Framingham, MA, April 24, 2020…….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.  The new test will determine whether symptomatic as well as asymptomatic individuals have been infected with the virus that causes COVID-19 by detecting antibodies to specific fragments of the virus. Volunteers will be provided with a kit to collect a finger prick blood sample at home, which will be returned in a prepaid mailer to the company for use in test development.  

 

The test under development is an ELISA and will rely on selected fragments of coronavirus proteins that are recognized and bound by IgG and IgM antibodies in patient serum.  Kephera scientists have identified sensitive and specific antibody targets within the virus causing COVID-19 using a combination of bioinformatics, laboratory experimentation, and experience in development of similar tests for the original SARS virus that caused an outbreak in 2003-4.  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.  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.  

 

An important, emerging question is whether individuals who have antibodies to the virus that causes COVID-19 have acquired protective immunity.  To answer this question, tests which can accurately measure the levels of IgG and IgM antibodies quantitatively in blood samples are needed.  The test that we are developing will enable such quantitation and may eventually be useful in determining whether an individual has a high enough level of antibodies to be considered immune to re-infection.  While the current study is aimed at supporting test development, Kephera expects to make the COVID-19 antibody tests available for diagnostic use through its laboratory once they are approved. 

Framingham, MA – January 13, 2020.  Kephera Diagnostics has been awarded a two-year, $600,000 Phase I SBIR grant from the National Institute of Allergy and Infectious Diseases (NIAID) to develop a point-of-care test for Neurocysticercosis, the company announced today.  Neurocysticercosis is an infection of the central nervous system with the larval form of the pork tapeworm, Taenia solium.  Humans are infected with the tapeworm through the consumption of undercooked pork.  While the presence of a tapeworm does not tend to produce serious illness in the carrier and may go unnoticed, Cysticercosis results when eggs of the tapeworm, passed from carriers into the environment, are accidentally ingested.  The eggs hatch into larvae which can travel to the central nervous system and encyst in the brain, leading to the neurological form of the disease, Neurocysticercosis.  Depending on the numbers of cysts and their locations, Neurocysticercosis may result in a spectrum of symptoms, the more serious typically manifesting as epileptic-like seizures.  If untreated, Neurocysticercosis may be incapacitating or fatal.  Fortunately, Neurocysticercosis can be effectively treated by inexpensive drugs. While less well known in the U.S., Neurocysticercosis is the most common neurological disease of infectious origin worldwide, accounting for about one third of all epilepsy cases in endemic countries.  Estimates of the number of people infected globally range from 8 to 50 million according to the World Health Organization (WHO) and other sources, with endemic regions spanning much of Asia, Africa and Latin America, and extending into Europe.  The disease has been brought to the U.S. largely through immigrants who acquired it elsewhere, with 221 deaths reported over a 13 year period.  The economic burden of Cysticercosis, estimated at 2.8 million disability-adjusted life years, underscores its ranking by WHO as one of the top causes of foodborne death and disability worldwide. The medical and economic impact of Cysticercosis has led to sustained efforts by WHO aimed at intervention and eventual eradication. Kephera’s point-of-care test is intended for use in discriminating Neurocysticercosis from other causes of seizures in patients presenting with epileptic-like symptoms.  While sophisticated laboratory tests have been available for T. solium infection, this will be the first point-of-care test.  “Neurocysticercosis is one of the more neglected parasitic disease problems” said Dr. Andrew Levin, Chief Executive Officer of Kephera Diagnostics and Principal Investigator under the contract.  “We believe that the availability of a point-of-care test that could help triage patients for appropriate diagnostic follow up and therapy will contribute to improving clinical care for millions of people who suffer from seizures worldwide”. The grant awarded by NIAID is number 1R43AI149903. About Kephera Diagnostics Kephera Diagnostics is a startup that aims to address the public health challenges of global, emerging 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 major public health significance. Contact: Andrew Levin, PhD Chief Executive Officer and Scientific Director 617-834-0950 alevin@kephera.comwww.kephera.com

The National Cancer Institute, an agency of the National Institutes of Health, has awarded a Phase I Small Business Innovative Research (SBIR) contract to Kephera Diagnostics (Framingham, MA) for $299,997 to develop a test for liver fluke infection, the company announced today.  The Phase I contract will enable the company to develop a prototype of the test and to evaluate its performance on patients who have been infected with this parasite. Successful results from this evaluation could lead to further SBIR funding for product development and clinical trials. Liver flukes are acquired by eating raw freshwater fish that are infected with the parasites. They are endemic in large parts of Asia, including China, Korea and Southeast Asia, with estimates of up to 45 million people infected. The parasites live in the bile ducts and can apparently survive for decades, with symptoms ranging from mild to severe depending on parasite burden and duration of infection. Infection can be treated effectively by relatively inexpensive and accessible drugs. However, long-term infection with liver flukes has been linked to cholangiocarcinoma, a relatively uncommon but highly lethal cancer which may occur years later. Accordingly, several liver fluke species have been designated as biological carcinogens by the World Health Organization.

Liver fluke infection has been raised as a possible risk factor for cholangiocarcinoma in U.S. personnel who served in Vietnam during the war between 1961-1975. A 2018 study found evidence of an elevated rate of exposure to the parasites in a group of Vietnam veterans, based on the detection of an immune response to parasite antigens. The test used in that study is not available in the U.S., however. 

The NCI contract will support Kephera’s efforts to develop a test for liver fluke infection which could ultimately be used to screen Vietnam veterans as well as others who may be at risk for infection based on potential exposure in endemic countries. The test, which will rely on parasite-derived immunological markers, will be developed in both laboratory-based and point-of-care formats to enable testing in a variety of settings, including endemic regions where few laboratory facilities are available. Kephera scientists are planning to work with collaborators in public health and research agencies in Vietnam, who will provide samples to aid in development of the test, which will be carried out in Kephera’s laboratory in the U.S. 

“We look forward to the challenge of developing a rapid and accurate test for liver fluke infection” said Dr. Andrew Levin, Chief Executive Officer of Kephera Diagnostics and Principal Investigator under the contract.  “There is a clear need for such a test, based on the clinical and economic impact of infection worldwide, and this project is directly in line with Kephera’s mission to address emerging and neglected infectious diseases with new and accessible diagnostics.” The contract awarded to Kephera Diagnostics is NIH Award No. 75N91019C00048.

About Kephera Diagnostics
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.

Contact:
Andrew Levin, PhD
Chief Executive Officer and Scientific Director
617-834-0950

Framingham, MA – July 16, 2019.  The National Institute of Allergy and Infectious Diseases, an agency of the National Institutes of Health (NIH), has awarded a two-year, $594,008 Small Business Innovative Research (SBIR) grant to Kephera Diagnostics to develop a test-of-cure for Chagas disease, the company announced today.  The Phase I grant will enable the company to develop a prototype of the test and to evaluate its performance on Chagas patients that have undergone treatment. Successful results from this evaluation could lead to further SBIR funding for product development and clinical trials.

Chagas disease, caused by the parasiteTrypanosoma cruzi, is primarily transmitted by an insect called the kissing bug and is endemic throughout most of Latin America.  It is the most prevalent parasitic disease in the western hemisphere, infecting 6-7 million people with over 70 million at risk.   Moreover, CDC estimates approximately 300,000 cases in the U.S., principally among individuals who acquired it in endemic countries, although some autochthonous infections have also been reported. Chagas can also be transmitted congenitally, via consumption of food contaminated by kissing bugs, and rarely by blood transfusion or organ transplantation.  Infection can lead to chronic but typically asymptomatic disease lasting decades, and is associated with a higher risk of death due to cardiac or digestive system impairment.  Treatment for Chagas disease currently relies on two drugs, benznidazole and nifurtimox, the former of which was recently approved by FDA for limited use in the U.S.

Though highly effective when used during acute infection, the drugs’ efficacy decreases in chronic stage disease, treatment can be lengthy, and adverse effects are common and occasionally serious. With current methods, confirming whether a patient has been cured or not is a challenging and protracted process. At present, no test-of-cure is commercially available.  The lack of a test-of-cure has also slowed down the development of new drugs for Chagas disease, as their efficacy can be difficult to measure in clinical studies.

“A straightforward test that would provide a timely indication of whether a patient has been cured of T. cruziinfection or not after treatment is desperately needed, both to improve clinical management of patients and to evaluate new drugs and drug regimens under development” said Dr. Colin Forsyth of DNDi (Drugs for Neglected Diseases Initiative), who is not involved in the grant.

Supported by this grant, Kephera plans to develop a test that will help determine whether treatment has successfully cured a patient’s infection. The test will rely on immune responses to T. cruziantigens selected for their ability to distinguish infected from cured individuals. The test will be translated into both laboratory-based and point-of-care formats to address the needs of clinical and field settings. Kephera scientists will develop the test in collaboration with Infynity Biomarkers (Lyon, France), Vitalant Research Institute (San Francisco, CA) and the Institute of Tropical Medicine at the University of Sao Paulo (Sao Paulo, Brazil).

“This grant adds to our existing work on Chagas diagnosis in a significant way” said Dr. Andrew Levin, Chief Executive Officer of Kephera Diagnostics and Principal Investigator under the grant.  “Developing a test-of-cure fits with Kephera Diagnostics’ mission to address the diagnostic needs and challenges posed by emerging and neglected diseases, of which Chagas has been called the most neglected of the neglected diseases”.

The grant awarded to Kephera Diagnostics is NIH Award No. 1 R43 AI147973.

Framingham, MA – April 17, 2019. Kephera Diagnostics has won a two-year, $599,658 SBIR grant from the National Institute of Allergy and Infectious Diseases, an agency of the National Institutes of Health (NIH), to develop a new test for Lyme disease, the company announced today. The Phase I grant will allow the company to prove feasibility of its testing technology, after which it could pursue further funding from NIH for product development and clinical trials.
Lyme disease, a spirochetal infection transmitted by deer ticks, has become the most prevalent vector-borne disease in the United States, with approximately 300,000 cases each year according to the U.S. Centers for Disease Control. Outside the U.S., Lyme is endemic in large parts of northern Europe and Asia. The economic cost of Lyme disease is estimated at over $1 billion per year in the U.S. alone. If untreated, Lyme disease can result in a variety of neurological, arthritic and cardiac impairments. Early diagnosis and treatment can halt progression of the disease, however. While the appearance of a bull’s eye rash is the hallmark symptom of Lyme disease, many patients do not show it. For those cases, current guidelines for diagnosing Lyme disease recommend a combination of laboratory tests. The grant to Kephera will allow the company to develop a new test which promises to improve both the accuracy and the turnaround time of Lyme testing. Kephera scientists will develop the test with collaborators at Massachusetts General Hospital and the National Institute of Allergy and Infectious Diseases, both of which carry out clinical studies and operate clinics where Lyme disease patients are diagnosed and treated.
“Lyme disease continues to pose a diagnostic challenge in the clinic,” said Dr. John Branda, Associate Director of the Clinical Microbiology Laboratory at Massachusetts General Hospital. “Considering the increasing numbers of cases and the potential severity of this infection, it’s important that we work on developing tests to improve the speed and quality of diagnosis.”
“Receiving this grant award from the National Institutes of Health is a big step forward for us in our quest to develop a better diagnostic solution for Lyme disease” said Dr. Andrew Levin, Chief Executive Officer of Kephera Diagnostics and Principal Investigator under the grant. “This is a topic of great importance to us, situated as we are in the midst of a Lyme endemic region where we are constantly reminded of the impact of this disease. We hope to make a substantial contribution to public health and healthcare for affected patients through the development of this new test for Lyme.”
The grant awarded to Kephera Diagnostics is NIH Award No. 1R43AI142903.

About Kephera Diagnostics
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.
Contact:
Andrew Levin, PhD
Chief Executive Officer and Scientific Director
617-834-0950
alevin@kephera.com

www.kephera.com

Framingham, MA – November 13, 2018.  Kephera Diagnostics has won a $150,000 Phase I SBIR contract from the U.S. Centers for Disease Control and Prevention (CDC) to develop a point-of-care test for Taeniasis, the company announced today.  The Phase I contract will support the generation of key immunological reagents with which the test will be developed.  Successful completion of the first phase will enable Kephera to apply for the second Phase of the contract which will support test development and validation.

Taeniasis is infection with the pork tapeworm Taenia solium.  T. solium is a parasite that is passed from pigs to man through consumption of undercooked pork containing cysts of the tapeworm.  While the presence of a tapeworm does not tend to produce serious illness in the carrier and may go unnoticed, T. solium is linked to a much more serious infectious disease, cysticercosis.  Cysticercosis develops when eggs of the tapeworm, passed from carriers into the environment, are accidentally ingested, usually as a consequence of poor hygiene.  The eggs hatch into larvae which can travel to the central nervous system and encyst in the brain, leading to neurological illness often manifested in seizures.  If untreated, cysticercosis may be incapacitating or fatal.  Fortunately, taeniasis and cysticercosis can be effectively treated by inexpensive drugs.

While less well known in the U.S., cysticercosis is the most common neurological disease of infectious origin worldwide, accounting for about one third of all epilepsy cases in endemic countries.  Estimates of the number of people infected globally range from 8 to 50 million according to the World Health Organization (WHO) and other sources, with endemic regions spanning much of Asia, Africa and Latin America, and extending into Europe.  The disease has been brought to the U.S. largely through immigrants who acquired it elsewhere, with 221 deaths reported over a 13 year period.  The economic burden of cysticercosis, estimated at 2.8 million disability-adjusted life years, underscores its ranking by WHO as one of the top causes of foodborne death and disability worldwide. The medical and economic impact of cysticercosis has led to sustained efforts by WHO aimed at intervention and eventual eradication.

