FOR THE INDIVIDUAL:

Most home COVID tests are known as “rapid” tests, which means that results are typically available in less than an hour. They vary from the less rapid “diagnostic” tests in that they detect viruses differently. The rapid tests, antigen testing, check for evidence of viral particles in your nose/mouth. In contrast, the diagnostic tests, PCR, check if there is evidence of the material that the virus uses to replicate itself. PCR is considered higher quality as it can give a positive test earlier in infection when there is less virus floating around in a person’s body. It is also more expensive and requires more specialized laboratory equipment to do. Home tests are thus attractive, although they come with caveats.

Home tests are less accurate where not all people who are truly COVID positive will test positive, and not all people who are COVID negative will test negative. If one communicates with their healthcare provider, one should be able to work around this to an extent. If you have an unexpected test result, a “confirmatory” PCR may be done. There may also be sufficient clinical evidence for your provider to recommend a quarantine regardless or suggest that it would not be needed. Talking with your provider is the best thing you can do with these tests because medical science is complicated, and it is hard to make sense of it, even for healthcare professionals.

The accuracy of home testing can also vary between brands. Naturally, all tests are designed to make the best test possible. Unfortunately, consumer technique, virus, or manufacturing/storage variation can deter this desirable perfection. Fortunately, most brands are pretty good, though this illustrates the importance of communicating with your healthcare provider to ensure that you or your family members make the best healthcare decisions possible.

FOR PUBLIC HEALTH PURPOSES

Over-the-counter testing is attractive because it improves the accessibility of healthcare information. Individuals can obtain information needed to guide their actions and support public health measures flexibly and cost-effectively. While a clear advantage, there are issues with this. One could argue that consumers may not respect test results or use them as a means to justify risky behaviour. Surely now that we are over two years into the pandemic, we all understand the profound implications of the virus on ourselves and those with whom we come into contact.

A point of contention that is unfortunately not resolved is the impact on public health tracking of the disease. Many of these at-home tests lack any result reporting methods. While this should arguably be inconsequential given that those who test positive can be assumed to reach out to their healthcare providers or employers and report their status, which should then be reported to public health, valuable data can be lost in this pipeline.

Knowing the number of individuals concerned enough about COVID to test themselves, the number of tests that are positive out of all tests, and the geographic distribution of these statistics could guide public health efforts to focus on the communities that need more attention. While the number of positive tests can be used to direct resources, there is value in a more complete picture that would require these at-home tests to inherently involve result reporting, regardless of the outcome.

Fortunately, some tests already do this where one must use a mobile app to get the result or at least an “official” result. However, some tests do not involve this. While not requiring a smartphone to get one results improves the accessibility of diagnostic care because not everyone has or can afford a smartphone, it, regardless, leads to loss of information.

COVID-19 has improved the availability of medical diagnostics for the average individual. Inexpensive or free diagnostics have become widely accessible and offer flexibility that was not present in the past. While at-home COVID-19 tests are helpful, they are imperfect, and they are best used as adjunctive tools to services offered by healthcare providers. They also have their uses on the public health level, though they come with caveats considering that not all results are reported to epidemiology offices.

When the next pandemic rolls along, as we know that it will an undefined amount of time from now, hopefully, manufacturers and public health groups will take the lessons learned from our current pandemic to produce a more effective and cohesive response.

Reference: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8196235/

The post Are At-Home COVID Tests the Answer? appeared first on Medika Life.

Date of Release: Dec. 4, 2020 

SAN FRANCISCO /PRNewswire/ — Imagine swabbing your nostrils, putting the swab in a device, and getting a read-out on your phone in 15 to 30 minutes that tells you if you are infected with the COVID-19 virus. This has been the vision for a team of scientists at Gladstone Institutes, University of California, Berkeley (UC Berkeley), and University of California, San Francisco (UCSF). And now, they report a scientific breakthrough that brings them closer to making this vision a reality.

