Testing strategies and custom assay development for cell and cell-based therapies

Written on May 26, 2021 on Phacilitate by Scott Jones, BBG Vice President of Scientific Affairs, and Anthony Trinh, QualTex Laboratories Senior Manager, Analytical Development, Cell Therapy Reference Laboratory

Cell and cell-based therapies are a novel and growing class of transformative therapies designed to address gaps in traditional treatment strategies. Regulatory approval for cell or cell-based products requires therapeutic developers to have a set of analytical tests to demonstrate safety, purity and potency. These tests must be validated and performed under current good manufacturing practice (cGMP) conditions.

In this whitepaper by BioBridge Global, Scott Jones, VP of Scientific Affairs at BioBridge Global, and Anthony Trinh, Senior Manager, Analytical Development Cell Therapy Reference Laboratory at QualTex Laboratories, go through 5 testing strategies that QualTex Laboratories use to help customers in the cell and cell-based therapy industry. 

Figure 1. Inhibition of PBMCs in response to MSCs

These strategies include:

  • Assay development process
  • Criticality of potency assays
  • Qualitative versus quantitative assays
  • Use of blood screening safety assays
  • Phase appropriate validations

The importance of client-lab collaboration

Written April 20, 2021 on Phacilitate by Ward Carter, Chief Operating Officer, QualTex Laboratories

A six-step roadmap to help you identify a laboratory testing partner

The demand for cell therapy product testing is increasing rapidly, as more researchers begin the process of transitioning their therapies into the commercialisation pipeline. As noted in a recent interview with Phacilitate, the Alliance for Regenerative Medicine reported that between 2015 and 2020 the number of regenerative medicine companies grew from 672 to 1001 and the number of clinical trials from 631 to 1078. All this growth means that there will continue to be a critical need for testing services to ensure safety, efficacy and performance of advanced therapies.

The availability of this type of specialised testing has not kept pace with the demand, so what we have repeatedly seen is that a GMP experienced laboratory focused on early and effective collaboration, plus smooth technology transfer, are critical success factors in helping researchers and therapeutic developers move their therapy toward clinical trials and, hopefully, commercial launch.

The challenge for many therapeutic developers has been the identification and selection of a laboratory for testing and manufacturing support. For this discussion, we are focusing on the laboratory selection process, providing a roadmap to help developers as they navigate the process. Finding the right laboratory can be complicated. To do an RFP, or to not do an RFP, that is the question…

This roadmap is designed to help narrow your search as you begin having conversations with the sales and support teams from the available laboratories. Creating an RFP (request for proposal) or RFI (request for information) can help you refine your needs and requirements and providing this information can also help the laboratory start with a better picture of your needs. Use the roadmap and your requirements document (RFP or RFI) to help identify the best laboratory to help you get your product to market or to help you maintain your product on the market.

Here is a brief roadmap to help researchers and companies that are moving into clinical trials, or even those who have a product in clinical trials, identify a laboratory testing partner that offers customisable solutions and provides a superior testing experience:

  1. Select a GMP experienced lab
  2. Choose your laboratory partner early
  3. Assess technology transfer capability and capacity
  4. Ask for examples of collaborative experience
  5. Intellectual property support
  6. Smaller may be better

1. Select a GMP experienced lab

Many testing providers have extensive lab testing experience, especially in the research setting. The key capability to investigate is how much experience a laboratory has with managing and testing samples that will be used for further manufacturing into advanced therapies, especially if the rare source material is human-based. Having access to GMP testing is a must-have to make the jump from investigation to commercial launch. Obtaining the required global accreditations takes time and considerable effort, which many organisations are not willing or able to do.

2. Choose your laboratory partner early 

Even during your research phase, it will be helpful, and in some cases critical, to identify a laboratory partner early in the process. Collaboration with your identified laboratory partner earlier in the development cycle can help to prepare your therapy for making the jump from research to clinical trials and hopefully following successful trials, to commercialisation.

3. Assess technology transfer capability and capacity

These are critical assessments for the transfer of the test methods that will be required to ‘verify’ your therapy has the right potency and therapeutic material in the product intended for trial use. The FDA has highlighted the impact of critical quality attributes (CQAs). Therapeutic developers need to understand their target indication and identify or develop a clear set of potency assays or functional assays early on to support their regulatory approval.

