As the COVID-19 pandemic winds down, IVD developers should pursue full clearance for their COVID-19 tests if they want to continue to sell them after the emergency declaration ends. To transition from EUA to full clearance, either through 510(k) or de novo pathway, developers need several additional data sets beyond those required for EUA. TE IVD Solutions helps developers plan and execute the additional required studies, and create the submission.

A reader platform typically consists of optical, mechanical, electrical subsystems and software. Assembling these into one cohesive system is a complex process. Initiating a project from a design/concept can cost millions of dollars and take years with a high degree of risk. At DCN Dx we help our clients leverage our pre-developed instrument platforms to shorten, de-risk, and lower the cost of a more traditional development path. 

The pandemic has catapulted virtual care and at-home testing into the forefront of medicine. Many Americans have learned to manage their health virtually, but health cannot be properly managed without the critical datapoint from clinical laboratories. During this session, we will explore the landscape of at-home-testing, which will include both at-home collection of clinical samples to be mailed to clinical laboratories and point-of-care devices resulted in the home.

COVID-19 has resulted in major disruptions in STI services, including diagnostic testing. Many public health clinics closed or severely curtailed in-person visits in lieu of telemedicine. The lack of walk-in services likely led to under-ascertainment of STIs. During that period,  self-collected mail-in specimen laboratory-based testing has increased dramatically for both STIs and COVID-19. Over-the-counter diagnostic testing for COVID-19 will also be discussed and its implications for future STI OTC testing.

The SARS-CoV-2 pandemic impacted healthcare delivery systems and accelerated alternative delivery strategies. Remote specimen collection with samples sent to a central laboratory as well as at home testing options have shifted the paradigm in the patient journey. The goal of this talk is explore how clinical laboratories are pivoting to meet the needs of alternative delivery strategies for testing and the impact on the central laboratory. This talk will explore the position of the clinical laboratory in the healthcare ecosystem, the impact of SAR-CoV-2 testing on diagnostic delivery strategies, the future of remote specimen collection and at home testing and the role of the clinical laboratory with alternative delivery strategies.

The COVID-19 pandemic has undeniably accelerated the acceptance of self-diagnostic programs across the industry and influenced more patients to take ownership over their healthcare. In this session, we will examine the role of software in building effective testing programs that can contribute to testing and treatment compliance, expanding access to care, and managing population health outcomes.

COVID-19 testing solutions must provide the right combination of performance, ease of use, and data integration on-site facilities demand. They must be resistant to an ever-changing variant viral landscape. This presentation will address the technology battle providers face today, and present the data to highlight how the use of differentiated Bulk Acoustic Wave detection within the Qorvo Biotechnologies Omnia SARS-CoV-2 Antigen Test enables the future of on-site testing.

Our Co-Dx PCR Home Platform is designed to provide fast, inexpensive, and accurate PCR test results, utilizing proprietary chemistry and instrumentation. See how we are disrupting the status quo with our revolutionary PCR Products.

Novel technologies now enable lab-comparable testing to be performed in point-of-care settings. Learn how implementation of the LumiraDx Platform in an independent community pharmacy contributed to community care in Green Bay, WI. LumiraDx, a next-generation diagnostics company, is transforming community-based healthcare. The LumiraDx Platform combines a small, easy-to-use, and portable instrument with an innovative microfluidic test strip to deliver high-sensitivity rapid antigen testing. 

Health care equity is a cornerstone of healthy communities. Access to diagnostic care is critical to disease management in communities. This presentation will provide overview of a project launched to provide essential diagnostic testing for screening chronic kidney disease in remote communities in Manitoba, Canada, using point-of-care devices. The laboratory services provided meets laboratory quality requirements while allowing for its administration in non-lab setting, thereby ensuring access to care.

The COVID-19 pandemic has accelerated the pace at which point-of-care (POC) testing is being adopted in the community pharmacy setting. Increasing numbers of community pharmacies are interested in developing their POC test and treat programs, including large pharmacy chains, as the US increasingly looks to this setting as a public health destination. After two years of the pandemic, the question is not if community pharmacy will adopt, but how. 

In recent years, point-of-care testing has expanded rapidly. POCT is increasingly performed in a variety of care settings, ranging from hospitals and physicians’ offices to pharmacies, assisted living facilities, and patients' homes. Learn what policy options legislators and regulators are considering as they seek to balance patient access to testing with the need to assure the tests are accurate and useful.

Point-of-care testing (POCT) provides rapid test results with the potential for improved patient care. With the COVID pandemic, traditional POCT options in the hospital and clinics have expanded POCT use into the community with pharmacy testing, visiting nurses, and doctor on-call services providing more personalized patient care. POCT is being conducted at sports, concerts, and other events. At-home self-testing is increasing with reliance on remote doctor visits and telehealth. Patients are purchasing POCT devices at pharmacies, grocery stores, and through the internet. This session will explore the various ways that POCT is being utilized in healthcare. 

The Vera-stat instrument is a novel POC device resulting from the collaboration of Randox Laboratories and Labmaster. With its proprietary cathodic electrochemiluminescence technology, it enables quantitative measurements of single analytes in 5 to 10 minutes, with exquisite accuracy and sensitivity, from a little as 10 µL of whole blood. The current pipeline is focused on infectious diseases, with ambition for development in multiple therapeutic areas and the addition of multiplex capabilities.

In a diagnostics study for infectious disease, it it important to be able to pinpoint geographic hot spots and have the ability to activate local sites in that region to reach optimal patient pools. Learn how the utilization of decentralized sites in these studies allows for quick site pivoting to endemic geographic areas of high infection rates. 

We present an alternative to PCR for the detection and quantification of molecular targets. The method – Detection by Proxy – combines nanotechnology, microfluidics, and semiconductors in a unique way that facilitates molecular detection outside a clinical setting.

eRapid is a multiplexed electrochemical diagnostics platform capable of performing immunoassays, detecting nucleic acids and small molecules in complex fluid samples, including blood, saliva, and urine without sample preparation. Our novel platform based on antifouling nanocomposite coating enables us to multiplex analytes within the same microfluidic channel, achieve up to 100x sensitivity over traditional platforms, and do so at a fraction of the cost of competing platforms. Designed from the ground up with scalable manufacturing in mind, flexibility to pursue a massive range of tests, eRapid is adaptable to a variety of testing strategies addressing high-value diagnostic and detection challenges in multiple fields, ranging from healthcare to industrial, environmental, and food applications. 

The epigenome is the molecular link between the environment and the genome causing different phenotypes to be expressed due to environmental stimuli. By understanding epigenetics, one can identify chemical or biological exposures affecting health. We present a platform for diagnostic target identification to enable rapid development of diagnostic tests for exposure health. These markers are being developed into diagnostic assays to rapidly identify exposures to prevent or treat illness.

The truCOLLECT Whole Blood Collection Kit (Class I Device), is an alternative to phlebotomy for small volume decentralized blood collection.  After collection, whole capillary blood is stabilized by active desiccation allowing shipment and long-term storage at ambient temperature.   An efficient and automatable DNA extraction and purification protocol was developed that yields high quality DNA for NGS and other assays.  Protocols for plasma protein extraction (anti-SARS IgG titer determination) are available.