PRESS RELEASE: Cepheid and BioGX Announce Collaboration to Develop Monkeypox PCR Test for the GeneXpert® System

Cepheid and BioGX announced a collaboration between the two companies to deliver a PCR test for Monkeypox that will run on the GeneXpert system. With a global installed base of over 40,000 GeneXpert systems in 180 countries, this test could be deployed quickly in multiple settings where actionable information is needed.

According to the Centers for Disease Control and Prevention (CDC), monkeypox is rare and does not spread easily between people without close contact. While the threat of monkeypox to the general U.S. population remains low (1), it is important for healthcare providers worldwide to have a preparedness plan. One of the key signs of infection with the virus is fever with development of a maculopapular rash, often appearing as small, raised spots. However, there are many other illnesses, such as chickenpox, measles, bacterial skin infections, syphilis, herpes, and medication-associated allergies that can present with similar symptoms. This underscores the need for a molecular test that can identify monkeypox. The World Health Organization recommends PCR as the preferred laboratory test for monkeypox, using an appropriate skin lesion sample (2).

"Our FleXible Cartridge program gives Cepheid the ability to work with external partners to develop accurate tests quickly when the need arises," said David H. Persing, M.D., Ph.D., Cepheid's EVP and Chief Scientific Officer. Beginning with Bacillus anthracis (Anthrax) and continuing with Mycobacterium tuberculosis, Influenza H1N1, Ebola virus and SARS-CoV-2 among others, Cepheid has a long history of quickly developing and delivering tests that address urgent public health issues as they emerge."

BioGX also has a successful track record of working with government agencies and diagnostic partners to quickly develop and manufacture at-scale molecular tests for detection of emerging pathogens.

"We previously collaborated on a project with the CDC to develop and manufacture a multiplex Monkeypox/Orthopoxvirus test for a GeneXpert-based study (3), and now with Cepheid we are moving to the validation stage utilizing the FleXible cartridge," said Michael Vickery, Ph.D., BioGX's EVP and Chief Scientific Officer. "Regional response teams need a PCR test that is fast and easy to implement when they suspect an outbreak due to a novel pathogen."

Product in development. Not for use in diagnostic procedures. Not reviewed by any regulatory body. Product in development is subject to change and specifications have not yet been established.

References:

1. https://www.cdc.gov/poxvirus/monkeypox/index.html

2. https://www.who.int/news-room/fact-sheets/detail/monkeypox

3. Li D., Wilkins K., McCollum A.M., Osadebe L., Kabamba J., Nquete B., Likafi T., Balilo M.P., Lushima R.S., Malekani J., et al. Evaluation of the GeneXpert for human monkeypox diagnosis. Am. J. Trop. Med. Hyg. 2017;96:405–410. doi: 10.4269/ajtmh.16-0567. - DOI  https://www.ajtmh.org/view/journals/tpmd/96/2/article-p405.xml

About Cepheid

Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated molecular diagnostic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. 

About BioGX

BioGX is a leading global provider of lyophilized real-time PCR reagents for molecular diagnostics. BioGX, Inc., headquartered in Birmingham, Alabama and Dallas, TX, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively "BioGX"), operates in a cGMP compliant environment certified to ISO 13485 medical device development and manufacturing standards. The proprietary Sample-Ready™ technology is at the core of all product offerings for Clinical, Food Safety, Pharma QC and Water Quality molecular testing. BioGX's 60+ multiplex real-time PCR products are marketed and sold worldwide through its Global Distribution Network. 

Image credit: US Centers for Disease Control.

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PRESS RELEASE: New Antibody Detection Method for Coronavirus That Does Not Require a Blood Sample

Despite significant and stunning advances in vaccine technology, the COVID-19 global pandemic is not over. A key challenge in limiting the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is identifying infected individuals. Now, investigators from Japan have developed a new antibody-based method for the rapid and reliable detection of SARS-CoV-2 that does not require a blood sample.

The ineffective identification of SARS-CoV-2-infected individuals has severely limited the global response to the COVID-19 pandemic, and the high rate of asymptomatic infections (16%–38%) has exacerbated this situation. The predominant detection method to date collects samples by swabbing the nose and throat. However, the application of this method is limited by its long detection time (4–6 hours), high cost, and requirement for specialized equipment and medical personnel, particularly in resource-limited countries.

An alternative and complementary method for the confirmation of COVID-19 infection involves the detection of SARS-CoV-2-specific antibodies. Testing strips based on gold nanoparticles are currently in widespread use for point-of-care testing in many countries. They produce sensitive and reliable results within 10–20 minutes, but they require blood samples collected via a finger prick using a lancing device. This is painful and increases the risk of infection or cross-contamination, and the used kit components present a potential biohazard risk. 

Lead author Leilei Bao from the Institute of Industrial Science, The University of Tokyo, explains: “To develop a minimally invasive detection assay that would avoid these drawbacks, we explored the idea of sampling and testing the interstitial fluid (ISF), which is located in the epidermis and dermis layers of human skin. Although the antibody levels in the ISF are approximately15%–25% of those in blood, it was still feasible that anti-SARS-CoV-2 IgM/IgG antibodies could be detected and that ISF could act as a direct substitute for blood sampling.”

After demonstrating that ISF could be suitable for antibody detection, the researchers developed an innovative approach to both sample and test the ISF. “First, we developed biodegradable porous microneedles made of polylactic acid that draws up the ISF from human skin,” explains Beomjoon Kim, senior author. “Then, we constructed a paper-based immunoassay biosensor for the detection of SARS-CoV-2-specific antibodies.” By integrating these two elements, the researchers created a compact patch capable of on-site detection of the antibodies within 3 minutes (result from in vitro tests).

This novel detection device has great potential for the rapid screening of COVID-19 and many other infectious diseases that is safe and acceptable to patients. It holds promise for use in many countries regardless of their wealth, which is a key aim for the global management of infectious disease. 

The article, “Anti SARS CoV 2 IgM/IgG antibodies detection using a patch sensor containing porous microneedles and a paper based immunoassay,” was published in Scientific Reports.

About Institute of Industrial Science, The University of Tokyo

The Institute of Industrial Science, The University of Tokyo (UTokyo-IIS) is one of the largest university-attached research institutes in Japan. Over 120 research laboratories, each headed by a faculty member, comprise UTokyo-IIS, which has more than 1,200 members (approximately 400 staff and 800 students) actively engaged in education and research. Its activities cover almost all areas of engineering. Since its foundation in 1949, UTokyo-IIS has worked to bridge the huge gaps that exist between academic disciplines and real-world applications.

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