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:7/10/2014)... CA (PRWEB) July 10, 2014 Robert Harman, ... Veterinary Medicine company, is proud to announce the relaunch of ... launching with a new series called “ What are Stem ... give an honest and straightforward foundation in the basics of ... educated decision on the right type of treatment when considering ...
(Date:7/10/2014)... July 10, 2014 EvoDerma ’s NOOME ... This rejuvenating device now comes with a second treatment cup ... time. , The new cup is thinner on the edges ... to target rough, thin and uneven surfaces on the face, ... for a stimulating treatment on areas such as the cheeks ...
(Date:7/10/2014)... , July 10, 2014  Franciscan ... use of capnography for respiratory monitoring outside ... of healthcare leaders in embracing state-of-the-art patient ... effectively patients are breathing and can alert ... By measuring the amount of carbon dioxide ...
(Date:7/10/2014)... , July 10, 2014  Kainos Capital, a ... brands, today announced that it has acquired the Slim-Fast ... in the business. Terms of the transaction were not ... and meal replacement business that markets ready-to-drink shakes, powders, ... North America and in the ...
Breaking Biology Technology:Robert Harman, DVM Talks About What Stem Cells are in His Latest Blog Series for Vet-Stem, Inc. 2Robert Harman, DVM Talks About What Stem Cells are in His Latest Blog Series for Vet-Stem, Inc. 3Introducing a New Bonus Treatment Cup for EvoDerma’s NOOME Anti-Aging Motion 2Franciscan St. Anthony Health-Crown Point Underscores Patient Safety Commitment Through Expanded Use of Capnography 2Kainos Capital Acquires Slim-Fast From Unilever 2
... NHS Northamptonshire,s Chief Executive, John Parkes , will ... after being offered a Visiting Professorship at The University of ... delighted to have been offered the role and I look ... there. "NHS Northamptonshire already has excellent links with ...
... NEW YORK and MUNICH, September 13, 2011 ... Unresectable Neuroendocrine Tumors in the Liver   ... that updated results from the metastatic neuroendocrine tumor (mNET) ... trial were presented at the Cardiovascular and Interventional ...
... Mich.---A new $13-million National Science Foundation center based ... materials that manipulate light in new ways. The ... nanoscale lasers, high-efficiency lighting, and quantum computers. ... C-PHOM, involves engineering and physics researchers from the ...
Cached Biology Technology:NHS Northamptonshire Chief Executive John Parkes Accepts Visiting Professorship 2Positive Phase 2 Trial Results from Neuroendocrine Tumor Cohort Presented at CIRSE 2Positive Phase 2 Trial Results from Neuroendocrine Tumor Cohort Presented at CIRSE 3Positive Phase 2 Trial Results from Neuroendocrine Tumor Cohort Presented at CIRSE 4Positive Phase 2 Trial Results from Neuroendocrine Tumor Cohort Presented at CIRSE 5$13-million NSF center to explore new ways to manipulate light at the nanoscale 2
(Date:7/11/2014)... Using spider toxins to study the proteins that let ... say they have stumbled upon a biological tactic that ... insect plagues in a safe and environmentally responsible way. ... be lethal for one species and harmless for a ... target specific pests without harming beneficial species like bees. ...
(Date:7/10/2014)... 30, 2014  Aware, Inc. (NASDAQ: AWRE ... previously announced on June 26, 2014 that its Board ... $1.75 per share, or approximately $40 million in total.  ... 2014 and a payment date of July 24, 2014.  ... had set an ex-dividend date for this special cash ...
(Date:7/10/2014)... DALLAS , July 3, 2014 ... Sensors Market by Type (Swipe And Area), Material (Optical ... Defense, Healthcare, Commercial Security and Banking & Finance), and ... 2020", published by MarketsandMarkets, the global Fingerprint Sensors Market ... at a high CAGR of 16.8% from 2014 to ...
Breaking Biology News(10 mins):Potent spider toxin 'electrocutes' German, not American, cockroaches 2Potent spider toxin 'electrocutes' German, not American, cockroaches 3NASDAQ Sets Ex-Dividend Date for Aware, Inc.'s Special Cash Dividend of $1.75 Per Share 2Fingerprint Sensors Market worth $14.35 Billion by 2020 2Fingerprint Sensors Market worth $14.35 Billion by 2020 3
... The National Science Foundation (NSF) is funding a ... 24 high-achieving science and math undergraduates for teaching careers. ... Program within the College of Arts and Sciences at ... mathematics majors to become high school math and science ...
... protein found in the virulent avian influenza virus strain called ... of double-stranded RNA formed during viral infection, which otherwise would ... College of Medicine researchers in an online report in the ... the protein NS1 combine to form tiny tubules where double-stranded ...
... have identified a potential new therapeutic target that could ... arthritis. The study, published online ahead of ... Immunity . Specifically, the study reveals that two molecular ... and that manipulating a protein called RBP-J involved in ...
Cached Biology News:NSF grant to launch undergrads from Case Western Reserve into math and science teaching 2NSF grant to launch undergrads from Case Western Reserve into math and science teaching 3Protein 'tubules' free avian flu virus from immune recognition 2New therapeutic target identified for rheumatoid arthritis 2
...
...
...
... Easy Clean spin filters allow for the ... Simply place your DNA gel slice in the ... majority of your DNA is recovered. There is ... special buffers. Spin filters can also be ...
Biology Products: