Sunday, July 05, 2020

Lab-on-a-Chip (LoC) COVID-19 Test Advances to Clinical Trials

In July, Dr. Pantelis Georgiou’s research group from Imperial College London will begin testing the accuracy of a “lab-on-a-chip” COVID-19 diagnostic test in clinical trials at Charing Cross Hospital in London. This inexpensive test provides a result in 20 minutes, relies on smartphone technology and can be used in remote locations without access to electricity. The only reliance on electricity is for charging the internal battery.

The test involves loading extracted DNA and RNA from a nasal or throat swab onto a single-use disposable cartridge. The cartridge is loaded onto the LoC device, which contains an array of ion-sensitive field-effect transistor (ISFET) sensors integrated on a complementary metal-oxide semiconductor (CMOS). The single-use cartridge with the CMOS is plugged into the main device. The main device contains a microcontroller, similar to a small computer, that acquires and processes the data. The microcontroller also transfers the data retrieved from the test via Bluetooth to a smartphone app and secure cloud server.

Each ISFET sensor measures ion concentrations in solution. When the ion concentration changes, the current in each sensor or pixel varies as well. An ISFET is similar to a metal-oxide-semiconductor field-effect transistor (MOSFET). The difference is that in an ISFET, the gate connection is tied to a reference electrode in contact with the solution. Also, the gate oxide is replaced with an ion-sensitive insulating layer.

CMOS is a technology that enables microchips to acquire, store and transmit large amounts of information. The CMOS for this particular test contains over 4,000 electrochemical sensors.

The sensors allow ion imaging of the reaction on the surface of the chip. If the sample contains the RNA of the active virus, the device performs an amplification reaction and protons are released in the solution. When the concentration of hydrogen ions increases, the pH drops. Thus, the solution becomes more acidic.

“One of the benefits of using smartphone technology is that everyone has such a device in their pocket,” said Dr. Nicolas Moser, research associate at the Department of Electrical and Electronic Engineering at Imperial College London and a member of the team.  “With a custom app, a smartphone can be used to implement advanced algorithms to process the data.”

Moser added that a handheld device is cheaper than using a computer. With only a single battery, a doctor could administer multiple tests at once.

“Each lab-on-chip (LoC) cartridge contains a control sample to ensure that the result from the swab is accurate,” Moser said. “During our clinical validation, we will also measure the results of the validation with an analysis from a quantitative polymerase chain reaction machine (qPCR machine), which amplifies and detects DNA. In addition, we will use other gold-standard methods of virus detection to validate the performance of our LoC test.”

The team is currently working to ensure the chip’s seal is reliable. A tight seal will prevent contamination of the sample.

“We’ve switched to 3D printing from our previous manufacturing technology and adopted a new design,” said Matthew Cavuto, a graduate student and research assistant on the team. “Luckily our 3D printer, the Figure 4 from 3D Systems, can print our microfluidic chips very quickly. Between March and June of 2020, we went through probably 30 versions of the design. That’s been our primary troubleshooting technique, iterating and experimentally testing as rapidly as possible.”

The current test was developed from technology the team started researching two years ago. The technology was originally designed to address outbreaks of the Zika virus.

“The LoC has the advantage of offering versatility to a wide range of infectious diseases,” Moser said. “It was designed to detect dengue and trialed in Taiwan and, later, malaria and trialed in Ghana. In March 2020, we adapted the test to detect the novel coronavirus.”

Moser and Cavuto said Imperial College London has allowed the team access to the lab through the pandemic. Work conditions have been similar to those under normal circumstances, except for new requirements to socially distance and wear masks and gloves at all times.

“At times, we had difficulty obtaining printed circuit boards and electronics from China,” Cavuto said. “Their manufacturing facilities were closed.”

The team has been able to continue research because the project is deemed essential to the current COVID-19 pandemic.

Moser said that during and after the clinical trials, the team will develop training to teach healthcare providers how to administer tests. The team is also determining how to synchronize data from tests and store them on a secure cloud server.

“We further hope to take the anonymous information retrieved from the tests and synchronize it onto a global map that we’ve developed,” Moser said. “That will track the evolution of data in a completely automated way. It will give countries reliable information to make decisions regarding public health.”

The current members of the research group are Georgiou, Dr. Jesus Rodriguez Manzano, Moser, Cavuto, Ivana Pennisi, Kenny Malpartida Cardenas, Ahmad Moniri and Luca Miglietta. To learn more about the Imperial College London team’s research, read their published papers on rapid detection and mobile detection system.

GenMark Diagnostics Announces Launch of its ePlex® Respiratory Pathogen Panel 2 (RP2)

GenMark Diagnostics, Inc., a leading provider of automated, multiplex molecular diagnostic testing systems, announced that its ePlex® Respiratory Pathogen 2 (RP2) Panel is now available for U.S. commercial distribution and clinical use. The ePlex RP2 Panel is one of the first rapid-result multiplex panel tests that can identify 21 pathogens, including SARS-CoV-2, to be made available for clinical use. The company also submitted an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration for the ePlex® Respiratory Pathogen 2 (RP2) Panel earlier this month.

The ePlex RP2 Panel is designed to provide results for SARS-CoV-2 – the virus that causes COVID-19 – in addition to a number of other common respiratory pathogens, including influenza, adenovirus, rhinovirus and respiratory syncytial virus (RSV), in under two hours. The panel also includes a new, simplified workflow making it even easier for labs to run the test. The ability to quickly determine the cause of infections will be vital in the fall and winter when many of these respiratory pathogens are likely to be circulating, along with SARS-CoV-2.

Incorporating the SARS-CoV-2 assay into the existing ePlex RP Panel is intended to streamline the diagnostic process for hospitals by allowing them to check for multiple pathogens with a single test, saving time and resources and improving bed management. A study at two acute large tertiary care hospitals demonstrated that using the ePlex RP panel in the Emergency Department led to earlier patient results which resulted in an 8.4% reduction in hospital admissions.1

“The ePlex RP2 Panel is designed to enable clinicians to quickly determine the cause of infection and the best course of treatment. This is especially vital for individuals who are vulnerable, such as the elderly, people with compromised immune systems, and children, and therefore at increased risk for the new coronavirus and other common and often serious respiratory illnesses,” said Scott Mendel, President and CEO of GenMark. “One recent study highlighted that about 20% of COVID-19 patients are also infected with other respiratory pathogens.2 Syndromic panels that provide broad coverage of viruses and bacteria from one patient sample will be critical this flu season, which is expected to coincide with continued SARS-CoV-2 infections.”

Incorporating the SARS-CoV-2 test into the existing ePlex RP Panel is expected to improve GenMark’s manufacturing efficiency and output and increase the number of respiratory panels (including COVID-19 tests) the company can supply. GenMark continues to invest in manufacturing capacity improvements to scale and meet future testing demand.

The ePlex RP2 Panel is designed for use with the company’s ePlex system, which has been cleared by the FDA for use with the ePlex Respiratory Pathogen (RP) Panel and Blood Culture Identification (BCID) Panels (Gram-positive, Gram-negative and Fungal pathogens). In March, GenMark received EUA for its ePlex SARS-CoV-2 Test. Certified by the FDA under the Clinical Laboratory Improvement Amendments (CLIA) as moderately complex, the ePlex system is easy to operate and can be used in a wide variety of hospital and reference lab settings.

Tangen Biosciences Awarded a Contract for Point-of-Care Detection of Candida auris

Tangen Biosciences, Inc. announced that it was awarded a contract by the New York State Department of Health’s Wadsworth Center in conjunction with Health Research Inc. to develop a point-of-care device for detection of Candida auris, a “superbug” that is resistant to anti-fungal drugs and is emerging as a public health threat. According to the CDC, New York State has the most Candida auris cases in the United States. Tangen™ was selected as one of the three awardees for this contract to join forces with the Wadsworth Center to fight against this drug resistant fungus. Tangen will independently develop a skin-swab based Candida auris assay running on its portable GeneSparkTM instrument and will also develop a swab-based Candida auris test for environmental surveillance.

Tangen has developed a molecular diagnostic platform called TangenDx™ – a small footprint, rapid, highly sensitive, and low-cost system. TangenDx is composed of an assay kit and a GeneSpark analyzer. The TangenDx has been developed for rapid diagnosis of bloodstream candida infections, bacterial infections including Bacillus anthracis, and an antimicrobial-resistant panel directly from whole blood in less than one hour. During the COVID-19 pandemic, Tangen has focused on developing a point-of-care SARS-CoV-2 assay and intends to submit an Emergency Use Authorization notification to FDA within the next month. Tangen’s new contract with Wadsworth Center is expected to further expand Tangen’s product pipeline to include a clinical as well as an environmental Candida auris test. The high sensitivity, portability, and speed provided by the TangenDx platform is expected to facilitate a faster and more accurate diagnosis of Candida auris, allowing for an improved response to outbreaks of this threat.

The current Tangen bloodstream candida panel used on the TangenDx can detect fewer than 5 CFU/ml of the five most prevalent Candidiasis species in less than one hour from a whole blood sample without culture. “We are building upon the foundation of Tangen’s existing Candida Bloodstream Infection diagnostic assay, and predict we can rapidly develop a Candida auris test for both blood and skin swab samples with very low risk and achieve high sensitivity and specificity,” Dr. John Davidson, Chief Scientific Officer of Tangen and the Principle Investigator of this contract, stated. “Rapidly detecting Candida auris is crucial to control its spread in hospitals and the community, including nursing homes, which have been identified as incubators for this superbug. We are excited to work with the Wadsworth Center to address this very important public health issue."

“New York State’s continued support continues to advance the nation’s efforts to control this fungus that predominantly affects an already vulnerable population, including those in nursing homes and people with compromised immune systems,” said Jill Taylor, Ph.D., Director of the Wadsworth Center. “We look forward to working with Tangen to bring this important tool to frontline health care settings.”

T2 Biosystems Announces U.S. Launch of COVID-19 Diagnostic Test

T2 Biosystems, Inc., a leader in the rapid detection of sepsis-causing pathogens, today announced the completion of validation of its COVID-19 molecular diagnostic test, the T2SARS-CoV-2 Panel. The test was developed by T2 Biosystems under a license agreement with the Center of Discovery and Innovation at Hackensack Meridian Health and is being commercially distributed after validation meeting requirements for an Emergency Use Authorization (EUA) request to FDA.

The T2SARS-CoV-2 Panel is designed to detect SARS-CoV-2, the virus that is responsible for COVID-19 infections. The T2SARS-CoV-2 Panel provides sample-to-answer results in less than two hours, utilizing a nasopharyngeal swab sample. Clinical testing on known positive and negative patient samples showed a sensitivity of 95% and specificity of 100%. The T2SARS-CoV-2 Panel runs on the Company’s FDA-cleared T2Dx® Instrument, which is a fully-automated, random access system capable of performing seven tests simultaneously.

“We are proud to announce the U.S. launch of our molecular diagnostic test, the T2SARS-CoV-2 Panel, which has demonstrated excellent clinical performance. Adding this test to our existing sepsis-related portfolio illustrates our commitment to transformative diagnostics that improve the lives of patients,” said John Sperzel, President and Chief Executive Officer of T2 Biosystems. “Given the susceptibility of critically-ill COVID-19 patients to develop bacterial or fungal co-infections and secondary infections that can lead to sepsis, we believe our platform can be used to identify acute COVID-19 infections, and optimize outcomes for patients under intensive care.”

The T2Dx Instrument can also run the Company’s FDA-cleared T2Bacteria® Panel and T2Candida® Panel. These panels can detect sepsis-causing pathogens, both bacterial and fungal respectively, directly from whole blood in three to five hours, without the need to wait for a blood culture, which typically takes days to provide results and is not as sensitive. By providing quicker results, the panels enable clinicians to target therapy faster than ever for their patients suspected of sepsis, leading to better patient outcomes, improved antibiotic stewardship, and reductions in length of stay in the hospital.

Sherlock Biosciences and binx health Announce Global Partnership to Develop First CRISPR-based Point-of-care Test for COVID-19

Sherlock Biosciences and binx health today announced the companies have entered into a strategic partnership to develop the world’s first rapid, point-of-care diagnostic test for COVID-19 leveraging CRISPR technology. The organizations will combine the binx io diagnostic platform with SHERLOCK™ CRISPR technology to create a test that is robust and simple to use. This unique solution is designed to provide rapid and accurate results in a single patient visit across many diverse CLIA-waived settings, such as clinics, doctors’ offices, assisted living centers, pharmacies and other easily accessible consumer venues, which will assist in broadening ways of managing potential resurgences of the pandemic. The combination of technologies also portends strong positioning for other viral threats as they emerge.

