VITALiS Selects Applied BioCode for Molecular Gastrointestinal Pathogen Panel Testing

VITALiS Expands Collaboration With Applied BioCode to Support In-House Gastrointestinal Pathogen Testing

VITALiS and Applied BioCode have announced an expanded collaboration aimed at increasing the adoption of gastrointestinal (GI) pathogen testing in commercial laboratories and physician office laboratory settings. Under the agreement, VITALiS has selected Applied BioCode as its preferred solution provider for GI pathogen testing and will offer the company’s Gastrointestinal Pathogen Panel (GPP) and BioCode® MDx-3000 System to its existing and prospective customers.

The collaboration brings together VITALiS’s expertise in life sciences products, diagnostic solutions, customer support and laboratory implementation with Applied BioCode’s molecular diagnostic technology. The companies intend to help laboratories transition gastrointestinal pathogen testing into their own facilities, providing an integrated approach that combines diagnostic testing platforms with validation support, infectious disease expertise and information technology solutions.

The expanded relationship builds on the companies’ recent experience working together to support laboratories seeking to bring GI pathogen testing in-house. By extending access to the Applied BioCode platform through VITALiS’s established customer network, the collaboration is intended to make molecular diagnostic solutions more accessible to commercial laboratories and physician office laboratories across the United States.

The announcement also reflects the growing importance of laboratory workflow flexibility, operational efficiency and access to molecular diagnostic technologies in infectious disease testing. For healthcare providers and laboratories, the ability to conduct testing within their own facilities can offer greater control over diagnostic workflows and the management of testing services, depending on laboratory capabilities, test requirements and implementation needs.

Marcus A. Cognetti, President and Managing Director of VITALiS, said the company had selected Applied BioCode as its preferred vendor for GI pathogen testing following recent experience supporting the implementation of testing at a large gastrointestinal group practice. The companies also intend to explore additional product opportunities as their collaboration develops.

VITALiS Selects Applied BioCode as Its Preferred GI Testing Partner

VITALiS provides life sciences products and diagnostic solutions, with a focus on the design, sourcing and distribution of products for the polymerase chain reaction (PCR) testing market. Through its work with laboratories and healthcare providers, the company supports the adoption and implementation of diagnostic technologies used in clinical testing environments.

As part of the expanded collaboration, VITALiS will offer Applied BioCode’s Gastrointestinal Pathogen Panel and BioCode MDx-3000 System to its current and future customer base. The selection establishes Applied BioCode as VITALiS’s preferred solution provider for gastrointestinal pathogen testing.

The arrangement is designed to combine product access with the practical support laboratories may require when introducing a molecular diagnostic platform. Implementing a new testing system can involve instrument deployment, assay validation, workflow planning, laboratory personnel training and integration with existing information technology infrastructure. These activities are important in helping laboratories establish testing processes that meet their operational and quality requirements.

VITALiS brings customer relationships and experience supporting laboratories through these implementation steps. Its validation support, infectious disease expertise and integrated IT solutions are intended to complement Applied BioCode’s diagnostic platform, creating a more coordinated pathway for laboratories seeking to perform GI pathogen testing in-house.

For Applied BioCode, the partnership provides a route to reach additional laboratories through a company with established relationships in the PCR testing market. For VITALiS, the agreement expands its diagnostic offering with a molecular testing panel and instrument system specifically intended for gastrointestinal pathogen testing.

The companies expect the collaboration to support commercial laboratory environments as well as physician office laboratories. These settings can have different operational requirements, staffing structures and testing volumes, making access to appropriate diagnostic technologies and implementation support an important consideration.

The announcement does not specify the number of laboratories expected to adopt the system, a commercial rollout schedule or the financial terms of the agreement. However, the expanded collaboration establishes a framework for VITALiS to promote and support the Applied BioCode GPP and MDx-3000 System among its customers.

Applied BioCode GPP and MDx-3000 System Form the Core Offering

The central components of the collaboration are Applied BioCode’s Gastrointestinal Pathogen Panel and BioCode MDx-3000 System. Together, the panel and instrument platform are intended to support molecular testing for gastrointestinal pathogens.

Gastrointestinal infections can be caused by a range of infectious agents and may produce symptoms such as diarrhea, abdominal discomfort, nausea and vomiting. Identifying the pathogen responsible for an infection can help healthcare professionals make more informed decisions about patient management and appropriate treatment, where indicated.

Molecular diagnostic methods, including PCR-based approaches, are widely used in infectious disease testing because they can detect genetic material associated with target pathogens. Depending on the assay, such tests can help laboratories identify multiple infectious targets through a defined testing workflow.

