Navigation Links
Venaxis' APPY1 Test Passes Futility Analysis in Pivotal Clinical Study
Date:7/15/2013

CASTLE ROCK, Colo., July 15, 2013 /PRNewswire/ -- Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its CE Marked APPY1 Test, a rapid, multiple biomarker-based assay for identifying patients that are at low risk for appendicitis, today announced that the external Data and Safety Monitoring Board (DSMB) created as part of the Company's pivotal clinical trial for the APPY1 Test has recommended continuation of the pivotal clinical trial, based upon completion of the first of two futility analyses included in the clinical trial design.  Venaxis will host a conference call and webcast tomorrow morning, July 16, 2013, at 8:30 a.m. ET, to discuss the DSMB's recommendation and to provide a general corporate update.

The futility analysis, which consisted of an independent review of the validity, integrity, and clinical and scientific relevance of the ongoing study, was performed on the first 579 patients to complete the study.  The study will enroll a total of 2,000 evaluable patients.  The next and final futility analysis will include data from the first approximately 1,200 patients.

Steve Lundy, President and CEO of Venaxis, stated, "While the results of the study remain blinded to Venaxis, we are very pleased that the pivotal clinical trial has passed this important interim analysis step successfully.  The APPY1 Test performed very well in the previous 500-patient study, so we regard this outcome as encouraging and we look forward to the next assessment.  Enrollment in the pivotal study continues to accelerate as our recently initiated sites ramp-up their enrollment.  We expect to complete enrollment for the pivotal study by the end of 2013, and if the results are positive, file for FDA clearance in the first quarter 2014.  In the meantime, we continue to execute
'/>"/>

