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Rapid Point-of-Care Assay for Diagnosis of Neurocysticercosis in Seizure Patients

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AI149903-01
Agency Tracking Number: R43AI149903
Amount: $599,996.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA18-574
Timeline
Solicitation Year: 2018
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-01-10
Award End Date (Contract End Date): 2021-12-31
Small Business Information
30 RUSSELL RD
Wellesley, MA 02482-4316
United States
DUNS: 080462707
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 ANDREW LEVIN
 (617) 834-0950
 alevin@kephera.com
Business Contact
 ANDREW LEVIN
Phone: (617) 834-0950
Email: alevin@kephera.com
Research Institution
N/A
Abstract

Project Summary
Epilepsy, a disorder of the brain manifested by seizures, is the fourth most prevalent neurological disease,
affecting over 50 million people worldwide, or about 1 out of 150 individuals on average. The frequency of
epilepsy is distributed unevenly, however, with the vast majority of cases occurring in less developed regions
of the world. The explanation for this distribution is most likely that one third of all epilepsy cases are due to
Neurocysticercosis, known to be the most common parasitic infection of the nervous system.
Neurocysticercosis is caused by the presence of larval cysts of Taenia solium, the pork tapeworm, in the brain,
which can cause seizures and illness ranging from mild to fatal depending on their location, number and
viability. In contrast to idiopathic epilepsy, a complex disease which can be difficult to treat and resistant to
cure, Neurocysticercosis can be treated and in many cases cured with inexpensive and available anti-
helminthic drugs. Distinguishing whether the cause of seizures is idiopathic epilepsy or Neurocysticercosis is
thus a critical part of the diagnostic workup and essential to determine the appropriate course of treatment for
patients. The established procedures for diagnosing epilepsy comprise electroencephalography and imaging
via MRI, but these sophisiticated tools are of limited availability in the less developed world where
Neurocysticercosis is most frequent. On the other hand, Neurocysticercosis can be diagnosed with a
serological test that detects antibodies to T. solium cysts. The gold standard serological test, the Enzyme
Immunotransfer Blot (EITB) developed at CDC, is a laboratory-based test, however, that is not widely available
and requires significant training to carry out. Thus there is a critical need for a rapid, commercially available
point-of-care test for Neurocysticercosis that can be used to test patients with seizures, in order to identify
those with the parasitic infection so that they can be treated effectively. Development of such a test has been
identified as an urgent priority by the World Health Organization.
In the Phase I project, we will utilize recombinant and synthetic T. solium antigens corresponding to those used
in the EITB to develop a point-of-care serological test for Neurocysticercosis that will meet the criteria in the
World Health Organization’s Target Product Profile. These antigens have shown high sensitivity and specificity
in prior studies, and will be combined to further increase sensitivity for detection of single viable cysts, the most
challenging case. The point-of-care Neurocysticercosis test will be evaluated for sensitivity on a well-
characterized panel of sera from Neurocysticercosis patients confirmed by EITB or clinical diagnosis, and for
specificity on healthy controls and other disease state sera. Test results will be read using a field-friendly,
ultraportable, low-cost reader that will provide objective interpretation and enable wireless upload of data to
local devices or remote servers. Phase II will support complete development to commercial stage, clinical
evaluation and preparation for CE mark and FDA submission of the Neurocysticercosis point-of-care test.Project Narrative
Epilepsy is the fourth most common neurological disorder in the U.S. and affects over 50 million people
worldwide. This project addresses the critical need for a point-of-care test to diagnose Neurocysticercosis in
patients with epileptic seizures, as this parasitic infection is responsible for about one third of all epilepsy and is
the major cause of adult epilepsy worldwide. In Phase I, we propose to demonstrate the feasibility of a point-
of-care test for Neurocysticercosis based on recombinant or synthetic antigens. In Phase II we will refine this
assay into a manufactured product, carry out a validation study to support a 510(k) submission to FDA, and
prepare for scale up and commercial launch of the assay.

* Information listed above is at the time of submission. *

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