A gastrointestinal pathogen panel is designed to evaluate specimens for a specified set of infectious targets. The panel’s particular target coverage, performance characteristics and intended use are important factors when laboratories assess whether it meets their clinical and operational needs.

Applied BioCode’s GPP and MDx-3000 System will be offered through VITALiS as part of the companies’ strategy to support laboratories bringing GI pathogen testing into their own testing environments. The collaboration combines the diagnostic products with VITALiS’s customer-facing support and implementation capabilities.

The announcement does not detail the panel’s full pathogen list, turnaround time, analytical performance characteristics or regulatory status. Laboratories considering adoption will need to review the applicable product documentation, intended-use information and validation requirements to determine suitability for their particular setting.

The availability of a diagnostic platform is only one part of establishing an in-house testing service. Laboratories must also consider specimen handling, quality control, workflow capacity, staff competency, data reporting and integration with laboratory information systems. The collaboration is intended to address these broader implementation considerations by bringing together Applied BioCode’s technology and VITALiS’s support capabilities.

Supporting the Transition to In-House GI Pathogen Testing

A key objective of the expanded collaboration is to help laboratories transition gastrointestinal pathogen testing from external service arrangements or other existing workflows into their own facilities, where appropriate.

In-house testing can provide laboratories with greater direct control over their diagnostic processes. Depending on the laboratory’s existing infrastructure and testing needs, it may also help simplify coordination between specimen receipt, testing, result review and reporting.

However, establishing an in-house molecular testing capability requires planning. Laboratories must determine whether they have the necessary equipment, personnel, space, quality systems and information technology resources to operate the testing service. They may also need to validate the relevant testing process before introducing it into routine use, in accordance with applicable requirements.

VITALiS’s experience in validation support and integrated IT solutions is intended to help customers navigate these practical considerations. Its infectious disease expertise and established relationships with laboratories provide an additional layer of support as customers evaluate and implement diagnostic products.

Applied BioCode contributes its molecular diagnostic platform, including the GPP and MDx-3000 System. By combining these capabilities, the companies aim to provide an integrated offering that supports laboratories beyond the initial purchase of diagnostic equipment or assays.

Their previous work together provides the foundation for the expanded arrangement. According to VITALiS, the companies have recently supported gastrointestinal pathogen testing at one of the largest GI group practices. This experience contributed to VITALiS’s decision to select Applied BioCode as its preferred vendor for GI pathogen testing.

The companies have not disclosed further details about the specific laboratory implementation, the scale of testing or the results of the deployment. Nevertheless, the experience illustrates the practical basis for extending the collaboration to additional customers.

VITALiS Emphasizes Customer Support and Future Product Opportunities

Marcus A. Cognetti, President and Managing Director of VITALiS, highlighted the company’s recent experience supporting gastrointestinal pathogen testing and its decision to expand the relationship with Applied BioCode.

“With recent success supporting gastrointestinal pathogen testing at one of the largest GI group practices, VITALiS has selected Applied BioCode as our vendor of choice for GI pathogen testing and will be offering Applied BioCode’s GPP panel and MDx-3000 System to our current and future customer base,” Cognetti said.

He added: “We’re excited to offer the Applied BioCode’s GPP panel and MDx-3000 System to our current and future customer base and to collaborate with Applied BioCode on additional product opportunities in the future.”

Cognetti’s comments underscore two priorities for VITALiS: expanding access to the Applied BioCode diagnostic platform and exploring additional opportunities with the company over time.

The initial focus is on gastrointestinal pathogen testing, but the companies have indicated that they intend to consider further product opportunities. No additional products or specific development plans were identified in the announcement.

The potential for further collaboration may allow the companies to build on their existing relationship and evaluate other molecular diagnostic solutions that could meet customer needs. Any future opportunities will depend on the products involved, market requirements and the companies’ subsequent decisions.

For VITALiS, the expanded relationship also strengthens its portfolio of offerings for laboratories operating in the PCR testing market. By providing access to a dedicated GI pathogen testing solution, the company aims to support customers looking to develop or expand their molecular diagnostic capabilities.

Applied BioCode Sees Opportunity to Expand Laboratory Access

Applied BioCode welcomed the expanded relationship and emphasized VITALiS’s understanding of the clinical laboratory market and its ability to support customers throughout the implementation process.

Dr. Parisa Hanachi, Vice President of Marketing at Applied BioCode, said the collaboration would support efforts to bring gastrointestinal pathogen molecular testing into commercial laboratory environments.