One of the major hurdles to combating the COVID-19 pandemic and fully reopening communities across the country is the availability of mass rapid testing. Knowing who is infected would provide valuable insights about the potential spread and threat of the virus for policymakers and citizens alike.

Yet, people must often wait several days for their results, or even longer when there is a backlog in processing lab tests. And, the situation is worsened by the fact that most infected people have mild or no symptoms, yet still carry and spread the virus.

In a new study published in the scientific journal Cell, the team from Gladstone, UC Berkeley, and UCSF has outlined the technology for a CRISPR-based test for COVID-19 that uses a smartphone camera to provide accurate results in under 30 minutes.

“It has been an urgent task for the scientific community to not only increase testing, but also to provide new testing options,” says Melanie Ott, MD, PhD, director of the Gladstone Institute of Virology and one of the leaders of the study. “The assay we developed could provide rapid, low-cost testing to help control the spread of COVID-19.”

The technique was designed in collaboration with UC Berkeley bioengineer Daniel Fletcher, PhD, as well as Jennifer Doudna, PhD, who is a senior investigator at Gladstone, a professor at UC Berkeley, president of the Innovative Genomics Institute, and an investigator of the Howard Hughes Medical Institute. Doudna recently won the 2020 Nobel Prize in Chemistry for co-discovering CRISPR-Cas genome editing, the technology that underlies this work.

Not only can their new diagnostic test generate a positive or negative result, it also measures the viral load (or the concentration of SARS-CoV-2, the virus that causes COVID-19) in a given sample.

“When coupled with repeated testing, measuring viral load could help determine whether an infection is increasing or decreasing,” says Fletcher, who is also a Chan Zuckerberg Biohub Investigator. “Monitoring the course of a patient’s infection could help health care professionals estimate the stage of infection and predict, in real time, how long is likely needed for recovery.”

A Simpler Test through Direct Detection

Current COVID-19 tests use a method called quantitative PCR—the gold standard of testing. However, one of the issues with using this technique to test for SARS-CoV-2 is that it requires DNA. Coronavirus is an RNA virus, which means that to use the PCR approach, the viral RNA must first be converted to DNA. In addition, this technique relies on a two-step chemical reaction, including an amplification step to provide enough of the DNA to make it detectable. So, current tests typically need trained users, specialized reagents, and cumbersome lab equipment, which severely limits where testing can occur and causes delays in receiving results.

As an alternative to PCR, scientists are developing testing strategies based on the gene-editing technology CRISPR, which excels at specifically identifying genetic material.

All CRISPR diagnostics to date have required that the viral RNA be converted to DNA and amplified before it can be detected, adding time and complexity. In contrast, the novel approach described in this recent study skips all the conversion and amplification steps, using CRISPR to directly detect the viral RNA.

“One reason we’re excited about CRISPR-based diagnostics is the potential for quick, accurate results at the point of need,” says Doudna. “This is especially helpful in places with limited access to testing, or when frequent, rapid testing is needed. It could eliminate a lot of the bottlenecks we’ve seen with COVID-19.”

Parinaz Fozouni, a UCSF graduate student working in Ott’s lab at Gladstone, had been working on an RNA detection system for HIV for the past few years. But in January 2020, when it became clear that the coronavirus was becoming a bigger issue globally and that testing was a potential pitfall, she and her colleagues decided to shift their focus to COVID-19.

“We knew the assay we were developing would be a logical fit to help the crisis by allowing rapid testing with minimal resources,” says Fozouni, who is co-first author of the paper, along with Sungmin Son and María Díaz de León Derby from Fletcher’s team at UC Berkeley. “Instead of the well-known CRISPR protein called Cas9, which recognizes and cleaves DNA, we used Cas13, which cleaves RNA.”

