Rapid sample-to-answer diagnosis of kaposi's sarcoma across sub-saharan africa using KS-complete

Active Cooperative Agreement Awarded Last action

Award ID
U01CA269199
Recipient
Awarding agency
Obligated
$4,298,478

Award facts

Assistance listing
93.395 Cancer Treatment Research
Completion date 88% complete
Place of performance
New York, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
In this proposal, we will develop, manufacture, and perform a multi-site sub-saharan african clinical validation of KS-complete - the first true point-of-care sample-to-answer diagnostic system for kaposi's sarcoma (KS). Our recent large-scale studies in africa have shown that KS can be diagnosed through quantification of kaposi's sarcoma herpesvirus (kshv) DNA in a skin biopsy with high sensitivity and specificity. These efforts have also resulted in the development of tiny - a robust, easy-to-use, infrastructure-free, point- of-care (POC) technology for kshv DNA quantification - which is being currently deployed in a multi-site evaluation. The work has also revealed that the key challenge to widespread adoption of skin biopsy-based POC systems is the time and manual steps required to extract DNA from a skin biopsy - which can be up to 4 hours. KS-complete will be the first "direct-to-lamp" diagnostic system for skin punch biopsies. Similar direct-to-lamp methods have greatly simplified POC diagnostics for other sample matrices but the solid-phase, collagenous nature of skin has made this a challenge for biopsies. KS-complete will address this issue with our "slicer" technology that will automatically process a punch biopsy into smaller "micro-cores" on which we can directly perform DNA quantification in tiny through our "direct-to-lamp" approach. This approach will reduce the time to result to around 60 minutes, eliminate all the current manual and intensive sample processing steps, and is compatible with cost, robustness, infrastructure, and simplicity requirements for operation in lmics. Clinical validation of the system will be done through our established network of KS clinical sites in africa. By the end of the project, we will deliver 12 KS-complete systems and conduct a multi-site clinical validation. KS is one of the most common cancers in men and women in sub-saharan africa. KS is difficult to distinguish from other skin conditions, particularly in africa where access to trained pathologists is limited and immunohistochemistry is practically non-existent. Early-stage and more accurate diagnosis would confer many clinical benefits. For patients who have KS, IT obviates the need for the difficult to obtain, slow, and unreliable histopathology and allows for detection at earlier clinical stages resulting in better clinical outcomes. For patients with mimickers, rapid exclusion of KS allows for timely RE-orienting of the diagnostic process and prevents use of potentially toxic chemotherapy. Our direct-to-lamp diagnostic test could have significant impact beyond the diagnosis of KS as multiple other viral, mycobacterial and fungal-related skin diseases currently diagnosed through traditional pathology could be transitioned to this method and ultimately the point of care.

Transactions

Action Obligated Date
Amendment $147,547
Amendment $417,866
Amendment $573,896
Amendment $0
Amendment $0
Amendment $612,608
Amendment $612,608
Amendment $612,608
Amendment $0
Amendment $0
Amendment $0
Amendment $6,607
Amendment $6,607
Amendment $6,607
Amendment $650,762
Original award $650,762
Show all 16

Subawards

Subrecipient Amount Awarded
The Infectious Diseases Institute LIMITED Field testing in Uganda of whether the thin slice produced by the Slicer device and the accompanying two-step D2L solubilization procedure is suitable for KS… $147,547
The Regents Of The University Of California. San Francisco UCSF will serve as coordinating center for the clinical field operations that occur in sub-Saharan Africa. This includes creation and quality assurance… $187,207
The Regents Of The University Of California. San Francisco $165,537
The Infectious Diseases Institute LIMITED In Year 1, Dr Semeere will lead the preparation of the human subjects protocol and submit it to IRB. Together with the research coordinator they will also… $21,600
The Infectious Diseases Institute LIMITED $0
The Regents Of The University Of California. San Francisco UCSF will serve as coordinating center for the clinical field operations that occur in sub-Saharan Africa. This includes creation and quality assurance… $0
The Regents Of The University Of California. San Francisco $120,342

Quick answers

Who received award U01CA269199?

U01CA269199 was awarded to Cornell University by National Cancer Institute (National Institutes of Health) on June 10, 2022.

How much is award U01CA269199 worth?

$4,298,478 has been obligated on U01CA269199.

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