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BioAssay Works Introduces New Lateral-flow and ELISA Test for Key Kidney Markers |

Human KIM Rapid Test, H-RENA Strip Kit
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Human & Rat KIM-1
biomarker assay for acute kidney damage
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New Research Assay Developed: A rapid urine test for early detection of kidney injury:
Kidney injury molecule-1 (Kim-1) has been qualified by the Food and Drug Administration and European Medicines Agency as a highly sensitive and specific urinary biomarker to monitor drug-induced kidney injury in preclinical studies and on a case-by-case basis in clinical trials. Here we report the development and evaluation of a rapid direct immunochromatographic lateral flow 15-min assay for detection of urinary Kim-1 (rat) or KIM-1 (human).
The urinary Kim-1 band intensity using the rat Kim-1 dipstick significantly correlated with levels of Kim-1 as measured by a microbead-based assay, histopathological damage, and immunohistochemical assessment of renal Kim-1 in a dose- and time-dependent manner. Kim-1 was detected following kidney injury induced in rats by cadmium, gentamicin, or bilateral renal ischemia/reperfusion. In humans, the urinary KIM-1 band intensity was significantly greater in urine from patients with acute kidney injury than in urine from healthy volunteers.
The KIM-1 dipstick also enabled temporal evaluation of kidney injury and recovery in two patients who developed postoperative acute kidney injury following cytoreductive surgery for malignant mesothelioma with intraoperative local cisplatin administration. We hope that future, more extensive studies will confirm the utility of these results, which show that the Kim-1/KIM-1 dipsticks can provide a sensitive and accurate detection of Kim-1/KIM-1, thereby providing a rapid diagnostic assay for kidney damage and facilitating the rapid and early detection of kidney injury in preclinical and clinical studies. ...
RenaStick was developed at Bioassay Works using epitopically distinct antibodies raised in our laboratory ... An extensive characterized and evaluation of RenaStick was then performed in our laboratory. ...
Excerpted text above is ©2009 International Society of Nephrology, February
http://www.kidney-international.org
Kidney International advance online publication, 22 April 2009; doi:10.1038/ki.2009.96
KEYWORDS: biomarkers; cadmium; dipstick; ischemia/reperfusion injury; kidney toxicity; Kim-1
Vishal S. Vaidya, Glen M. Ford, Sushrut S. Waikar, Yizhuo Wang, Matthew B. Clement, Victoria Ramirez, Warren E. Glaab, Sean P. Troth, Frank D. Sistare, Walter C. Prozialeck, Joshua R. Edwards, Norma A. Bobadilla, Stephen C. Mefferd and Joseph V. Bonventre
Correspondence: Vishal S. Vaidya, Renal Division, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Harvard Institutes of Medicine, Room no. 568, 4 Blackfan Circle, Boston, Massachusetts 02115, USA. E-mail: vvaidya@partners.org
Complete article is available for subscribers at http://www.nature.com/ki/journal/v76/n1/full/ki200996a.html
Sales Contact for RenaStick: Stephen Mefferd, V.P. Business Development
Email: smefferd@bioassayworks.com |
BioAssay Works Awarded $50k TEDCO Grant
to Develop Rapid Smallpox Diagnostic
June 26, 2009 - BioAssay Works, LLC has been awarded a $50 thousand grant by Maryland Technology Development Corporation (TEDCO) under its Fort Detrick Technology Transfer Initiative (FDTTI). The grant is for development of an optimized, highly sensitive, rapid, visual diagnostic test able to detect and differentiate among multiple pathogenic poxviruses, including smallpox. If the initial proof-of-concept is successful, other diagnostic capabilities will be added to allow differential diagnosis of other illnesses that present acute vesiclar and pustular rash symptoms similar to smallpox. Current diagnostic protocols for smallpox are subjective, slow, and cumbersome. The objective is the delivery of a rapid, lateral-flow assay that will provide government agencies and first responders a vital tool for rapid, point-of-care identification of high priority bio-threats.
Resources for the grant, the maximum amount available under the FDTTI, come from a federally funded program. Work will be conducted under a three-way Cooperative Research and Development Agreement with BioFactura, Inc. of Rockville, Maryland, and the laboratories of Dr. Jay Hooper at the US Army Medical Research Institute of Infectious Diseases (USAMRIID) at Ft. Dietrick. Dr. Hooper’s laboratory will provide materials for generation of monoclonal antibodies and viral proteins, as well as samples for testing. BioFactura will produce recombinant antibodies and antigens to be used by BioAssay Works in designing, producing, and validating the test.
This grant from TEDCO allows us to focus our skills and proprietary rapid-assay development technology on a project of great importance both to the military and the civilian population. We look forward to collaborating with USAMRIID and BioFactura to make this a success. This product will help address the critical need for rapid identification of smallpox infection in the event of a bioterror attack. - Robert Greenfield, BioAssay Works CEO
About BioAssay Works, LLC
BioAssay Works (Ijamsville, Maryland) develops lateral-flow, point-of-care and point-of-use diagnostic tests, with emphasis on assays requiring high sensitivity. The company has patented enabling technologies, including a lateral-flow platform, and proprietary gold-sol manufacturing methods which contribute to increased test sensitivity and specificity, and which reduce response time. BAW’s founders have extensive experience in developing FDA-approved, CE mark, and USDA-regulated ELISA and rapid tests.
About BioFactura, Inc.
BioFactura (Rockville, MD) is a pioneer in developing next generation therapeutics and diagnostics in the infectious disease arena. The Company integrates discovery and biomanufacturing technologies to accelerate critical products to market. BioFactura’s lead initiative is a Smallpox Biodefense Therapeutic Program developed in collaboration with the US Army.
About USAMRIID
USAMRIID is the lead medical research laboratory for the U.S. DOD Biological Defense Research Program, and plays a key role in national defense and in infectious disease research. The Institute conducts basic and applied research on biological threats, resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. While USAMRIID’s primary mission is focused on the military, its research often has applications that benefit society as a whole. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command. For more information, visit www.usamriid.army.mil
The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.
Corporate Contact: Robert Greenfield, CEO, email: rgreenfield@bioassayworks.com
Sales Contact: Stephen Mefferd, V.P. Business Development, email: smefferd@bioassayworks.com

News: BioAssay Works' personnel presented at the AACC Annual Meeting during the OEM lecture series.
Presentation date: Wednesday, July 28th, 2010
Lecture: BioAssay Works' Novel Colloidal Gold Nanoparticle Technology
Presentation location: Anaheim Convention Center
AACC 2010 Annual Meeting and Clinical Lab Exposition
Anaheim, CA
http://www.aacc.org
BioAssay Works is a registered trademark of BioAssay Works, LLC. The BioAssay Works logo is also a registered trademark. All text, graphics, product names, and interactive media on this website are protected by copyright and may not be copied in any medium without the express written permission of the founders of BioAssay Works, LLC. |