4. Ask for examples of collaboration experience

Collaboration is communication on steroids, so take the time it takes to assess how well a laboratory embraces collaboration vs telling you how they will ‘perform’ your testing. When we were awarded an MTEC contract in 2016, our focus was on building a strong collaboration between the four companies involved in the contract award and supporting the start-up of our new biomanufacturing facility. A direct benefit of that project was the addition of cellular therapy testing to QualTex’s list of capabilities. We bring the MTEC experience along with years of custom assay development and GMP testing for donated human materials to every customer interaction.

5. Intellectual property support

While different situations may call for different approaches, ‘what is yours is yours, and what ours is ours and what we develop together belongs to both’ is often the best approach we have found in dealing with IP. Most laboratories understand this, but it doesn’t hurt to do your due diligence. As there are no established standards for potency, it is essential that researchers define their own standards that may require multiple assays using different platforms. Potency testing is likely to involve new tests or new combinations of testing, so IP management will be very important. There are also going to be different assays for different time points through the development process. We recommend that you start with functional assays – characterisation and possibly potency – in animal models and then look at other assays at different times for safety, potency and/or characterisation.

6. Smaller may be better

Smaller laboratories are more likely to offer ‘boutique’ support for clinical developers and collaborate more effectively to arrive at an optimal solution to support your therapy development. But don’t forget about the first five things to consider as you evaluate your choices for a laboratory testing provider. As a testing partner, we offer both research-grade and GxP assays. Biotech companies will need both options, based on where they are in the process of developing and commercialising their product – from qualification to quality control and release testing.

Tissue team tops nation in femoral vein recovery

South Texas Blood & Tissue Center’s tissue recovery team has been named the nation’s top program for recovering cardio vascular tissue for CryoLife, an organization that provides tissue for cardiac and vascular surgeries.

Cryolife is recognizing our surgical team with a trophy in celebration of a 5.6% femoral vascular tissue error rate in 2020.

This is a big jump from 2019, when GenCure was ranked 32 out of 41 programs recovering femoral veins.

What changed?

Guillermo Robles, Tissue Recovery Manager, says having a dedicated suite at the Center For Life at University Hospital made a huge impact. 

“Recovering vascular tissue is a delicate process,” he said. “Having a state-of-the-art tissue recovery facility it provides our technicians the best environment for human tissue recovery.”

Along with giving the team appropriate lighting and space to work, there also are fewer distractions from nurses or hospital staff, who check in to see when the operating room will be available for the next surgical case.

Another benefit of the Center For Life recovery suite, which opened in February 2020, is that it reduces the need to travel.

“Previously, if we needed to go to Corpus Christi or Laredo for a recovery, it would be five hours of travel alone,” Robles said. “Tissue recovery often takes three to six hours. That’s a 12- to 16-hour shift for our technicians.”

The team took other steps to improve its recovery error rate. Heart, femoral veins and saphenous veins are delicate tissues that require precise recovery process. The team has dedicated many hours on training and improving their surgical techniques.

The Tissue Recovery Team’s work isn’t just life-enhancing, it’s lifesaving. Femoral veins are often used in heart surgeries for both adults and children.

“Those patients need these tissue grafts to live,” Robles said.

Ultimately, he said, it was the team’s dedication to the BioBridge Global mission of saving and enhancing lives that helped lead to their success.

Developing Risk-Based Testing Strategies for Advanced Therapies

Written April 15, 2021 by Michael Adeniya, Event Director, Phacilitate

An Interview with Emmanuel Casasola, Executive Director, Global Quality & Compliance, BioBridge Global

Although the advanced therapies industry is not new, no harmonised testing standards are currently available to align the industry. Some groups are actively working on building these standards and government agencies see the need to establish regulations to ensure patient safety; it is only a matter of time before standards are implemented.

Navigating the regulatory framework for biologics allows the testing strategies to be risk-based and phase-appropriate, which can help bridge the needs from research to cGMP compliance. It is exciting to support the industry with our expertise and new testing methods and this also fits well within our mission to save and enhance lives through the healing power of cells and tissue.

The testing question

Questions around required testing are asked frequently by our partners. What to test for? What is needed? How much testing is too much testing? All are very good questions and we aim to offer simple answers to the complex testing conundrum. One of the first things that need to be established is intended use: what is the therapy designed to do and how will it do it? This will facilitate the answers to some questions while also helping to identify key quality attributes.

Testing can typically be broken down into three categories: safety, purity and potency. First and foremost, the safety of the therapy is necessary. From the infectious disease testing of a donor to the final release testing of the product, all the assays need to be qualified. There are USP and EU Pharmacopeia methods that outline sterility, mycoplasma and endotoxin, which are commonly required tests, and these compendial methods are accepted by regulatory bodies. To ensure the methods are appropriate, the sample material should be qualified in a suitability study which would help identify any interfering substances that may give a questionable result. Even for a phase I clinical study, validating the suitability of safety assays is necessary to meet regulatory scrutiny.