SOURCE Venaxis, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Venaxis Announces Pricing of Offering of Common Stock and Warrants
2. Venaxis Executes First Commercial Development Agreement and Receives Purchase Order from EMELCA Bioscience for Initial EU Launch
3. YouTube Channel on SEO Tips Surpasses 175,000 Views, Announces JM Internet Group
4. Eastern Clinical Trials Russia CRO Passes EMA Inspection
5. Legendary Author And Screenwriter Nora Ephron Passes Away At 71; Solar Cigarette Pays Tribute To Such A Rare Talent
6. Butamax Early Adopters Group surpasses capacity targets with addition of Big River; Membership represents 11 production facilities and nearly 900 million gallons of ethanol capacity
7. Free Expo-Hall Passes for ATA 2012
8. Accuray Surpasses 600 Installations Globally
9. Unisense FertiliTech to Present Large Scale Time-lapse Data Analysis to Improve IVF Treatment
10. New Approaches in Immunogenicity Assessment Using the New SQiDlite™ System: Case Study Analysis, New Life Science Webinar Hosted by Xtalks
11. Rigaku Publishes New Application Note for Analysis of ULSD Per ISO 13032
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/6/2015)... , ... July 06, 2015 , ... ... and cheaper molecular diagnostic tests are key drivers of the global molecular diagnostics ... personalized medicine and the introduction of new companion diagnostic tests will increase demand ...
(Date:7/6/2015)... a leading Regulatory Service provider, today announced that it has opened a ... Colombia . Navitas, expansion into Latin America ... , the third largest economy in Latin America ... http://photos.prnewswire.com/prnh/20150703/228239LOGO ... Navitas regulatory professionals in close to or the same time zone and ...
(Date:7/3/2015)... ... July 03, 2015 , ... ... applications such as animal waste reduction, bioremediation, wastewater treatment, aquaculture and grease, ... announced today that it will be showcasing, ManureMagic™, its industry-leading product for ...
(Date:7/3/2015)... ... ... The global failure analysis market is expected to reach $7,147.0 million by ... expected to grow at the highest CAGR of 8.46%; its growth is expected to ... and academic institutions for root cause analysis of failure. The market based on the ...
Breaking Biology Technology:Demand for Personalized Medicine, Innovative Molecular Diagnostic Tests Spurring Big Growth, According to BCC Research 2Demand for Personalized Medicine, Innovative Molecular Diagnostic Tests Spurring Big Growth, According to BCC Research 3Navitas Launches Latin American Regulatory Operations Hub in Bogota, Colombia 2Navitas Launches Latin American Regulatory Operations Hub in Bogota, Colombia 3DryLet to Highlight Benefits of Patented ManureMagic™ at North American Manure Expo in Chambersburg, PA July 14-15, 2015 2Failure Analysis Market to Grow at 7.52% CAGR to 2020 2Failure Analysis Market to Grow at 7.52% CAGR to 2020 3Failure Analysis Market to Grow at 7.52% CAGR to 2020 4Failure Analysis Market to Grow at 7.52% CAGR to 2020 5
... Amnis Corporation and Gene Company, Ltd.,announced today ... Company,will sell and service the Amnis ImageStream(R) system ... Hong Kong, Shanghai,Beijing and Guangzhou now have access ... extremely pleased to have begun what we expect ...
... and Company) (NYSE: BDX ), a global medical technology company,announced ... Bank of America 2008 Healthcare Conference ... Bernstein 24th Annual Strategic Decisions Conference 2008 ... A live webcast of BD,s presentations can be accessed from the ...
... May 7 /PRNewswire-FirstCall/ Varian, Inc. (NasdaqGS:,VARI) announced that ... Glover,as a new director. Glover is the seventh ... appointed for a term expiring at the annual ... is Senior Vice President, Operations and Chief Financial ...
Cached Biology Technology:Amnis and Gene Company, Ltd. Announce Agreement to Market ImageStream Technology in China 2James T. Glover Appointed to Board of Directors of Varian, Inc. 2
(Date:6/25/2015)... 2015  Imagine a tool specifically designed to help ... life. That,s exactly what USANA,s True Health Assessment ... portable health program provides a personalized approached to measuring ... your lifestyle and nutrition. At the ... night, USANA,s THA was honored with the Industry Innovation ...
(Date:6/24/2015)... , June 24, 2015  Synaptics Inc. (NASDAQ: ... interface solutions, today announced that Sharp has selected ... secure authentication for its latest flagship smartphone device, ... than 200 million shipments of its fingerprint ID ... Synaptics, strength, scalability and leadership in the biometrics ...
(Date:6/23/2015)... DUBLIN , June 22, 2015 ... has announced the addition of the "Body-Worn ... Share, Growth, Trends and Forecast 2014 - 2020" ... report offers strategic analysis of the global body-worn ... market has been segmented on the basis of ...
Breaking Biology News(10 mins):@USANAinc's Personalized Nutrition Program Wins Industry Innovation Award 2Synaptics Brings Natural ID Technology to Sharp's Newest Flagship Smartphone 2Body-Worn Temperature Sensors Market - Global Industry Analysis 2
... in behaviour among the population have accelerated the recent decline ... in Science shows how there has been an almost 50 ... researchers attribute to people delaying when they first have sex ... fell most steeply at young ages, with a drop in ...
... one of the oldest healing remedies known to medicine, ... A review article in the most recent issue of ... the data. , Scientists performed 22 trials involving 2,062 ... 16 trials that were performed on experimental animals. Honey ...
... created in this cool movie , ,Scientists ... created polymer nanotubes that are unusually long (about 1 centimeter) ... Described in a new paper in Proceedings of the National ... as channels for tiny volumes of chemicals in nanofluidic reactor ...
Cached Biology News:HIV decline in Zimbabwe linked to behavioural change 2Stable polymer nanotubes may have a biotech future 2
Umbilical cord blood mesenchymal stem cells, For immunohistochemistry (IHC) Cell Chip with Human Umbilical Cord Blood Progenitor Cells...
Human peripheral blood CD19+ B cells, For immunohistochemistry (IHC) Cell Chip with Human Peripheral Blood Monocytes, B Cells, NK Cells and Stem Cells...
Umbilical cord blood CD14+ Monocytes, For immunohistochemistry (IHC) Cell Chip with Human Umbilical Cord Blood Monocytes, B Cells and NK Cells...
Umbilical cord blood basophils, For immunohistochemistry (IHC)...
Biology Products: