developing diagnostics for emerging and neglected infectious diseases

COVID-19 ANTIBODY TESTING BY KEPHERA NOW AVAILABLE

Kephera now offers COVID-19 antibody testing through its CLIA laboratory

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About Us

Kephera Diagnostics is a startup that aims to address the public health challenges of global infectious diseases with point of care assay technology.  We 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.

Mission

Our 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.  We combine innovative technologies in molecular biology, immunology, chemistry and device engineering to develop novel diagnostics for this purpose.

Focus

Emerging infectious diseases are responsible for over one billion cases of illness every year and continue to be the leading cause of death worldwide.  Vector-borne diseases in particular, including malaria, dengue, Chagas, leishmania and others are major public health problems with over half of the world’s population at risk according to the World Health Organization.  Collectively, these diseases account for an annual global economic burden in the hundreds of billions of dollars. Fast and accurate diagnosis is the key to effective treatment for infectious diseases and to epidemiological monitoring on which intervention programs depend.  Diagnosis has traditionally relied on sophisticated laboratory tests, however, which are costly, complex, slow to develop, and not widely available. The unpredictability and speed with which many new infectious diseases emerge and spread makes the traditional approach unworkable – a recent example being the invasion of Zika virus in the western hemisphere in 2015.  Consequently, there is a critical need for the rapid development of diagnostics in accessible point-of-care formats that can timely and effectively address the global threat of emerging infectious diseases.

Team

Andrew Levin

Chief Executive Officer/Chief Scientific Officer

Nadya Karaseva

Senior Scientist, R&D Project Manager

Vashti Irani

Research Scientist, Infectious Diseases Diagnostics

Jeremy Schonhorn

Director of Product Development

Leah Carlson

Research Associate

David Boyle

Business Manager

Gabrielle Farulla-Bastian

Research Assistant

Hetali Shah

Research Associate

Bill Greathead

Business Development Manager

Santosh George

Research Scientist, Molecular Research

Careers

Kephera Diagnostics is a team of passionate scientists, working to brighten the future of diagnostics for emerging and neglected infectious diseases. Kephera seeks talented and enthusiastic team players inspired to make an impact on global public health by delivering better diagnostic information to patients at the point of care. Kephera offers a dynamic start-up environment combining flexibility, challenging work and the opportunity to participate in a new venture. Kephera is committed to a diverse workplace.

Benefits

Kephera offers a dynamic start-up environment combining flexibility, challenging work and the opportunity to participate in a new venture aimed at improving global public health. Kephera’s location in downtown Framingham offers free parking and commuter rail accessibility. Kephera is committed to a diverse workplace.

Medical Insurance

Dental Insurance

Paid time off

Holiday pay

Free Parking

Team Happy Hours

Open Positions

Join our team of passionate scientists who wants to make a global change in neglected infectious diseases diagnostics!

Research Associate

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Kephera seeks enthusiastic candidates for a Research Associate position to contribute to the development of infectious disease immunoassays. The successful candidate will contribute significantly to the research program and be involved in multiple aspects of the projects from basic research to clinical studies.

Qualifications required:·
  • Graduate degree in life science or undergraduate degree with 1-3 years of lab work experience.
  • Work experience with various laboratory techniques such as ELISA and Western Blot, chromatography, DNA/RNA isolation, gel electrophoresis, PCR and real-time qPCR.
  • Strong laboratory and organizational skills.
  • Capability for independent problem-solving as well as teamwork.
  • Familiarity with typical MS Office software.
  • Ability to communicate clearly in writing and in presentations.
  • Ability to adhere to documented protocols for all aspects of laboratory work, ensuring that all relevant information is collected.
  • Attention to details and ability to analyze data are crucial.
Responsibilities will include:
  • Performance of a variety of laboratory experiments utilizing standard protocols.
  • Participating in routine laboratory maintenance activities.
  • Efficient communication with supervisor to interpret data and design appropriate experiments.
  • Performance of data analysis and interpretation, delivering summarized results to supervisor and to R&D team through presenting results at meetings.

Quality Assurance Director (Part-Time)

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Kephera seeks an entrepreneurial individual for the part-time position of Quality Assurance Director, to be responsible for QA for the company’s operations and laboratory services. The QA Director will be responsible for overseeing the development and implementation of the quality management system.