In the new test, the Cas13 protein is combined with a reporter molecule that becomes fluorescent when cut, and then mixed with a patient sample from a nasal swab. The sample is placed in a device that attaches to a smartphone. If the sample contains RNA from SARS-CoV-2, Cas13 will be activated and will cut the reporter molecule, causing the emission of a fluorescent signal. Then, the smartphone camera, essentially converted into a microscope, can detect the fluorescence and report that a swab tested positive for the virus.

“What really makes this test unique is that it uses a one-step reaction to directly test the viral RNA, as opposed to the two-step process in traditional PCR tests,” says Ott, who is also a professor in the Department of Medicine at UCSF. “The simpler chemistry, paired with the smartphone camera, cuts down detection time and doesn’t require complex lab equipment. It also allows the test to yield quantitative measurements rather than simply a positive or negative result.”

The researchers also say that their assay could be adapted to a variety of mobile phones, making the technology easily accessible.

“We chose to use mobile phones as the basis for our detection device since they have intuitive user interfaces and highly sensitive cameras that we can use to detect fluorescence,” explains Fletcher. “Mobile phones are also mass-produced and cost-effective, demonstrating that specialized lab instruments aren’t necessary for this assay.”

Accurate and Quick Results to Limit the Pandemic

When the scientists tested their device using patient samples, they confirmed that it could provide a very fast turnaround time of results for samples with clinically relevant viral loads. In fact, the device accurately detected a set of positive samples in under 5 minutes. For samples with a low viral load, the device required up to 30 minutes to distinguish it from a negative test.

“Recent models of SARS-CoV-2 suggest that frequent testing with a fast turnaround time is what we need to overcome the current pandemic,” says Ott. “We hope that with increased testing, we can avoid lockdowns and protect the most vulnerable populations.”

Not only does the new CRISPR-based test offer a promising option for rapid testing, but by using a smartphone and avoiding the need for bulky lab equipment, it has the potential to become portable and eventually be made available for point-of-care or even at-home use. And, it could also be expanded to diagnose other respiratory viruses beyond SARS-CoV-2.

In addition, the high sensitivity of smartphone cameras, together with their connectivity, GPS, and data-processing capabilities, have made them attractive tools for diagnosing disease in low-resource regions.

“We hope to develop our test into a device that could instantly upload results into cloud-based systems while maintaining patient privacy, which would be important for contact tracing and epidemiologic studies,” Ott says. “This type of smartphone-based diagnostic test could play a crucial role in controlling the current and future pandemics.”

About the Research Project

The study entitled “Amplification-free detection of SARS-CoV-2 with CRISPR-Cas13a and mobile phone microscopy,” was published online by Cell on December 4, 2020.

Other authors of the study include Gavin J. Knott, Michael V. D’Ambrosio, Abdul Bhuiya, Max Armstrong, and Andrew Harris from UC Berkeley; Carley N. Gray, G. Renuka Kumar, Stephanie I. Stephens, Daniela Boehm, Chia-Lin Tsou, Jeffrey Shu, Jeannette M. Osterloh, Anke Meyer-Franke, and Katherine S. Pollard from Gladstone Institutes; Chunyu Zhao, Emily D. Crawford, Andreas S. Puschnick, Maira Phelps, and Amy Kistler from the Chan Zuckerberg Biohub; Neil A. Switz from San Jose State University; and Charles Langelier and Joseph L. DeRisi from UCSF.

The research was supported by the National Institutes of Health (NIAID grant 5R61AI140465-03 and NIDA grant 1R61DA048444-01); the NIH Rapid Acceleration of Diagnostics (RADx) program; the National Heart, Lung, and Blood Institute; the National Institute of Biomedical Imaging and Bioengineering; the Department of Health and Human Services (Grant No. 3U54HL143541-02S1); as well as through philanthropic support from Fast Grants, the James B. Pendleton Charitable Trust, The Roddenberry Foundation, and multiple individual donors. This work was also made possible by a generous gift from an anonymous private donor in support of the ANCeR diagnostics consortium.

