True Diagnostics, Inc. (TrueDx), a leading Point of Care (POC) company, Infectolab Americas (Infectolab), a recently established CLIA laboratory specializing in comprehensive testing for tick-born infection, and Veravas, Inc. (Veravas), an emerging diagnostic company focusing on proprietary sample preparation products and new diagnostic tests, announced today their Strategic Alliance to develop and commercialize VeraTest™ SARS-CoV-2 IgA/IgG Rapid Test. This novel POC test will utilize the TrueDX Platform™, Infectolab's COVID-19 serology testing services and infectious disease expertise,and Veravas' patent pending VeraPrep™ clean and VeraPrep™ capture technologies to remove cross-reacting antibodies to other coronaviruses while only binding and detecting antibodies specific to SARS-CoV-2. Serology testing makes population screening possible, including screening of people who were never diagnosed, either because they didn't feel particularly sick or they couldn't get an initial test. VeraTest™ SARS-CoV-2 IgA/IgG Rapid Test will play an important roll in understanding COVID-19 and the epidemiology of this coronavirus.
VeraTest™ SARS-CoV-2 IgA/IgG Rapid Test will provide a digital qualitative answer in less than 15 minutes to determine if antibodies against COVID-19 have been detected in the blood. IgM and IgA provide the first line of defense during viral infections, followed by the generation of adaptive, high-affinity IgG responses for long-term immunity and immunological memory. The detection of COVID-19 IgA antibodies tends to indicate a recent exposure to COVID-19 and is more specific for COVID-19 in lung tissues and mucosal surfaces, and detection of COVID-19 IgG antibodies indicates a later stage of infection, so this combined antibody test could also provide information on the stage of the disease in patients. Current guidance from the U.S. Food and Drug Administration (FDA) recommends that results from antibody testing should not be used as the sole basis to diagnose or exclude coronavirus infection. Depending on the clinical scenario, additional testing, such as with VeraTest™ COVID-19 IgA/IgG Rapid Test, may be considered to further evaluate the possibility of SARS-CoV-2 infection.
"In these challenging times, True Diagnostics, Inc. is proud to be part of this alliance to help expedite critical solutions that can help provide the needed specificity, performance, scalability, and simplicity to market," stated Jerry Lee, CEO and President of True Diagnostics. "Veravas is quickly emerging as the leader in raising the standard of care in laboratory medicine and we look forward to co-developing tools that are essential to support the IVD market and improving the lives of so many patients."
"A collaboration between Infectolab Americas and Veravas is the logical consequence for our two Minnesota companies. We are complementary to each other and have a lot of synergy. We will use this to achieve something that is desperately needed in this time of testing crisis. We will strive to deliver a high quality test for SARS-CoV-2 that is more accurate and sensitive than any other test on the market," said Felix Scholz, President of Infectolab Americas.
"This strategic alliance with TrueDx utilizing their TrueDX Platform™, along with Infectolab's CLIA lab validation capabilities and infectious disease expertise, will allow Veravas to quickly develop a POC test that's easy to use and displays results in under 15 minutes. We are confident that the combined efforts of our three companies will result in the successful development of a rapid test that will assist healthcare providers and laboratorians to quickly and reliably determine whether a patient has developed antibodies to the COVID-19 virus. Most importantly, it will identify those individuals who can safely return to work and go about their daily lives," said Carroll E. Streetman Jr., Chief Executive Officer of Veravas.
TrueDx and Veravas continue to collaborate and expand their portfolios with other emerging organizations and institutions to bring diagnostic solutions and products like VeraTest™ to market.
About True Diagnostics
True Diagnostics (TrueDx) designs and develops innovative POC diagnostic tests and devices based on its proprietary TrueDX™ Platform, which utilizes reliable and low-cost lab methods and its own proprietary or partnered biomarkers to offer rapid diagnoses to facilitate treatment decisions in point-of-care, point-of-incidence and remote-of-care settings. The TrueDX Platform's portability and affordability allow it to be easily adopted into emerging markets to provide accurate diagnosis within minutes. For the $21 billion point-of-care market, the power of the TrueDX Platform lies in its simplicity and flexibility. Tests have an 18-month or longer shelf life with no refrigeration required. The platform's flexible design additionally permits it to quickly commercialize a myriad of biomarkers discovered for cancer, autism, Alzheimer's, diabetes, drugs of abuse, infectious diseases, cardiac health, traumatic brain injury, viral and bacterial infections and more.
About Infectolab Americas
Infectolab Americas is a recently established laboratory located in Oakdale, Minnesota, specializing in comprehensive lab testing for tick-borne infections which provides the tools necessary for Health Care Practitioners to diagnose tick-borne diseases. Their focus is on delivering a quality laboratory performance and guaranteeing a superior sample output; this entails quick shipping time and a rapid turnaround time, as well as providing the most accurate laboratory results possible.
Veravas is transforming laboratory medicine with technology that delivers superior test results, providing confidence to clinicians and patients that diagnoses are accurate. The company's R&D facilities are based in Oakdale, Minnesota, and our staff of scientists and business development are rapidly driving the commercialization of proprietary sample preparation products and new diagnostic tests. Veravas' nanomagnetic particles can identify, remove, and measure select substances from patient samples to reduce the effects of complex interferences and detect low-abundance biomarkers. Led by a passionate and dedicated team, Veravas is devoted to improving patient lives by minimizing the harmful effects of unnecessary treatments and deaths associated with poor quality diagnostic results. Because every patient deserves the correct result, every time. Please visit us at www.veravas.com