Kephera Diagnostics

Business Name:
Kephera Diagnostics
Business Genre:
Business Description:

Kephera develops rapid tests for infectious diseases using novel immunochemistry in point-of-care format. They use their proprietary assay technology based on principles of particle interaction combined with a simple device, which together enable rapid detection of specific antibodies or antigens associated with the target pathogen. This applicable to a wide range of disease targets and applications. Kephera’s expertise extends from antigen discovery using microarrays and peptide libraries to assay development, clinical studies and validation. They collaborate with academic research institutions in the U.S. and internationally, along with researchers at the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) [1].

Data/Evidence of Effectiveness:
Kephera Diagnostics has launched a new study aimed at collecting blood samples from volunteers at least 18 years of age who have been confirmed positive for COVID-19, for use in development of an antibody test for the virus. Product is still in development [2].
Complimentary Products Needed to Perform Test:
All inclusive kit (Info from communication with company)
Setting of Care:
COVID-19 antibody tests available for diagnostic use through its laboratory once they are approved [2]
Current Status / Clinical Development Stage / Expected Milestones:
Product in development and studies are being conducted. Once approved, the test will be available for diagnostic use through Kephera’s laboratory [2].
Funding & Ownership :
Privately held startup [1,3]
Business Model:
The company’s mission is to promote more effective and more affordable medical treatment through faster, point-of-care diagnosis. Kephera’s goal is to accelerate the development of rapid, point-of-care tests for emerging infectious diseases to provide the critical diagnostic tools for medical and public health response in real-time, when and where they are most urgently needed. They combine technologies in molecular biology, immunology, chemistry and device engineering to develop novel diagnostics for this purpose [1].
Company uses their proprietary technology for their diagnsotic kits for infectious diseases so I assume this ELISA based antibody assay will include this proprietary approach to improve sensitivity [1].
History & Origins :
Kephera Diagnostics is a startup that aims to address the public health challenges of global infectious diseases with point of care assay technology. They collaborate with a global community of researchers to develop and translate new technologies into accessible products for clinical diagnostics and research applications. Kephera has recently been funded for development of new tests for several infectious diseases of global significance [1]. The company was founded in 2017 [3].
Date EUA Issued:
N/A. Product is in development [2].
1. 2. 3.
“Andrew Levin- Chief Executive Officer/Chief Scientific Officer, Nadya Karaseva- Senior Scientist and R&D Project Manager, Vashti Irani- Research Scientist, Infectious Diseases, Jeremy Schonhorn- Director of Product Development, Cameron Friedman- Research Assistant, David Boyle- Business Manager, Leah Carlson- Research Associate [1] “
No. Tests Per Day:
24 hour turnaround with a goal to ramp up to 10,000 samples/ week (info from communication with company)
Time to Result:
Test Sample Type:
Fingerstick blood, serum [2].
Technology Overview:
ELISA based test. It will rely on selected fragments of coronavirus proteins that are recognized and bound by IgG and IgM antibodies in patient serum. Individuals who are asymptomatic or who had symptoms but may not have been diagnosed with COVID-19 are likely to have made antibodies which persist for some time after their infection resolves, and these antibodies can be detected using a sufficiently sensitive and specific antibody test. However, the levels of antibody in COVID-19 patients appear to be low in many cases, making them more challenging to detect, which is why a highly sensitive test is needed [2]. 
Testing Type:
Quantitaitve and qualitative IgM and IgG antibody test [2]
Test Category:
Test Name:
Clinical Application & Need:
The test is intended to provide quantitative as well as qualitative results, indicating whether an individual was infected with COVID-19 and if so, the levels of their IgG and IgM antibodies. [2]
Age of Company:
2017 [3]

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