The binx io is the fastest molecular platform in the world that has U.S. Food and Drug Administration (FDA) clearance for chlamydia and gonorrhea testing. The Company’s platform is based on a proprietary detection method that makes it suitable for broad application across infectious diseases. The platform has a demonstrated ability to rapidly detect complex infectious disease targets from bodily fluids with very high accuracy. The binx io molecular platform consists of an easy-to-use, desktop-sized instrument and single-use cartridge with multiplex capacity of up to 24 targets. Once a patient sample is added to the cartridge and loaded into the io instrument, the process is fully automated, requires no interpretation of data, and is designed to produce a clearly indicated onscreen “detected” or “not detected” result.

“We are pleased to partner with Sherlock Biosciences to help bridge a gap in COVID-19 testing—the need for highly accurate point-of-care diagnostic testing in CLIA-waived and near-patient settings,” said Jeff Luber, chief executive officer of binx health. “In April of this year, binx health made history with the first 30-minute, FDA-cleared molecular diagnostic instrument for chlamydia and gonorrhea in both men and women that for the first time delivers same-visit diagnoses. Our proprietary platform will now leverage Sherlock’s CRISPR-based assay combined with binx’s electrochemical detection for rapid viral detection of SARS-CoV-2 without the need for additional instrumentation. This union of technologies is designed to enable physicians, clinicians and other healthcare workers on the front lines of the global COVID-19 pandemic to make on-the-spot care decisions and to control and prevent further infections. We also have a unique alignment of vision with Sherlock for solutions that support ‘everywhere’ testing in near-patient retail and clinical settings.”

“This collaboration with binx health to advance our SHERLOCK diagnostic platform and offer an accurate, point-of-care test is the next critical step in combating the global COVID-19 crisis,” said Rahul Dhanda, co-founder, president and CEO of Sherlock Biosciences. “We are also excited to explore with binx how to utilize the io platform to bring accurate and affordable testing to hospitals, urgent care centers and other healthcare facilities for a range of diagnostic tests beyond COVID-19. We agree with the binx strategy that ‘everywhere care’ depends on highly accurate in-clinic and easy-to-use at-home solutions. Through both our SHERLOCK- and INSPECTR™-based platforms, we hope to serve as part of the solution to addressing the COVID-19 pandemic by making accurate, affordable diagnostics available everywhere they are needed: in the lab, point-of-care locales, low-resource settings and the home.”

The currently available Sherlock™ CRISPR SARS-CoV-2 kit uses the SHERLOCK (Specific High-sensitivity Enzymatic Reporter unLOCKing) method to program a CRISPR molecule to detect the presence of a specific SARS-CoV-2 genetic signature in specimens collected from patients suspected of COVID-19 by their healthcare provider. The kit is intended for use in CLIA laboratories to assay nasal swabs, nasopharyngeal swabs, oropharyngeal swabs or bronchoalveolar lavage (BAL) specimens. When the signature is found, the CRISPR enzyme is activated and releases a detectable signal, yielding results in about an hour. The kit is the first CRISPR-based diagnostic test to receive EUA from the FDA for qualitative detection of nucleic acid from SARS-CoV-2. Sherlock is also pressing forward in developing its INSPECTR at-home testing platform to create an instrument-free, handheld test – similar to that of an at-home pregnancy test – for the rapid detection of the SARS-CoV-2 virus.

European Pharmacopoeia Publishes New Chapter Regarding BET Testing and the Use of Recombinant Factor C

The European Pharmacopoeia has released a supplement containing a new general chapter that describes an alternative bacterial endotoxins (BET) test to the classic limulus amoebocyte lysate (LAL)-based method.

The new chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C describes how recombinant factor C (rFC) based on the gene sequence of the horseshoe crab and fluorimetric detection can be used to quantify endotoxins from gram-negative bacteria.

Supplement 10.3 also contains the revised chapter 5.1.10. Guidelines for using the test for bacterial endotoxins, which has been updated to reflect the new status of rFC-based methods and give prerequisites for their deployment by users of the pharmacopoeia.

According to the Council of Europe (EDQM), chapter 2.6.32 has the potential to become a standardised method, which will become official in the 39 signatory countries to the European Pharmacopoeia convention.

BET tests using rFC can be used in the same way as LAL-based methods once they have been demonstrated as fit for purpose with the specific substance or product. The use of rFC for BET testing does not need to be validated, making its implementation easier; however, the replacement of an LAL-based method by an rFC-based method is considered as the use of an alternative method by the EDQM.

BET testing currently relies on two species of horseshoe crab as the sole source of lysate. Both Limulus polyphemus and Tachypleus tridentatus are endangered species and so a more sustainable option has been the topic of controversy. It was said the new chapter marks a significant step towards alleviating the need for these animal resources.

The EDQM’s Director, Susanne Keitel, explained: “When used under appropriate conditions, rFC-based methods provide the same guarantee of a product’s compliance with the test for bacterial endotoxins – and therefore, of its safety for use in patients – as LAL-based methods”.

The new general chapter 2.6.32 and the revised general chapter 5.1.10 will become effective on 1 January 2021.

Sekisui Diagnostics Announces FDA Clearance and CLIA Waiver of the OSOM Ultra Plus Flu A and B Test

The test utilizes traditional lateral flow technology with performance near or exceeding sensitivity of other reader-based tests without using an instrument. It is intended for the qualitative detection of influenza type A and type B nucleoprotein antigens directly from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection.

The clearance of the OSOM Ultra Plus Flu A&B Test heightens the performance of our flu portfolio allowing us to provide a more accurate rapid influenza test kit to many different institutions including nursing homes, chronic care facilities, and hospitals which the CDC acknowledges is useful for public health purposes to detect influenza outbreaks, said Robert Schruender, President and CEO of Sekisui Diagnostics. Accurate diagnosis of influenza is critical to rule in or rule out the flu and can help guide healthcare professionals when trying to diagnose other respiratory infections. This is especially important in our current situation where SARS-CoV-2 Tests are not widely available. We are proud to be able to provide another diagnostic tool which can help protect patients and our communities.

Sekisui Diagnostics offers all three commonly used modalities in the CLIA Waived environment via four different tests OSOM Ultra Plus Flu A&B Test (lateral flow dipstick), OSOM Ultra Flu A&B Test (lateral flow cartridge) Acucy Influenza A&B Test (point-of-care reader) and the Silaris Influenza A&B Test (molecular point-of-care). Sekisui Diagnostics offers more options to address the varying needs of customers to help improve patient outcomes, maximize clinical efficiencies, and reduce operational budgets. Reflecting on the unprecedented respiratory season this year, we have seen the value of tests that can respond to high volume clinical demand no matter where testing occurs, said David Morris, PhD, Sr. Product Manager. Rapid, point-of-care testing continues to be an essential tool in the healthcare system's ability to respond to surges in testing demand and to reduce the spread of respiratory infections.

Testing patients provides valuable information to clinicians that enables treatment decisions and reduces the risk of prescribing unnecessary antivirals, antibiotics or allows them to be referred on for more extensive testing if needed.

Monday, June 22, 2020

Virginia Commonwealth University Researchers Develop Extremely Rapid Experimental COVID-19 Test

Early diagnosis and isolation of patients with COVID-19 is a keystone for controlling the pandemic. While testing capacity has grown, quick turnaround for patient results remains critical.

To address this need, Rebecca Martin, Ph.D., a research member at VCU Massey Cancer Center, developed an extremely rapid experimental molecular diagnostic assay that decreases the amount of time required to diagnose COVID-19.

"When results can be obtained in just a few minutes, diagnosis and treatment can be provided on the initial care visit without sending samples to a central lab," said Martin, an assistant professor in the Department of Microbiology and Immunology at the VCU School of Medicine. "This methodology could provide accurate disease diagnostics on-site."

The project was enabled by a grant from the VCU COVID-19 Rapid Research Funding Opportunity, sponsored by the Office of the Vice President for Research and Innovation and the C. Kenneth and Dianne Wright Center for Clinical and Translational Research. The initiative was established to quickly pivot or expand research addressing the impact of the COVID-19 pandemic on the health system and the community.

Martin worked with VCU M.D.-Ph.D. students Jared Farrar and Joseph Lownik to develop the test by using recent methods of fast nucleic acid amplification to screen for SARS-CoV-2, the causative virus for COVID-19.

Their method is combined with rapid RNA extraction to allow for a total detection time of 3.5 minutes from swab to diagnosis. Compared to conventional testing, this new methodology is significantly faster, making the turnaround time minutes rather than hours.

"[Polymerase chain reaction], a common methodology in research and clinical laboratories, is slow, but sensitive," Martin said. "Antigen-based testing is fast, but not very sensitive. Our technique is both fast and sensitive."

Martin's work builds on research previously conducted by Farrar and Carl Wittwer, M.D., Ph.D., at the University of Utah that demonstrated that PCR—which can produce many copies of a DNA sequence from a small sample—can be performed in 15 to 60 seconds.