Responsibilities:

  • Build and implement an FDA-compliant Quality Management System
  • Manage Design Control for new product development
  • Achieve and maintain ISO 13485 certification
  • Ensure Quality System compliance for FDA, ISO, and CE mark
  • Manage document control
  • Organize internal and external audits and regulatory inspections
  • Interface with internal R&D staff and with regulatory and clinical consultants
  • Batch record reviews, product disposition, deviations, CAPA, training
  • Risk analysis and mitigation
  • Support quality-based company culture and ensure compliance with regulatory requirements, policies and procedures

Qualifications:

Primary skills, experience and knowledge required include, but are not limited to the following:

  • 5+ years in quality assurance management in medical devices/diagnostics
  • Experience in in vitro diagnostics research and development preferred
  • In-depth knowledge of 21 CFR 820 QSR, ISO 13485, ISO 14971
  • Bachelor’s degree or higher in a life science field
  • Excellent verbal and written communication and presentation skills
  • Working knowledge of cGMP
  • Quality management of external vendors
  • Experience with document control, batch record reviews, changes and deviations, CAPA
  • Project management experience, meeting deliverables and timelines
  • Ability to manage and solve technical and business problems in a challenging start-up environment.

Technology

At Kephera, we are developing rapid tests for infectious diseases using novel immunochemistry in point-of-care format. Our proprietary assay technology is 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. The broadly enabling technology is 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. We work with some of the leading 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).

Product Pipeline

Diagnostic Test for Zika Virus Infection

Kephera is developing a test for Zika virus infection with support from a grant from the National Institutes of Health. Kephera’s Zika project is based on the identification of Zika-specific and Dengue-specific epitopes within the viral genome, from which an immunoassay will be developed in convenient and cost-effective ELISA format, and ultimately translated to point-of-care format.  To this end, we are working in collaboration with medical research institutes in the U.S. and Latin America to analyze the immunological reactivities of patient sera from Zika and Dengue-endemic regions, using a variety of epitope mapping techniques. Epitopes selected based on ability to differentiate viral infections will then be expressed synthetically or as recombinant antigens for assay development.

What is Zika?

Zika emerged in 2015 as a major public health threat in the western hemisphere, leading to an urgent need for diagnostic tools for clinical and epidemiological use. Although primary Zika infection is typically accompanied by mild symptoms, the virus has been linked to severe birth defects in infants born to infected mothers, and to potentially fatal neurological conditions including Guillain Barré syndrome.

How Does it Spread?

Zika is transmitted by the same Aedes mosquito species that transmit the related Dengue and Yellow Fever viruses, along with a variety of others such as Chikungunya.  As Dengue virus is endemic in much of the tropical world, background immunological reactivity to Dengue tends to confound the serological diagnosis of Zika infection.  Accurate diagnosis of Zika infection in the post-viremic or convalescent phase continues to be a significant challenge, calling for the development of tests which are truly specific for this virus.

How is it Diagnosed?

Zika infection can be detected by molecular assays, but this approach is only useful during the relatively brief viremic phase, typically several weeks or less. After this period, individuals including pregnant women at risk for complications caused by prior infection can only be identified by serologic assays. The close genetic relationship between Zika and other flaviviruses has made serological diagnosis extremely difficult, however, due to cross-reactivities between viral antigens.

Chagas Disease - Rapid Test

With support from a National Institutes of Health grant, Kephera is developing a new point-of-care test for Chagas disease.  Kephera scientists have identified and are purifying parasite components which promise to yield a highly sensitive and specific test.  Together with our academic collaborators in the U.S. and Latin America, we are evaluating the performance of the test as it is developed in our laboratory.

What is Chagas?

Chagas disease, a chronic infection with the parasite Trypanosoma cruzi, is the most prevalent parasitic disease in the western hemisphere, outranking even malaria. Because the disease can be asymptomatic for a long period of time, often years, most cases are not detected until the chronic stage. In the interim, infected individuals remain – most unknowingly – T. cruzi carriers.  Infection can cause severe gastrointestinal and cardiac disease, and cardiomyopathy leading to early death is a major cause of lost productivity. The global economic burden of Chagas disease is estimated at $7-19 billion/year.  Consequently, the World Health Organization (WHO) has identified Chagas disease as a top priority for public health intervention.

How Does it Spread?

Chagas disease is endemic to large regions of Latin America, where it is transmitted to humans by the triatomid bug.  Transmission can also occur through blood transfusion, organ transplant and congenitally. More than 70 million people live at risk, resulting in over 10 million infections.

How is it Currently Diagnosed?

Chagas disease can be diagnosed through the detection of antibodies to the parasite in a patient’s blood.  A variety of antibody tests have been developed, with varying performance. Because the sensitivity as well as the specificity of serologic tests can be compromised by cross-reactive antigens and by genetic diversity among T. cruzi strains, the current diagnostic approach relies on comparing and combining the results of multiple independent tests.  The shortcomings of the current generation of tests in sensitivity or specificity point to the need for newer, more accurate tests, which can preferably be carried out outside a laboratory.

Lyme disease - Diagnostic Test

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Kephera is developing a new test for Lyme disease, supported by a grant from the National Institute of Allergy and Infectious Diseases.  Lyme disease has become the most common vector-borne disease in the U.S., with over 300,000 cases per year estimated by epidemiologists.  It is a risk throughout large parts of the U.S., northern Europe and Asia.  Lyme disease presents a diagnostic challenge due to the overlap in symptoms with other disease conditions.  We are collaborating with public health agencies and medical centers that treat Lyme patients to develop a new test based on innovative technology that could improve the accuracy of diagnosis of Lyme disease.

What is Lyme Disease?

Lyme disease is caused by infection with the spirochetal bacterium Borrelia burgdorferior one of its close relatives, which are transmitted by deer ticks.  The bacteria initially spread through the skin, producing the characteristic bull’s eye rash in many patients, and often a flu-like illness. If untreated, the bacteria can disseminate within the body, causing neurological, arthritic, cardiac or other serious and debilitating symptoms.  If detected early, antibiotic treatment can be highly effective.  However, as the disease progresses, treatment can become more challenging.

borrelia2
Ixodes scapularis tick 2

How Does it Spread?

Lyme disease is transmitted by deer ticks, which inhabit grassy and woodland areas where deer and mice, their natural hosts, live.  Humans are accidental victims.  The pinhead-sized deer tick may not be seen or felt, and many people are unaware that they have been infected until symptoms appear.

How is it Diagnosed?

The circular bull’s eye rash is the hallmark of a Lyme disease infection in its early stages.  But the rash is not always seen, and the symptoms that appear later are more non-specific and may resemble other disease conditions.  To diagnose such cases, current practice calls for a two-step testing protocol. Patients are tested for antibodies to the Lyme spirochete by a screening test, and results confirmed by immunoblot, a second, more specific test.  This approach has been recommended since 1995.  However, it has been shown to be relatively insensitive in early stages of Lyme disease, and relies on immunoblot which is a subjective, labor-intensive method of limited availability.  Accordingly, there is a growing need for more sensitive and accessible testing methods for Lyme disease.  Kephera aims to provide a solution to this need through the new test under development.

Bullseye_Lyme_Disease_Rash

News

Kephera Diagnostics receives $417,074 grant award from the Massachusetts Life Sciences Center to accelerate development of its rapid COVID-19 Antigen Test

Kephera Diagnostics receives $417,074 grant award from the Massachusetts Life Sciences Center to accelerate development of its rapid COVID-19 Antigen Test Baker-Polito Administration and Massachusetts Life Sciences Center Announce More Than $1.5 Million to Support Development and Acceleration of Coronavirus Testing Solutions The full text of this announcement can be viewed at https://www.mass.gov/news/baker-polito-administration-and-massachusetts-life-sciences-center-announce-more-than-15 BOSTON —…

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Kephera Diagnostics’ new CLIA laboratory launches testing for COVID-19 antibodies

Kephera Diagnostics’ new CLIA laboratory launches testing for COVID-19 antibodies Framingham, MA – August 5, 2020 – Kephera Diagnostics announced today that it has been approved as a CLIA certified laboratory by the Massachusetts Dept of Public Health and the U.S. Centers for Medicare and Medicaid, and is now offering COVID-19 antibody testing in Massachusetts…

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Kephera Diagnostics awarded Phase II grant from the National Institute of Allergy and Infectious Diseases (NAID) for Zika virus test

Kephera Diagnostics awarded Phase II grant from the National Institute of Allergy and Infectious Diseases (NAID) for Zika virus test Framingham, MA – July 23, 2020. Kephera Diagnostics announced today that it has been awarded a two-year, $1,989,300 Phase II Small Business Innovation Research (SBIR) grant by the National Institute of Allergy and Infectious Diseases…

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Contact Us

    Email:

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    Kephera Diagnostics, LLC

    1 Grant Street, Suite 300

    Framingham, MA 01702