About Gladstone Institutes

To ensure our work does the greatest good, Gladstone Institutes focuses on conditions with profound medical, economic, and social impact—unsolved diseases. Gladstone is an independent, nonprofit life science research organization that uses visionary science and technology to overcome disease. It has an academic affiliation with UC San Francisco.

Sources

Gladstone Institutes: Julie Langelier | julie.langelier@gladstone.org | 415.734.5000

UC Berkeley: Kara Manke | kjmanke@berkeley.edu | 415.502.4608

SOURCE Gladstone Institutes; University of California, Berkeley

Related Links

https://gladstone.org

The post New CRISPR-Based Test for COVID-19 Uses a Smartphone Camera appeared first on Medika Life.

BillionToOne’s unique testing protocol removes costly, time-consuming step of RNA extraction and significantly expands testing capacity

Date of Release: Sept 7, 2020

MENLO PARK, Calif/PRNewswire/ — Today, BillionToOne, Inc., the precision diagnostics company, received Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for their groundbreaking SARS-CoV-2 diagnostic test which eliminates the costly and time-consuming step of RNA extraction. As opposed to most other molecular assays that rely on RNA extraction and qRT-PCR, BillionToOne’s qSanger-COVID-19 assay uses a different set of instruments and chemicals from existing tests, therefore enabling labs to unlock a new, unused capacity for the detection of SARS-CoV-2, the virus that causes COVID-19. The test is easily adaptable with minimum training at any laboratories with Sanger Sequencers, which most major clinical laboratories have readily available. 

By utilizing Swift Biosciences’ unique custom manufacturing and distribution expertise, BillionToOne completed the development of its COVID-19 assay kits and began international distribution in May. DASA, the biggest medical diagnostics laboratory in Brazil, has already adopted BillionToOne’s qSanger-COVID-19 assay.

“Since March 2020, we have experienced a severe shortage of RT-PCR consumables, which is seriously restricting our capacity to provide molecular testing in Brazil. The qSanger-COVID-19 allowed us to increase the throughput while using reagents and equipment that do not compete with the RT-PCR needs. The BillionToOne team gave us support during all steps of the implementation and validation,” said Dr. Jose Levi, Head of Innovation in Clinical Analysis at DASA.

“A critical element of combating COVID-19 and enabling communities and economies to reopen is our ability to deliver widespread, cost-effective diagnostic testing across the United States and globally,” said Dr. Oguzhan Atay, CEO of BillionToOne. “With the emergency use authorization of our RNA extraction-free tests, we can now roll out the test in US laboratories in addition to international labs. We’re proud to be on the front lines of the effort to confront the coronavirus pandemic and have now unlocked a cost-effective, scalable way to expand testing in all major laboratories.”

BillionToOne developed the test based on their patent-pending qSanger™ technology. This test adopts the technology behind the Human Genome Project – Sanger sequencing – to the reliable detection of viral RNA. This approach vastly increases testing capacity because a single sequencer can process an average of 4,000 tests per day – 20 times more than qRT-PCR instruments. BillionToOne’s testing method also removes the costly, time-consuming process of RNA extraction, making BillionToOne’s tests more cost-effective, highly scalable, and requiring less manpower to conduct. The removal of the RNA extraction process also removes a critical bottleneck in expanding testing capacity across the United States.

BillionToOne and Swift Biosciences are currently working together with multiple clinical laboratories in the US and around the world to help them adopt the testing protocol. 

About BillionToOne

BillionToOne, headquartered in Menlo Park, California, is a precision diagnostics company with a mission to make molecular diagnostics more accurate, efficient, and accessible for all. The company’s patent-pending QCT molecular counter platform is the only technology platform that can accurately count DNA molecules to the single-count level. BillionToOne’s flagship product, UNITY, is the first and only noninvasive prenatal screening that tests fetal cell-free DNA for cystic fibrosis (CF) and spinal muscular atrophy (SMA) through a single sample of the mother’s blood. BillionToOne was co-founded by Oguzhan Atay, Ph.D., and David Tsao, Ph.D. For more information, visit www.billiontoone.com.

Inquiries:

For any questions regarding partnership and test adoption, please contact covid19@billiontoone.com. 

For any media inquiries, contact media@billiontoone.com

The post FDA grants yet another EUA for RNA Extraction-Free Covid-19 Assay appeared first on Medika Life.

• INO-4800 showed durable antibody and T cell responses in rhesus macaques for 4 months
• INO-4800 is the only vaccine to demonstrate long-term protection in non-human primates challenged with SARS-CoV-2 virus 13 weeks from vaccination
• Memory T and B cell responses resulted in reduced viral loads and faster viral clearance in macaques’ lungs and nasal passages
• INO-4800 vaccination generated antibodies neutralizing both the earlier strain of virus as well as the mutant variant (D614G) that has emerged with greater infectivity, and now accounts for >80% of newly circulating virus
• No antibody-dependent enhanced disease events were reported

DATE OF RELEASE: July 30, 2020

PLYMOUTH MEETING, Pa. /PRNewswire/ — INOVIO (NASDAQ:INO), a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced that its COVID-19 DNA vaccine INO-4800 targeting SARS-CoV-2 was effective in protecting non-human primates (NHPs; specifically rhesus macaques) from live virus challenge 13 weeks after the last vaccination. These protective results were mediated by memory T and B cell immune responses from INO-4800 vaccination.

These results, submitted to a peer-reviewed journal and also published today on the non-peer reviewed online preprint site bioRxiv, demonstrate that INO-4800 reduced viral load in both the lower lungs and nasal passages in macaques that received two doses of INO-4800 (1 mg) four weeks apart and then were challenged with live virus 13 weeks after the second dose (study week 17). The reduced viral loads following exposure to SARS-CoV-2 infection at this timeframe demonstrate an important durable impact mediated by INO-4800.  This is the first time a vaccine protection in non-human primates was reported from memory immune responses as previously reported monkey vaccine challenge studies were conducted at the time near their peak immune responses (1-4 weeks from their last vaccination).

INO-4800-treated animals demonstrated seroconversion after a single vaccination, with protective neutralizing antibodies and T cells lasting in their blood more than four months after the initial dose. The antibody levels were similar to or greater than those seen in patients who have recovered from COVID-19, the infection caused by SARS-CoV-2, and the T cell responses were significantly higher than those from convalescent patients.

Dr. J. Joseph Kim, President and Chief Executive Officer of INOVIO, said, “All other previously reported NHP vaccine protection studies actually challenged the animals at the peak of their immune response.  Our study demonstrates that INO-4800 could provide protection in a more real-world setting, where vaccine-generated memory immune responses protected NHPs for more than 3 months (13 weeks) from the last vaccination. Given the importance of protective antibody and T cell responses, this study gives us more confidence as we continue to advance INO-4800 in the clinic. We believe INO-4800 holds significant potential to help address this global public health crisis.”

B cells are responsible for producing the antibodies that recognize SARS-CoV-2, while T cells play a role in killing the virally infected cells as well as supporting the B cell response. The published data support that immunization with INO-4800 limits active viral replication and has the potential to reduce severity of disease, as well as reduced viral shedding in the nasal cavity. In the study, researchers assessed the ability of INO-4800 to induce acute and memory T cell and B cell immune responses, including neutralizing antibody responses against both early virus as well as now-dominant G614 mutant variants. To INOVIO’s knowledge, this is the first report of vaccine-induced responses driving immunity against G614 variants. A strong anamnestic or memory T and B cell responses were demonstrated following challenge with the live virus.

“As we eagerly anticipate initiating a Phase 2/3 efficacy trials this summer, an animal challenge is currently the closest thing we have to testing a vaccine’s efficacy when confronting a live virus. We are very encouraged with the duration of protection that INO-4800 demonstrated in this NHP study and look forward to reassessing its impact on durability of response at 12 months out from our other ongoing non-human primate and animal challenge studies,” said Dr. Kate Broderick, Ph.D., INOVIO’s Senior Vice President, Research & Development.

“In addition to safety and efficacy, it is essential that any vaccine targeting SARS-CoV-2 generates a relevant durability of response,” Dr. Broderick added. “A vaccine that only provides protection for a very short period of time is not going to realistically solve the problem of this pandemic.”

A separate NHP study evaluating the durability of INO-4800 at 12 months after vaccination is currently under way. INO-4800 also has been selected by U.S. Operation Warp Speed for its COVID-19 non-human primate challenge study.

In May, the peer-reviewed journal Nature Communications published an INOVIO study (“Immunogenicity of a DNA vaccine candidate for COVID-19”) showing that vaccination with INO-4800 generated robust binding and neutralizing antibody and T cell responses in mice and guinea pigs. The study was funded by a grant from the Coalition for Epidemic Preparedness Innovations (CEPI).

About INO-4800

INO-4800 is INOVIO’s DNA vaccine candidate created to protect against the novel coronavirus SARS-CoV-2, which causes COVID-19. INO-4800 is currently in Phase 1 trials in the U.S. and a Phase 2/3 trial is planned for the summer. Interim Phase 1 results showed a favorable safety profile and strong immunogenicity, including antibody and T cell responses. The Phase 1 study recently expanded to include adults over the age of 65 with no age limit given the propensity for COVID-19 to severely impact the health of older people. INO-4800 also is in Phase 1/2 trials for COVID-19 in South Korea and China.

In animal studies, INO-4800 has demonstrated robust and durable T cell and B cell acute and memory responses in a non-human primate challenge study showing protective immune responses in both nasal passages and lungs. INO-4800 also was selected by U.S. Operation Warp Speed for its COVID-19 non-human primate challenge study.

INO-4800 was designed using INOVIO’s proprietary DNA medicine platform rapidly after the publication of the genetic sequence of SARS-CoV-2. INOVIO has extensive experience working with coronaviruses and is the only company with a Phase 2 vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS).

INO-4800 is the only nucleic-acid based vaccine that is stable at room temperature for more than a year and does not need to be frozen in transport of storage, which are important factors when implementing mass immunizations.

About INOVIO’s DNA Medicines Platform

INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. Department of Defense. DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

INOVIO’s DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO’s proprietary hand-held smart device called CELLECTRA^®. The CELLECTRA device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. Administration with the CELLECTRA device ensures that the DNA medicine is efficiently delivered directly into the body’s cells, where it can go to work to drive an immune response. INOVIO’s DNA medicines do not interfere with or change in any way an individual’s own DNA. The advantages of INOVIO’s DNA medicine platform are how fast DNA medicines can be designed and manufactured; the stability of the products, which do not require freezing in storage and transport; and the robust immune response, safety profile, and tolerability that have been demonstrated in clinical trials.

With more than 2,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs.

About INOVIO

INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response. Specifically, INOVIO’s lead candidate VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18 in a Phase 2b clinical trial. High-risk HPV is responsible for 70% of cervical cancer, 91% of anal cancer, and 69% of vulvar cancer. Also in development are programs targeting HPV-related cancers and a rare HPV-related disease, recurrent respiratory papillomatosis (RRP); non-HPV-related cancers glioblastoma multiforme (GBM) and prostate cancer; as well as externally funded infectious disease DNA vaccine development programs in Zika, Lassa fever, Ebola, HIV, and coronaviruses associated with MERS and COVID-19 diseases. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/Department of Defense (DOD), GeneOne Life Science/VGXI, HIV Vaccines Trial Network, International Vaccine Institute (IVI), Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Roche/Genentech, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. INOVIO also is a proud recipient of 2020 Women on Boards “W” designation recognizing companies with more than 20% women on their board of directors. For more information, visit www.inovio.com.

