WCCT Provides an Update on Clinical Trial Operations including new COVID-19 Testing Procedures
[Monday, January 4, 2021] Since re-opening its Phase 1 clinical pharmacology unit 9 months ago, WCCT Global has conducted over 20,000 COVID-19 tests and has maintained a low positivity rate of 0.7%. During that time, the company had adapted its procedures to meet its evolving operational needs, while evaluating the effectiveness of each testing platform and responding to the ever-changing status of the SARS-CoV-2 pandemic.
As an update to the below information, the company would like to report the following changes to its testing platform:
- Effective November 1, 2020, the Epitope Diagnostics ELISA testing was removed from the standard menu, while still being available upon Sponsor request. While the test was intended to provide surveillance details and monitor trends towards infection, the company has opted to deploy both its Rapid Test and PCR Testing more frequently and with more expedited results.
- In the event of inconclusive Rapid Antibody Test results, WCCT now has the ability to deploy an Antigen Test using the BD Veritor System, which is able to detect the presence of an active virus, as a confirmatory testing measure with a quick turnaround time for results. The Rapid Antibody Test, while extremely accurate, relies upon the presence of antibodies after exposure to the virus, which could yet be undetectable when tested. In contrast, the Antigen Test detects the presence of viral proteins, allowing WCCT to determine the true clinical status of the subject or employee with greater accuracy and earlier than an antibody test would demonstrate.
Cypress, CA., April 13, 2020/ PRWeb/ — WCCT Global, a full service CRO which operates a clinical pharmacology unit in Orange County, CA, announced today its ability to now screen for the presence of SARS-CoV-2 (the virus responsible for COVID-19 disease) in clinical trial subjects and staff will enable operations to incrementally re-start following a carefully monitored virus testing strategy.
Kevin Noble, WCCT’s Director of Laboratory Operations, stated “We will be simultaneously implementing three testing platforms that will allow our subjects, employees, and Sponsors the peace of mind to know we are conducting our trials in the safest manner possible by methodically monitoring for the Virus throughout the entire trial.”
20/20 BioResponse’s CoronaCheck COVID-19 Rapid Antibody Test Kit will be the platform most widely used; it will be used for rapid screening to detect for potential carriers of the virus that are either symptomatic or asymptomatic. The CoronaCheck will enable WCCT medical staff to quickly screen potential study subjects for the virus before allowing them to participate in a trial. The turnaround time for the trial is 15 minutes. Any positive result will be confirmed by molecular testing and will result in the volunteer being sent home for at least two weeks before being retested and cleared for participation. Fellow subjects and staff potentially exposed will be tested as well, ensuring the facility remains safe for all participants.
The Epitope Diagnostics’ Novel Coronavirus COVID-19 IgM ELISA Kit will be the second diagnostic test to be deployed. It enables the semi-quantitative measurement of the COVID-19 IgM antibody in serum, utilizing an enzyme immunoassay technique. The test has a turnaround time of two hours. WCCT began using this kit to test all staff at its clinical pharmacology unit on March 23, 2020 and will use this platform to provide a baseline and ongoing monitoring for the health of its employees and subjects. This test also provides the clinical staff the ability to monitor for the Coronavirus in study participants throughout the duration of the trial, as it can give quantitative measurements of any early immune response to the virus.
The third testing platform is the same methodology that has received full FDA approval and is being utilized by the Center for Disease Control (CDC). In order to bring this testing in-house at its Safety Reference Laboratory, WCCT signed an agreement with Thermo Fisher Scientific to bring in two new instruments: Applied Biosystem 7500 Fast DX and King Fisher Flex. In late March, WCCT performed a live validation of the test using positive samples, in accordance with the FDA’s Standard Operating Procedure for molecular analysis of COVID-19, which is also used to determine approvals for future testing and methodologies. The turnaround time for this test is 24 hours.
When asked how the implementation of the tests would affect safety at WCCT’s facility, the company’s Chief Medical Officer, David Nguyen, MD, stated “Safety is paramount to our operations here at WCCT—safety for our subjects, for our employees, and for their families. We understand the need to conduct critical clinical trials during this pandemic and we are hopeful that these added safety measures will allow us to advance healthcare during this difficult time.”
WCCT’s President and Chief Scientific Officer, Mel Affrime, PharmD went on to say “I applaud the tireless efforts of our reference laboratory leadership and staff. They have managed to launch three different and highly sophisticated testing platforms for COVID-19 within a 3-week timeframe. This accomplishment will enable WCCT to continue to carry on with our Corporate Mission: To Achieve our Sponsors’ Early Phase clinical objectives of advancing global health.”
On April 13, 2020, WCCT resumed its clinical trial operations at its clinical pharmacology unit, using these three new testing procedures for COVID-19 to enable its Sponsors to continue advancing their pipelines, especially those companies which are currently developing vaccines and anti-viral therapies targeting COVID-19.
About WCCT Global Inc.
WCCT is a full service CRO for the pharmaceutical, biotechnology and medical device industries. We are specialized regulatory and clinical development professionals who offer an innovative, agile and collaborative approach to every program we deliver. Our mission is to achieve our Sponsors’ Early Phase clinical objectives of advancing global health. This is accomplished through the development of a scientifically informed time and budget-sensitive design; and with clinical trial research service execution that delivers high quality data, a superior client experience, and a volunteer-centric approach to care.