The lack of standard purity and potency assays due to the level of innate complexity can be difficult to prove. A combination of a defined Analytical Target Profile (ATP) and the mechanism of action would establish the testing strategy required to ultimately lead to qualification of a therapy.

The USP supplement to <1224> “Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification” states:

“The ATP defines the objective of the test and quality requirements, including the expected level of confidence, for the reportable result that allows the correct conclusion to be drawn regarding the attributes of the material that is being measured. It is essential to reach a high degree of confidence that an analytical procedure will consistently generate reportable results that meet the ATP requirements under all condition of use and as the material progresses through the lifecycle.”

For example, if you are looking for a specific type of cell or exosome, your assay will need to identify those within a certain level of confidence in order to support the findings of a clinical study. A further example from the USP <1224> supplement:

“Assay: The procedure must be able to quantify [analyte] in [presence of X, Y, Z] over a range of A% to B% of the nominal concentration with an accuracy and uncertainty so that the reportable result falls within + C% of the true value with at least 90% probability determined with 95% confidence”

This example states you need to have an assay that can detect a specific characteristic (analyte) within a material (therapy) within a certain level of confidence (95%) with a high degree of repeatability (90%).

Based on whether the therapy is autologous or allogeneic, the purity assay for the donor or starting material is crucial in the manufacturing of the downstream product and the overall logistics. We need to fully understand how viable the cells are, i.e. what’s the time frame from donation to manufacturing to delivery to the patient? This turnaround can be very short and with very complex logistics, as such, testing speed is crucial and a discussion around what type of testing should be implemented is vital to generate results as quickly as possible and ensure the treatment reaches the patient on time? A laboratory partner needs to be nimble enough to provide such services and with unequivocal data.

Navigating regional regulatory requirements

Understanding all the critical quality attributes (CQAs) is essential and will need to be defined in the chemistry, manufacturing and control (CMC) document that is submitted to a regulatory body as a therapy progresses through clinical development to commercialisation. The ability to justify the assays used and how that information helps in determining the efficacy of a therapy will aid in the regulatory approval of your product.

While all regulatory bodies strive for the protection of patients and ensure the safety of the products being marketed within their country’s borders, there are some small nuances between them. Those nuances tend to relate back to the host countries, such as epidemiological and cultural differences.

For this reason, the PMDA (Japan) may have donor requirements that are a little different than the FDA or the EU. The EU is comprised of many nations and depending on where the clinical trial will be conducted will also need to engage with that host country’s agency. Likewise, each region may require different documentation at various phases so it will be critical to ensure all documentation requirements are fully understood.

QualTex Laboratories is available to help

Ultimately, while QualTex Laboratories has recently launched these new services, the experience and expertise are evident by our history of supporting companies. The collaborative spirit and mission-based mentality drives our employees to help deliver new therapies to patients. They are ready to take some of the pressure and questions which may overwhelm an organisation and test samples with high quality and reliable fashion.

COVID study in UK shows high levels of antibodies up to six months after infection

Results could have implications for immunity

Virtually everyone in a study in the United Kingdom who had COVID-19 still had antibodies to it in their systems three months after recovering, and almost nine in 10 had them after six months.

The research by UK Biobank included more than 20,000 people across the UK and was reported on the organization’s website.

“Although we cannot be certain how this relates to immunity, the results suggest that people may be protected against subsequent infection for at least six months following natural infection and, potentially, vaccination,” said Naomi Allen, UK Biobank Chief Scientist.

Six-month study

The study ran from May-December. A total of 20,200 participants provided monthly blood samples and data on their symptoms, along with reports on their adult children and grandchildren.

The most notable result was that 99% of participants who had COVID-19 still had antibodies in their systems after three months, and 88% had them after six months.

Younger people showed more antibodies

The study also found that while there was no difference in antibody levels by gender, the proportion of participants with detectable antibodies was higher in people under 30 and lowest in those over 70.

Variations in symptoms

The most common symptom was a loss of sense of taste and smell, reported by 43% of COVID-positive participants.

Twenty-four percent of COVID-positive participants were completely asymptomatic and 40% did not have one of the three major COVID-19 symptoms: fever, persistent dry cough or loss of sense of taste or smell.

The full report on the study is available on the BioBank UK website.