Kephera’s planned point-of-care test is intended for use in identifying tapeworm carriers, enabling treatment to prevent further spread of the disease, and to assess the effects of public health interventions.  While sophisticated laboratory tests have been available for T. solium infection, this will be the first point-of-care test.  “Cysticercosis is one of the major but more neglected parasitic disease problems worldwide” said Dr. Andrew Levin, Chief Executive Officer of Kephera Diagnostics and Principal Investigator under the contract.  “We look forward to working with our CDC colleagues on the development of a test for Taeniasis that will hopefully contribute to containing this insidious infection”.

About Kephera Diagnostics

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.

Contact:

Andrew Levin, PhD
Chief Executive Officer and Scientific Director
617-834-0950
alevin@kephera.com

www.kephera.com

Framingham, MA – September 18, 2018.  The National Institute of Allergy and Infectious Diseases, an agency of the National Institutes of Health (NIH), has awarded a two-year, $599,316 SBIR grant to Kephera Diagnostics to develop a new test for Chagas disease, the company announced today.  Under the SBIR grant program, this Phase I grant is aimed at demonstrating feasibility of the test, following which the company will be eligible to apply for second phase funding to complete product development.

Chagas, a trypanosomal disease transmitted by an insect which is endemic throughout most of Latin America, is the most prevalent parasitic disease in the western hemisphere.   Chagas infection can lead to a range of serious complications including fatal cardiomyopathy.  The disease is estimated to account for economic losses over $7 billion/year, and has been named as a top public health priority by the World Health Organization.  Existing tests have not proven as sensitive and specific as required for an accurate diagnosis, and many of the affected populations are located far from laboratories capable of running these tests.  Supported by the grant, Kephera plans to develop a point-of-care test that will deliver a highly accurate result within 15 minutes in either a field or clinical setting, without need for a laboratory.  The test is based on parasite components that were shown previously to yield high sensitivity and specificity in more complex laboratory test formats.  Kephera scientists will develop the test with collaborators at Johns Hopkins University, who have been carrying out studies on Chagas patients in South America over many years.

“Chagas disease is a major public health problem in Latin America and is present but under-recognized elsewhere, including in the U.S.” said Dr Evan Bloch at Johns Hopkins University, who is collaborating with Kephera under the grant.  “Better diagnostic methods continue to be needed, especially point-of-care assays for field use outside the laboratory”.

“We are very pleased to receive this grant award” said Dr. Andrew Levin, Chief Executive Officer of Kephera Diagnostics and Principal Investigator under the grant.  “This funding will allow us to develop a test which could facilitate rapid diagnosis and lead to better healthcare for Chagas patients, furthering our company’s mission to improve diagnosis for emerging and neglected diseases”.

About Kephera Diagnostics

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.

Contact:

Andrew Levin, PhD
Chief Executive Officer and Scientific Director
617-834-0950
alevin@kephera.com

Framingham, MA – August 18, 2017.  Kephera diagnostics announced today that it has been awarded a two-year, $598,136 SBIR grant by the National Institute of Allergy and Infectious Diseases, an agency of the National Institutes of Health (NIH), to develop a new test for Zika virus infection.

Zika virus exploded in an epidemic in 2015-2016 that is estimated to have infected over 750,000 people, and has been linked to a range of conditions including microcephaly in newborn infants and Guillain-Barré and other serious neurological disorders.  The virus is typically transmitted by Aedes mosquitoes, which also transmit Dengue virus and a variety of other related and unrelated viruses.  To determine whether individuals including pregnant women at risk for these conditions have been exposed to Zika virus requires the detection of antibodies in a blood sample, as the period during which viral nucleic acids can be found in the blood is extremely brief.   However, distinguishing Zika from other viruses in the same flavivirus family has posed a significant diagnostic challenge due to the extensive cross-reactivity between viral antigens.  The challenge is exacerbated by the fact that much of the population at risk for Zika is already seropositive for Dengue virus based on prior exposure.

“The award of this SBIR grant is an important event for Kephera Diagnostics, and validates our approach to the diagnostic challenge posed by the Zika epidemic” said Dr. Andrew Levin, Chief Executive Officer and Principal Investigator under the grant.  “While existing tests are adequate to detect acute infections, there is still no means to accurately identify post-viremic individuals at risk for the most severe consequences of Zika infection.  We aim to change this picture through development of a test capable of distinguishing Zika from other related or relevant viruses”.

Under the grant, Kephera will carry out a systematic analysis of antigenic epitopes corresponding to Zika and Dengue virus genes in an effort to identify epitopes specific for each virus, which will then be used to develop the test.  The project will involve collaboration with researchers at Blood Systems Research Institute in San Francisco, a leading center in the field of bloodborne infectious diseases that is studying blood donors carrying Zika virus.