"By utilizing the principles of Extreme PCR, our test is currently the fastest described molecular diagnostic test for COVID-19 to our knowledge," Martin said. "Additionally, our technology can be easily multiplexed unlike other rapid molecular diagnostic methods."

Martin has filed provisional patent applications for this technology. She will also need to obtain Food and Drug Administration approval before the tests can be used on patients.

Her laboratory prototype is currently not practical for testing with patients at the point of care but proves that molecular diagnostic testing for COVID-19 can be done much faster than what current modalities are capable of doing.

For the next steps in their research, Martin and her team will work with the VCU Health System to test their prototype on patient samples as well as apply for funding for building a point-of-care prototype.

"We look forward to collaborating with the industry to develop an implementation for use in the clinic for COVID-19 diagnostics, as well as syndromic pathogen panels that can be used in testing for many different respiratory pathogens," she said.

Genetworx Laboratories Announces New COVID-19 Antibody Test with 99.8 Percent Specificity

Genetworx Laboratories, a leading innovative molecular diagnostic testing laboratory, announced today that the company is now performing COVID-19 antibody testing, in addition to diagnostic testing, for the virus. The Virginia-based company stated that it is providing the new antibody blood test in response to the demand from physicians' offices, emergency management providers, government, assisted living entities, and employers all over the United States. The Genetworx Total Antibody (IgM & IgG) test is 99.8% specific and 100% sensitive.

In addition to the new antibody test, the company further announced a comprehensive instant notification system implemented recently in which patients (who opt in) are notified of their test results immediately – for both antibody and diagnostic testing clients. Once Genetworx receives a patient's sample, the test is performed, and results are available through a patient or physician portal, or via text and voice messaging, within 24-48 hours.

Test results were previously sent directly to providers or third-party contractors. However, now, patients themselves can choose to receive their Genetworx COVID-19 test results automatically by text message or through a new interactive voice response telephone messaging system using a personal cellphone. Additionally, test results can be provided online through a patient portal. A certificate of proof of a test result will also be able to printed through the new online portal for employees as they return to work.

"We understand how important COVID-19 test results are to our patients so Genetworx invested in a system allowing rapid notification so that patients can have a diagnosis in the soonest time possible -- immediately after the Laboratory reads the results—usually within 24-48 hours of receipt of the sample," explained William Miller, CEO of Genetworx and a 20-year veteran of the molecular diagnostic laboratory testing industry. "Like all laboratories in the US, we saw a significant increase in volume recently and have worked tirelessly to implement the new system and be as responsive as possible to our patients and providers," he said.

The Genetworx antibody test, like the diagnostic test, is in the 99th percentile for accuracy and has emergency use authorization from the U.S. Food and Drug Administration. COVID-19 antibody tests utilize a patient's blood sample to detect the presence of specific antibodies to show a past infection with the virus. Nearly all immune competent individuals will develop an immune response following SARS-CoV-2 infection. Like infections with other pathogens, a COVID-19 infection creates IgM and IgG antibodies, which are the most useful for assessing antibody response. A patient's physician and the Centers for Disease Control guidelines will help determine the appropriate response to antibody test results.

Miller says that the last few months have been a once-in-a-lifetime experience for him and his staff.

"It's been very exciting for us to work together and play an important role in battling the coronavirus pandemic. Our company is proud that we pivoted quickly and repurposed part of our facilities back in March in order to conduct widespread COVID-19 testing with a 99 percent accuracy rate. Although it was challenging to keep up with the demand and to innovate in order to get both physicians and patients the information they need at the accuracy level required by the pandemic, Genetworx invested in our patients and, with this new rapid notification system and antibody test for our clients, we can assist the nation in moving forward through the pandemic and back to work."

Genetworx was founded to provide pharmacogenomic DNA genotyping to help provide patients with the right medications, at the right dose, and lower overall healthcare expenditures while delivering the best health outcome. The company is a fully integrated CAP/CLIA certified high complexity molecular diagnostic laboratory.

In 2017, the company was purchased by the national substance use disorder treatment network, Recovery Centers of America ("RCA"). Recovery Centers of America operates seven evidence-based addiction treatment facilities in Massachusetts, Pennsylvania, New Jersey and Maryland and is expanding to Chicago, Indianapolis, and Pittsburgh to meet the growing need for substance use disorder services.