Recovered from COVID-19?

If you’ve recovered from COVID-19, you can help current South Texas patients fight by donating convalescent plasma. See if you qualify to donate plasma at SouthTexasBlood.org/COVID19.

If you can’t donate plasma, you can help by donating blood to help fight the blood shortage caused by the pandemic.

Testing Strategies and Custom Assay Development for Cell and Cell-based Therapies

Written Jan. 6, 2021 by Michael Adeniya, Event Director, Phacilitate

An Interview with Ward Carter, Chief Operating Officer, QualTex Laboratories

As the cell therapy industry grows and matures, demand for testing has soared. Is testing a bottleneck in getting therapies to market?

It can be, for several reasons. The number of cell therapy development programs has increased dramatically in recent years, and as they progress toward commercialization, demand for testing has grown exponentially. At the same time, only a few laboratories provide testing services for these types of therapeutics.
 
Increasing capacity and obtaining the required global accreditations takes time and considerable effort, which many organizations are not willing to do, or it doesn’t fit with their growth plans.
 
Just to give you an example, the Alliance for Regenerative Medicine reported that between 2015 and 2020, the number of regenerative medicine companies grew from 672 to 1,001, and the number of clinical trials went from 631 to 1,078. All this growth means there is a critical need for more testing to ensure safety and performance of these potential new therapies.

Fully automated testing laboratory

How does testing fit in the overall development and commercialization of cell therapies?

Every therapeutic development process begins with qualification of donor material. Depending on the nature of the product, whether it’s a 1:1 product (autologous or allogeneic) or 1:many (allogeneic), the number and complexity of needed tests changes. It’s important to understand that range up front.
 
Recent feedback from the FDA has highlighted the impact of Critical Quality Attributes (CQAs). Therapeutic developers need to understand their target indication and identify or develop a clear set of potency assays or functional assays early on to support their regulatory approval. The FDA’s recent position regarding a therapy showing clinical benefit, but with insufficient CQAs, makes it clear that moving forward without this understanding is risky.
 
Researchers also need to make sure a testing laboratory has a process for tech transfer of assays if required, at the pre-clinical, clinical and commercial phases.
 
In the case of autologous therapies, turnaround times are tight, so there isn’t much available for backup samples. And while tests tend to focus more on whether the cell manipulation worked, the key is making sure the sample passes more standard donor safety requirements. This is especially true in the case of infectious diseases.
 
And how does testing fit in the overall supply chain?
 
Testing is an integral part of every step of therapeutic development, and it takes a full-service laboratory with a robust infrastructure to handle receiving and tracking a wide range of sample types. That laboratory also needs to be able to develop custom assays.
 
In addition, reporting requirements for cell therapies can vary, and the timing of those reports can affect production. It’s critical to the process that testing providers and therapeutic developers stay in regular communications about needs and results.
 
Given the complexity of the supply chain and the number of stakeholders, it is really important for therapeutic developers to be working with their testing laboratory in tandem with all other partners to establish their testing program, including custom assays.
 
At what point should biotech organizations be looking at custom assay development?
 
If they want to be successful, they need to focus on custom assays early in the process. There are Critical Quality Attributes that are essential for approvals throughout the development process, and standard characterization assays often are not going to be sufficient. Critical 
 
Because there are no established standards for potency, it’s essential that researchers define their own standards that may require multiple assays using different platforms. There also are going to be different assays for different time points through the development process. They could start with functional assays – characterization and possibly potency – in animal models, and then look at other assays at different times, for safety, potency and/or characterization.
 
There are safety assays that will be required before a clinical trial can get underway. Others will need to be converted from in-vivo models into those that can be used in clinical phases of trials.
 
As a testing partner, we offer both research grade and GxP assays. Biotech companies will need both options, based on where they are in the process of developing and commercializing their product – from qualification to quality control and release testing.

QualTex and BioBridge Global headquarters in San Antonio, Texas

Can you tell us more about BioBridge Global’s journey into cell therapy testing?
 
BioBridge Global began as a community blood bank in 1974, and in the last 45-plus years, the number and complexity of tests required by the FDA has grown dramatically. We have been performing those tests in-house for many years. Gradually we expanded into testing donations from other blood centers, and then to other types of donor screening, including plasma and human tissue, as well as custom assay development. Our footprint has become global, with accreditations in the United States, Canada, the European Union, Asia and Australia.
 
In 2016, BioBridge Global was awarded an MTEC contract to develop manufacturing capabilities for cellular products, as well as stand-up capabilities for cell therapy testing. At that time, we decided to invest in a biomanufacturing facility and in the testing required for it. We’re continuing to build a portfolio of cellular therapy assays to support therapeutic developers in their clinical and commercial efforts.

QualTex Laboratories adds Ortho Diagnostics VITROS® Anti-SARS-CoV-2 IgG assay

Test detects antibodies developed during a COVID-19 infection 

QualTex Laboratories, a subsidiary of San Antonio-based nonprofit BioBridge Global, has begun offering the Ortho Diagnostics VITROS® Anti-SARS-CoV-2 IgG assay for use in detecting COVID-19 antibodies. 

The assay helps health care professionals determine if a person’s immune system has developed antibodies to the virus that causes COVID-19. It was approved for Emergency Use Authorization for qualifying COVID convalescent plasma (CCP) by the Food and Drug Administration on Aug. 23. 

Given the recent increase in COVID-19 cases and hospitalizations, the addition of the assay is a timely addition in the battle against the pandemic. 

The FDA has issued an EUA for COVID convalescent plasma, which is donated by those who have recovered from COVID-19, for use in patients with active COVID-19 infections. 

The Ortho IgG test has demonstrated 100% specificity and is currently the only assay approved by the FDA for COVID convalescent plasma qualification. The test runs on Ortho’s high-throughput, fully automated analyzers, and it measures IgG antibodies to the SARS-CoV-2 virus. 

COVID Convalescent plasma is currently being used to save the lives of those most severely affected by COVID-19. This assay provides a powerful tool to identify those blood donors with the highest antibody concentrations to aid in COVID-19 treatment.

QualTex Launches Cellular Therapy Testing Services

Lab to support researchers developing new treatments for global healthcare market

QualTex Laboratories, a subsidiary of San Antonio-based nonprofit BioBridge Global, has expanded its offerings to include cellular therapy testing services in support of advanced therapeutics clinical developers.

The new service provides a full range of research use only (RUO), current good manufacturing practices (cGMP), and good laboratory practices (GLP) qualified assays to support a variety of cellular therapy industry testing needs.

The cellular therapy testing service will allow QualTex to collaborate with clients to get their products to market, while at the same time adhering to the strictest quality standards. Through these collaborations, QualTex will work to develop new assays for the next generation of lifesaving treatments. 

“Every client and every project is unique. Our team’s goals are simple – be nimble enough to meet the needs of clients and at the same time follow the quality practices that are at the core of our organization,” said Ward Carter, Chief Operating Officer of QualTex Laboratories.

The laboratory can expand cell samples and either perform testing in-house or work with partner laboratories to provide a certificate of analysis, as well as individual test reports. 

This new QualTex service offering includes: 

  • Analytical assay development
  • Cell line characterization
  • Expandability and potency testing 
  • Lot and final release assays 
  • Stability testing 

“We have quality processes in place allowing us to provide phase-appropriate and risk-based testing solutions assuring the safety, purity, and potency of cell-based products,” Carter said.

Martin Landon, Chief Executive Officer of BioBridge Global, added “The launch of our cellular testing services provides another expansion to our end-to-end capabilities supporting regenerative and personalized medicine here in San Antonio and across the globe.”

GenCure joins with Sentien Biotechnologies, Rooster Bio on $2.4 million contract

Partners will develop potency assay for mesenchymal stromal cells

The federal Medical Technology Enterprise Consortium (MTEC) has identified the need for potency testing as critical to new cellular therapies.

Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, has been awarded a $2.4 million contract from MTEC.

GenCure and RoosterBio, which is a developer of MSCs and bioprocess media, are partners with Sentien Biotechnologies in the contract.

Together, this team will develop a potency assay framework using MSCs, spanning large-scale biomanufacturing, in vitro assay development and in vivo biomarker analytics. 

The award was granted by the U.S. Army Medical Research & Development Command (USAMRDC) in collaboration with the Medical Technology Enterprise Consortium (MTEC), a 501(c)(3) biomedical technology consortium working in partnership with the Department of Defense (DoD). 

The Defense Health Agency has identified a need for quality management in the biomanufacturing of regenerative medicine-based products. For cell therapy products, the potency assay is the most robust quality metric, representing the biological ability of a product to effect a clinical outcome. Developing a potency assay is a complex challenge, requiring significant characterization of process parameters and quality attributes throughout the preclinical and clinical development stages. 

