenomics: US study suggests blood-based Septin9 CRC screening could save lives and be health-economically beneficial
22.07.2013
CRC screening with blood-based Septin9 tests has potential to improve screening uptake and adherence rates
Septin9 testing could decrease colorectal cancer (CRC) incidence by 41% and CRC mortality by 61% at optimal screening uptake rates
Septin9 based screening shown to be cost-effective over no screening
Berlin, Germany, and U.S.A., July 22, 2013 - Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, today announced findings from a health economic study by Prof. Uri Ladabaum, M.D., M.S., et al. from the Division of Gastroenterology and Hepatology, Stanford University School of Medicine, USA.
According to the study, Septin9 testing provides potential for saving lives while being health economically beneficial as an attractive screening alternative to established methods for a population that would otherwise be non-compliant to colorectal cancer screening.
The study, which was published in “Cancer Epidemiology, Biomarkers & Prevention”, concluded that Septin9 tests would decrease CRC incidence by 41% and CRC mortality by 61% assuming optimal uptake. In addition, Septin9 tests have the potential to demonstrate significant economic benefits at acceptable costs by increasing screening rates and improving adherence over time compared to other strategies. At 75% adherence with the blood-based Septin9 test, compared to under 20% with stool-based tests (FIT) per screening cycle, Septin9 based CRC screening would be cost-effective. In the comparison, current FIT tests would be more effective and less costly than all other alternatives, assuming optimal uptake, adherence and follow-up, but this has not yet been achieved in practice.
“Colorectal cancer is the third most common cancer globally and the second most common cancer in industrialized countries. As observed in other cancer indications, screening and early detection of cancers could decrease mortality significantly. Although established screening strategies are very effective and cost efficient, compliance rates are devastatingly low due to the partly invasive and/or uncomfortable nature of the established screening methods. At least one of three eligible US citizens does not undergo CRC screening, resulting in more than 60% of CRC cases being detected in late, symptomatic stages,” explained Dr. Thomas Taapken, CEO/CFO of Epigenomics AG. “CRC screening with a convenient blood test has the potential to significantly improve screening uptake and adherence and ultimately reduce CRC incidence and mortality, as well as resulting healthcare cost.”
The basis for comparison between different screening methods in the Ladabaum study were the published results of the PRESEPT study, run with a prototype version of the Septin9 assay, and historical FIT data. There were no direct comparison data between the two methods at the time. Epigenomics recently conducted a head-to-head comparison study between its Epi proColon® test, currently under PMA review by the FDA, and FIT demonstrating non-inferiority of Epi proColon® to FIT with respect to sensitivity. The achieved sensitivity for Epi proColon was 73%, compared to 68% for FIT.
- Ends –
Contact Epigenomics AG
jupp
11 años hace
Epigenomics Establishes American Depositary Receipt (ADR) Program
09.07.2013
Epigenomics ADRs can be traded on US over-the-counter (OTC) market effective as of July 9, 2013
ADR ticker symbol EPGNY
1 ADR represents 5 ordinary company shares
Berlin, Germany, and U.S.A. - Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, today announced that the Company has established a Level 1 ADR program in the U.S.A. BNY Mellon has been appointed as the depositary bank for the ADR program. ADRs of Epigenomics are US dollar negotiable certificates representing ordinary shares of the Company at a ratio of five ordinary shares to one Epigenomics ADR. Epigenomics ADRs can be traded on the US OTC market effective as of July 9, 2013 under the ticker symbol EPGNY. Ordinary Epigenomics shares are traded in Frankfurt Prime Standard, Germany, under the ticker symbol ECX.
jupp
11 años hace
Epigenomics receives notification of priority review status and acceptance for filing by FDA of PMA application for Epi proColon®
21.02.2013
Berlin, Germany, and Seattle, WA, U.S.A. - Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, announced today that the United States Food & Drug Administration (FDA) accepted its Premarket Approval (PMA) application for Epi proColon®. The agency concluded that all information needed for the substantive review is included and has granted priority review status to the application. Epi proColon® is Epigenomics’ blood-based test for the detection of colorectal cancer (CRC).
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willlbone
4 años hace
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