developing diagnostics for emerging and neglected infectious diseases

NOW AVAILABLE!

Lyme Antibody Test is available now at Kephera Diagnostics CLIA certified laboratory!

More details are coming soon!

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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

Santosh George

Research Scientist

Hetali Shah

Senior Research Associate

Gabrielle Farulla-Bastian

Senior Research Assistant

Drew Miller

Senior Research Assistant

Yevgeniy Studentsov

Senior Research Associate

Hunter Kellogg

Research Associate

Sarah Miller

Research Associate

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!

SENIOR SCIENTIST: INFECTIOUS DISEASE ASSAY DEVELOPMENT

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Kephera Diagnostics is a startup that aims to address the public health challenges of global infectious diseases with new point of care assay technology.  Our mission is to promote more effective and more affordable medical treatment through faster, point-of-care diagnosis.  We collaborate with a global community of researchers to develop and translate new technologies into accessible products for clinical diagnostics and research applications.  Kephera operates a licensed CLIA laboratory and has recently been funded for development of new tests for several infectious diseases of global significance. 

Kephera seeks candidates for the position of Senior Scientist, Infectious Disease Assay Development.  Responsibilities will include development and validation of immunoassays for a variety of infectious diseases, including parasitic, viral and others in both laboratory and point-of-care formats, documentation for product transfer, and participation in design and performance of clinical studies for regulatory submission.  This position will involve both hands-on laboratory work and management of a small research team and will be responsible for leading R&D work under several grants and contracts involving collaborations with external research and clinical groups, both in the U.S. and internationally.  The person will serve as subject matter expert for parasitology and pathogen biology in general, supporting the company’s work in these areas.

The successful candidate will possess a Ph.D. in biochemistry, molecular biology, microbiology, immunology, or other life science field and be well versed in the biochemistry, molecular biology, microbiology and immunology of human pathogens, preferably parasitic agents.  Experience in assay development for infectious diseases and practical experience with applications of diagnostics to clinical or public health issues would be valuable. Familiarity with molecular methods, immunoassays in various formats, conjugation techniques, protein purification and characterization, immunological techniques, parasitology, mammalian cell culture, synthetic peptide design, recombinant protein construction and expression in bacterial and mammalian systems, and microbiological methods is desirable. Strong laboratory and organizational skills, capability for independent problem-solving as well as teamwork, and excellent communication skills are essential. Experience writing and contributing to government grants and scientific publications is a bonus.

Kephera offers a casual yet dynamic start-up environment with free parking and commuter rail accessibility.  Kephera is committed to a diverse workplace.

To apply, please forward your CV with cover letter to Kephera Diagnostics, Attn: HR, 1 Grant St., Framingham, MA 01702 or e-mail hr@kephera.comwww.kephera.com

QUALITY ASSURANCE ASSOCIATE

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Kephera Diagnostics is a startup that aims to address the public health challenges of global infectious diseases with new point of care assay technology. Our mission is to promote more effective and more affordable medical treatment through faster, point-of-care diagnosis. 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.

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.

Join our team of enthusiastic scientists who aim to make a global change in the diagnosis and treatment of emerging infectious diseases!

Kephera seeks a motivated, entrepreneurial individual for the position of Quality Assurance Associate, to be responsible for QA for the company’s operations and CLIA laboratory.

The QA associate will be an integral contributor to the development and application of the quality management system, assist in internal audits, schedule QA related events, assist with regulatory affairs documentation and participate in creation and implementation of control procedures.

Responsibilities:

  • Participate in development of quality management system and document control
  • Quality assurance documentation for daily lab and company operations
  • Participation in regulatory affairs documentation
  • Assist in document writing, review, and formatting
  • Documentation management, maintenance, and archiving
  • Ensure compliance with documented policies and procedures
  • Assist with managing the training program and periodic compliance functions
  • Support internal and external audits and regulatory inspections, as required.
  • Identify gaps in systems and procedures
  • Perform other tasks as assigned.

Qualifications:

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

  • 1-3 years in quality assurance in medical devices or bio/pharma
  • Experience with regulatory affairs documentation desirable
  • Laboratory experience (preferred)
  • Working knowledge of 21 CFR 820 QSR, ISO 13485, ISO 14971, CLIA regulations (preferred)
  • Bachelor’s degree or higher
  • Self-motivated individual with a desire to expand QMS knowledge.
  • History of developing and maintaining controlled procedures.
  • Ability to work independently in an extremely fast-paced, dynamic environment
  • Must be a team player with good interpersonal skills
  • Excellent problem-solving, organization and communication skills.
  • Proficient in Microsoft Office Suite

Job Type: Full-time.  Partial remote work option.

To apply, please forward your CV with cover letter to Kephera Diagnostics, Attn: HR, 1 Grant St., Framingham, MA 01702 or e-mail hr@kephera.comwww.kephera.com

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 Phase II contract from the National Cancer Institute for a test for liver fluke, an exotic parasite linked to bile duct cancer

Kephera Diagnostics receives Phase II contract from the National Cancer Institute for a test for liver fluke, an exotic parasite linked to bile duct cancer Framingham, MA – October 20, 2021.  Kephera Diagnostics has been awarded a $1,999,961 million Phase II Small Business Innovative Research (SBIR) contract by the National Cancer Institute, an agency of…

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    Kephera Diagnostics, LLC

    1 Grant Street, Suite 300

    Framingham, MA 01702