This work will take an integrated, cross-functional approach to potency assay development. First, biomanufacturing process parameters and quality attributes will be evaluated during the expansion of MSCs derived from different tissue sources. Second, the resulting cell banks 

will be analyzed using Sentien’s ex-vivo bioreactor platform to assess the immunomodulatory effects of the MSCs and generate putative potency markers. Finally, the putative potency markers will be matched against clinical trial samples from subjects with systemic inflammatory conditions who have been treated with SBI-101, Sentien’s lead product. 

SBI-101 is a combination biologic product, in which MSCs reside on the exterior of hollow fibers, while blood flows through the interior. The unique design of SBI-101 enables real-time sampling of both MSC-secreted factors (pharmacokinetics) and their effect on patient blood (pharmacodynamics), which will provide particular value for this project. The ultimate goal of the project is to develop a broadly applicable potency assay framework that members of the regenerative medicine community can leverage for their particular biomanufacturing process, product and indication of interest. 

“Sentien is grateful to MTEC and the DoD for recognizing the potential impact of our proposal and awarding the funds to undertake this work. We have an opportunity to add real value to the regenerative medicine community by developing this potency assay framework which spans R&D, biomanufacturing and clinical translation,” said Chris Gemmiti, Senior Vice President of Operations at Sentien. “This award demonstrates external recognition of how our proprietary microreactor platform can offer unique insights into MSC biology. This is very timely as the interest in MSCs has been increasingly heightened in the context of COVID-19 trials,” said Rita Bárcia, Vice President of R&D at Sentien. “We are very excited to be partnering with RoosterBio and GenCure on this project,” added Sentien CEO, Brian Miller. “We believe this team of collaborators, with complementary technologies and skills, will together produce a valuable, widely applicable deliverable.” 

“We are very much looking forward to this collaboration to provide our platform solutions and expertise in MSC manufacturing in support of this project,” said RoosterBio CEO, Margot Connor. “The development of a MSC potency assay framework is really the cornerstone of a successful regenerative medicine product thus we are grateful for the opportunity to contribute to this team effort.” 

Becky Cap, Chief Operating Officer for GenCure, a subsidiary of BioBridge Global, commented, “GenCure values creative approaches to solving difficult problems, and the Sentien team has developed some highly innovative approaches to treatment with SBI-101. With this project, they are finding ways to leverage that innovation to address more fundamental questions about potency and the impact of tissue source on both potency and therapeutic benefit. We are honored to be part of this project.” 

“Laboratory in a box”: Community Labs rapidly ramps up COVID-19 testing

Community Labs soon will be performing up to 10,000 COVID-19 tests a day and expects to reach capacity of 20,000 or more per day by January, BioBridge Global executives told members of The Blood & Tissue Center Foundation board of directors on Monday.

The organization, which is a nonprofit partnership among local charitable foundations and BioBridge Global, is expanding its community reach for its highly accurate test for COVID-19.

“The real focus is to get schools up and running,” said Richey Wyatt, General Counsel and Chief Compliance Officer at BioBridge Global, who noted that this week, testing was being expanded to seven school districts, mainly on the South Side.

Testing also is projected to start soon for the 300 employees of the state’s Child Protective Services in San Antonio, as well as Trinity University.

“When we started with Somerset ISD, we were doing 500 tests a week, and that ramped up to 500 tests a day,” Wyatt said. “We should have the capacity to be able to perform 10,000 tests per day within a couple of weeks.

“I’d say probably by January, we should be able to double that capacity to 20,000 to 24,000 tests a day.”

Community Labs, which is just the second high through-put “PCR” COVID-19 testing laboratory of its kind in the United States, is beginning to attract outside attention, with interest from officials in the hard-hit El Paso area, as well as Louisiana, Idaho and Georgia, Wyatt said.

All the technology and procedures the lab is using will be made available to anyone who asks, said Dr. Rachel Beddard, Chief Medical Officer at BioBridge Global.

“They’re calling it ‘laboratory in a box’” she said. “They are putting all the information together for any city that might want to do this.”

Community Labs is using the highly accurate PCR test, Dr. Beddard said, checking for three different genetic sequences from the coronavirus that causes COVID-19.

“Some PCR tests look for just one or two, but this one looks for three,” she said. “It’s one of the most sensitive tests out there.”

The tests are designed to identify the so-called “silent spreaders” of COVID-19, individuals who do not have any of the common symptoms. The goal is to make testing much more economically feasible, at just $35 a test vs. $150, and provide a turnaround time of less than 24 hours, to help stop the spread of the virus.

More information about Community Labs is available at CommunityLabs.org and on the BioBridge Global website.