The COVID-19 Pandemic highlighted the need for rapid in-field diagnostic technology for infectious disease identification. QUASR Diagnostics has developed the next-generation molecular medicine platform to commercialize the next generation of rapid molecular diagnostic tests. With technology developed and licensed from the SANDIA National Laboratories, QUASR assays are a modified version of a PCR-LAMP assay that allows for rapid point-of-care or in-field molecular diagnostics.
Applied InGENuity Diagnostics, a diagnostics company focusing on molecular testing, was looking to expedite COVID testing for customers on the west coast without shipping samples to their laboratory in Florida. To achieve this goal, they started looking for technology that would allow for more rapid diagnostic testing for disease identification and testing that could be done on-site or point-of-care. They identified the QUASAR technology from Sandia National Labs, a New Mexico-based Federal laboratory whose mission is focused on national security.
Dr. Maulik Shah, medical and laboratory director of Applied InGENuity Diagnostics, recognized the value of QUASAR technology as a platform technology that allows for both rapid development of molecular diagnostic assays as well as rapid commercialization as the technology is compatible with existing instrumentation. Dr. Shah contacted Sandia and negotiated a license for the technology. Working with Sandia scientists, QUASR Diagnostics received the Technology Readiness Initiative award to develop QUASR assays for Influenza and RSV. In 2023, QUASR Diagnostics won the Best in Region from the Federal Laboratory Consortium for Technology Transfer for its collaborative research efforts.
QUASR Diagnostics has finished R+D for several assays of interest to the military, government, and public health. These include QUASR assays for Influenza, RSV, West Nile Virus, Chikungunya, and Monkeypox. They are continuing to expand the portfolio of tests to include other market segments, including veterinary and agriculture.
QUASR technology offers several advantages over the current molecular diagnostic methods, including improved sensitivity, ease of use, rapid results, scalability, hardware compatibility, and rapid design and commercialization. As a result of these features, the QUASR assays are the first Quenched LAMP assays for clinical use, offering a platform technology for commercialization across medical fields.
QUASR assays allow target-specific detection based on a dye-labeled primer incorporated into an amplicon, including a short complementary quencher that hybridizes unincorporated primer upon cooling, quenching non-specific fluorescence. They are based on LAMP and RT-LAMP assays, offering rapid design capability and compatibility with complex matrices such as human blood. Loop Isothermal Amplification (LAMP) and Reverse-Transcriptase LAMP (RT-LAMP) were considered the future of PCR identification testing. However, drawbacks include poor discrimination capability, inability to multiplex targets and high rates of false positives. QUASR assays developed at SANDIA National Labs are designed to overcome these limitations.
Initially developed for biothreat detection, QUASR assays allow rapid in-field diagnostic testing for emerging pathogens. Compatibility with existing platforms and robotic liquid handlers allows for deploying high-throughput or in-field use systems. In addition, QUASR Diagnostics has developed a QUASR assay-associated app. Using colorimetric QUASR assays, this app can leverage a mobile device camera for detection, allowing QUASR assays to be developed as at-home test kits. These features make QUASR assays a platform technology capable of being deployed in various settings for various needs and purposes, from direct-to-consumer assays using the app to high-throughput detection of the next pandemic pathogen for governments and public health agencies to in-field or in-office testing for veterinary pathogens or even for agricultural purposes to test for agents potentially destructive to crops. The multi-platform capabilities of QUASR assays position QUASR Diagnostics to be the next molecular medicine solution.
Pathogen assays can be commercialized through FDA approval or a Laboratory Developed Test (LDT) pathway. QUASR Diagnostics teamed with Applied InGENuity Diagnostics to perform all of the method validations using the LDT pathway allowing Applied InGENuity Diagnostics to replace their current COVID-19 and Monkeypox assays with QUASR assays. Through this partnership, QUASR’s technology will be integrated with Applied Ingenuity Diagnostics’ existing diagnostic testing infrastructure, enabling faster commercialization and providing proof of concept and principle while generating data in a CLIA-approved clinical laboratory. QUASR Diagnostics will continue to develop assays where AIDX will be the lead customer to utilize these assays in clinical diagnostics. As AIDX was a lead provider of COVID-19 testing to State governments, Public Health Departments, and other clients, this collaboration will allow QUASR assays to be put into commercial use rapidly. AIDX also provided on-site testing services for convention centers and other agencies, as well as operating a mobile laboratory. As a result, AIDX can now utilize QUASR assays to validate their use for rapid testing for in-field or on-site needs. By providing on-site, point-of-care molecular diagnostics, the partnership aims to enhance the capabilities of government, military, and public health agencies in responding to emerging health threats and protecting public health.
Overall, the QUASR assay system is an innovative platform technology with far-reaching implications. Its ability to rapidly and accurately detect pathogens, its compatibility with existing clinical platforms, and its ease of use make it an attractive option for various applications. As the technology continues to develop, it has the potential to revolutionize the field of molecular diagnostics, bringing accurate and timely testing to more people and places than ever before.
Meet the team
Dr. Maulik Shah is a Chief Executive Officer with extensive experience in gene therapy and genetics. He completed his MD and Ph.D. from the Medical College of Virginia with research in gene therapy at the National Institutes of Health (NIH) in the cancer gene therapy branch. He then trained in internal medicine and clinical genetics at the Baylor College of Medicine and became a faculty member at St. Louis University in St. Louis. Dr. Shah was previously the US Medical Director of Numares AG, a multi-national diagnostics company commercializing assays using novel metabolomics technology. He has extensive experience in diagnostics test commercialization.
In 2018, Dr. Shah partnered with Ravi Bhosale, the CEO of Fidus medical billing services, to create Applied InGENuity Diagnostics. The company’s initial focus was to develop novel diagnostic assays in the arena of pharmacogenomics, which involves analyzing genes that control how patients metabolize drugs, with the goal of developing better clinical decision-making tools for physicians and care providers. However, when the COVID-19 pandemic hit, the company pivoted to provide COVID-19 testing. The company also opened a West Coast branch and licensed the Quasar technology.
Ravi Bhosale is the Chief Operating Officer of Applied InGENuity Diagnostics and QUASR Diagnostics Inc. He is a Production engineer and has an MBA. He is a Global Information Technology & Business Executive with over 32 years of experience developing and executing IT & Business strategies aligning with corporate objectives. In addition, he has a successful track record as a leader & business partner who collaborates with other executives to transform and simplify business processes while delivering bottom-line measurable benefits. He has worked in various industries, including global manufacturing, IT services, consulting, healthcare, and service industries.
Ravi started his career as a production engineer at Cummins in Pune, India. He later moved to the IT department, leading multi-department teams implementing Oracle ERP at various Cummins companies in India. He then worked on Global ERP Implementation projects for GE Healthcare in Tokyo, Japan & Wisconsin, USA. He then worked with Fujitsu America Inc as a senior director managing the PMO office. He then started Fidus Medical Billing Services company and now manages multiple companies.