“We are pleased to partner with VITALiS and support its efforts to bring gastrointestinal pathogen molecular testing into commercial laboratory environments,” Hanachi said. “VITALiS demonstrates a strong commitment to bringing accessible molecular diagnostic solutions to healthcare providers and laboratories. We value VITALiS’s understanding of the clinical laboratory market and its ability to work closely with customers throughout the implementation process. We look forward to expanding this collaboration and exploring additional opportunities to bring molecular diagnostic testing solutions to laboratories across the United States.”

Hanachi’s remarks highlight the importance of customer support in the adoption of diagnostic technologies. Even when a molecular testing platform is available, laboratories must determine how it fits into their existing processes and what resources are required to implement it effectively.

A partner familiar with laboratory operations can help customers assess those needs and coordinate implementation activities. VITALiS’s customer relationships and support services are expected to complement Applied BioCode’s diagnostic technology as the companies work to expand access to the GPP and MDx-3000 System.

Applied BioCode’s stated objective is to broaden the availability of molecular diagnostic solutions across laboratory environments in the United States. The expanded collaboration with VITALiS provides a channel for pursuing that objective in gastrointestinal pathogen testing.

Molecular Diagnostics Remain Important in Infectious Disease Management

The partnership comes within a diagnostic landscape in which molecular testing plays an important role in identifying infectious agents and supporting clinical decision-making. Gastrointestinal infections can have overlapping symptoms, making laboratory testing useful when a clinician needs to determine the likely cause of illness.

A molecular panel can assess a specimen for multiple specified targets within a single testing workflow, depending on the panel design. This can help laboratories evaluate a range of potential infectious causes without relying exclusively on separate tests for individual pathogens.

The practical value of such testing depends on several factors, including the pathogens covered by the assay, the patient population, the specimen type, the clinical context and the laboratory’s ability to perform and interpret the test appropriately.

For laboratories considering in-house GI pathogen testing, the choice of platform must also account for workflow compatibility, quality assurance, reporting processes and available resources. The expanded VITALiS–Applied BioCode collaboration is designed to bring these considerations together with access to a molecular diagnostic panel and instrument system.

By pairing diagnostic technology with validation support, infectious disease expertise and integrated IT solutions, the companies aim to help laboratories establish testing workflows suited to their own environments.

Expanded Collaboration Supports Commercialization and Growth

The agreement between VITALiS and Applied BioCode strengthens their shared focus on making molecular diagnostic testing more accessible to commercial laboratories and physician office laboratories. VITALiS will offer the Applied BioCode Gastrointestinal Pathogen Panel and BioCode MDx-3000 System to its existing and prospective customers, supported by its experience in laboratory implementation and diagnostic product distribution.

The arrangement builds on recent experience supporting GI pathogen testing at a large gastrointestinal group practice and establishes Applied BioCode as VITALiS’s preferred solution provider in this area. It also creates a foundation for the companies to explore additional product opportunities in the future.

For VITALiS, the collaboration expands its diagnostic offering and reinforces its role in supporting laboratories adopting PCR-based testing solutions. For Applied BioCode, it provides an opportunity to reach a broader customer base through a partner with established laboratory relationships and implementation expertise.

The companies have not announced specific commercial milestones, projected adoption figures or a timeline for broader rollout. Their stated objective is to support laboratories seeking to bring gastrointestinal pathogen testing in-house by combining diagnostic products with the expertise and services needed for implementation.

As the collaboration develops, VITALiS and Applied BioCode intend to build on their complementary capabilities to support molecular diagnostic testing across laboratory environments in the United States. The expanded agreement represents a step toward that goal, with gastrointestinal pathogen testing serving as the initial focus and potential additional product opportunities remaining part of the companies’ longer-term collaboration strategy.

About VITALiS

VITALiS Health, Inc. is a New Jersey-based provider of innovative life sciences products and diagnostic solutions, specializing in the design, sourcing, and distribution of products for the healthcare market. The company designs and provides products and services for PCR products and reagents used in infectious disease testing, including urinary tract infections (UTIs), sexually transmitted infections (STIs), bacterial vaginosis (BV), and respiratory infections and will be launching new, innovative products later in 2026 and early 2027. VITALiS offers PCR primers and probes, consumables, PCR validation and analysis software, and has recently expanded into the distribution of specimen collection kits and collection media.

About Applied BioCode

Applied BioCode, Inc. is an in vitro diagnostics manufacturer focused on developing and commercializing multiplex molecular diagnostic solutions for infectious diseases. The company’s BioCode® platform uses barcoded magnetic bead technology and automated molecular diagnostic workflows to support mid to high-throughput testing. The company’s portfolio includes FDA-cleared gastrointestinal and respiratory pathogen panels for use with the BioCode® MDx-3000 System.

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