CONTACTS:
Media: Jeff Richardson, 267-440-4211, jrichardson@inovio.com
Investors: Ben Matone, 484-362-0076, ben.matone@inovio.com

This press release contains certain forward-looking statements relating to our business, including our plans to develop DNA medicines, our expectations regarding our research and development programs, including the planned initiation and conduct of preclinical studies and clinical trials, and the availability and timing of data from those studies and trials. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or our collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

The post INOVIO’s COVID-19 Vaccine Shows Durable Antibody and T Cell Responses appeared first on Medika Life.

DATE OF RELEASE: Jul 24, 2020, 07:30 ET

GLEN ALLEN, Va. /PRNewswire/ — TCA/ GENETWORx Laboratories announced today that it has added substantial testing capacity and is now providing COVID-19 diagnostic test results in 72 hours or less to help battle the surging coronavirus epidemic. TCA/GENETWORx has performed thousands of COVID-19 tests since March and recently experienced some delays, like most other United States laboratories. In order to supply results in 72 hours or less, TCA/GENETWORx invested millions of dollars in real estate and equipment and has recruited hundreds of employees. TCA/GENETWORx is now one of the only companies in America that can confidently deliver COVID-19 test results within 72 hours from receipt of sample.

In partnership with Nucleus, TCA/GENETWORx has also created a test and sample management program called Aura. By having all patients download Aura, TCA/GENETWORx provides patients and customers including healthcare providers, universities, government, assisted living facilities, nursing homes, and other large population organizations a total end to end digital management and medical data system which provides test locations, test scheduling, sample tracking, symptom tracking, contact tracing assistance, dashboard compliance reporting, and government reporting.

Aura expedites turnaround times, reduces laboratory process time, and allows large population customers, including municipalities, state and federal governments, universities, large corporations, and others to manage the COVID-19 compliance and health of their entire workforce, student, and/or patient population.

TCA/GENETWORx has also developed an end to end program to test large inner-city populations in order to greatly reduce testing inequality. According to Brian O’Neill, Chairman of TCI/GENETWORx, this specialized testing for the inner city is desperately needed, “The age-adjusted COVID-19 death rate for African American people is 3.6 times that for whites, and the age-adjusted death rate for Hispanic/Latino people is 2.5 times that for whites. This is unconscionable and we are offering U.S. cities a managed testing solution to address this problem on a large scale.” 

The company is building capability to perform 870,000 tests per day or 26 million per month. In order to meet demand, the company launched a massive recruiting campaign called Re Employ America and is currently extending offers to 50-100 people per day. Moreover, in the company’s Glen Allen, Virginia laboratory, the TCA/GENETWORx “Families Work Here” program employs multiple generations of families. This has instilled an “all hands on deck” culture at the company which has helped it to grow to meet the demand required by the pandemic.

CEO and Co-Founder of GENETWORx William Miller is a member of one of the multi-generational families working together at Genetworx.

“I’m happy to support the U.S. and Virginia economies through our Re Employ America campaign and I’m proud to have members of my family working side by side with me at TCA/GENETWORx to help battle this pandemic,” said Miller.

Another multi-generational family employed by the company includes twenty-year laboratory testing veteran and Chief Laboratory Officer Sarah Jacobs-Helber. “My daughter and my son work here in the medical technology and operations departments. We all feel a tremendous sense of pride that we are contributing in a very real way in our different job roles at Genetworx as we all work together to perform the vital service of testing hundreds of thousands of Americans during this crisis,” she said.

Miller, who cofounded Genetworx in 2013 with two other scientists added “The heart of our lab is full of national pride and that comes from starting out as a smaller lab whose employees really want to make a difference during the country’s infectious disease crisis.”   

Please visit Genetworx.com for further information on hiring or to order testing. To keep up with the latest news about Genetworx, please follow us on Linked In. For media interviews contact: Terri C.Malenfant at tmalenfant@recoverycoa.com.

The post COVID-19 Testing with 72 Hour or Less Turnaround Time appeared first on Medika Life.