Why Molecular Diagnostics
Molecular diagnostics can improve patient care while also lowering health care costs. Molecular tests are essential in helping guide patent treatment and reducing the chance of treatment failure. Because the costs for lab equipment and supplies are rapidly falling, in-house molecular testing is becoming a promising area for growth opportunities for physician-owned laboratories and even major health systems.

 

 

Why Partner with NEXT?
A major barrier to entry into molecular diagnostics remains the human capital and technical expertise needed to effectively design, launch, optimize, and manage innovative molecular diagnostic service offerings.

 

NEXT can provide a clear path to helping you implement a state-of-the-art molecular diagnostic laboratory custom tailored to your organization’s strategic, operational, and financial goals. NEXT will help you identify and implement integrated molecular diagnostic services spanning cutting-edge next generation genomic sequence analysis technologies to the latest in rapid, high-throughput infectious disease testing. NEXT can
help ensure that your molecular service offering is built on the appropriate platform to meet your testing capacity with a workflow that easily integrates with your current operations. From space planning and design to vendor contracting, licensing, validation and billing, NEXT provides a one source solution to your molecular service offering.

 

The NEXT Advantage
NEXT personnel represent more than 200 years’ combined laboratory experience in providing molecular, analytical, and laboratory consultative services. Our technical experts have broad ranging expertise across all life science disciplines and have been pioneers in diagnostic discovery development and commercialization.

 

You Talk -- We Listen, Advise, Plan, Build and Launch
Our Goal is Simple – To help our customers maximize the powers of molecular diagnostics delivered under the highest standards of reliability, patient safety, and cost containment.

 

To get the most out of our services, your first step is to set-up an initial discovery call. Based on our conversation, NEXT will assign and Project Manager and will outline a plan that highlights the overall development of your proposed molecular service offering(s). We will address the proposed operation, its management, and the launch process. Our plan will help you determine whether an in-house lab is practical for your organization (and of course, NEXT’s laboratory services are available to you as an out-source option!).

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Typical Laboratory Operational Models

• NEXT Molecular Lab Model - NEXT provides a turn-key molecular lab, manages all aspects of lab start up with test menu custom reports. NEXT manages platform selection, installation, optimization, assay validation and on-site staff proficiency training. NEXT also manages negotiation of you reagent contracts and human resources essential to your molecular lab. Ongoing XX hours of technical support is also included post launch.

• The NEXT Tech Transfer Model provides organizations the ability train staff, model work flows, and recognize the benefit of services while on-site capabilities are becoming operational. The Tech Transfer Model reduces the mental stress and financial burden of startup. NEXT will validate the testing in our facility as your incubator lab, train staff, and conduct proficiency testing under NEXT’s guidance prior to instillation and in-source validation at the clients’ laboratory.

• NEXT White Label services model - Off-the-shelf or customer designed lab menu invoiced on a fee-for - service of lab-to-lab contract basis, with additional billables for proficiency training and consulting hours.

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Key Components of a NEXT Turn Key Laboratory

 

Service Agreement
NEXT we will prepare a services agreement detailing our services and deliverables. A deposit is required with the agreement. Service agreements are customizable and priced accordingly. NEXT will find the solutions that best suits your needs.

 

Construction & Design
NEXT technical consultants will draft space plans for your future lab. In coordination with local zoning and code officials/architect, we will ensure that the work flow elements are optimized to your business.

 

Laboratory Outfitting
We are not a lab equipment company and therefore are agnostic with regard to assay platforms, equipment, or reagents – our motives are to find the highest quality equipment and reagents for your business needs at the most competitive prices.

 

Staffing/Hiring
As a part of our full-service lab set-up, NEXT will implement staffing services to ensure your laboratory is staffed with the very best individuals for the success of your business. Our efforts will be subordinate to your own HR department, but we can facilitate the hiring process including placing ads, phone interviews, in-person interviews, resume screening, preparing job descriptions, competency evaluations, etc.

 

Training
NEXT is current with the latest training and compliance standards. We ensure your staff completes safety training and is proficient in methodologies and equipment utilized in your molecular lab.

 

Lab Manuals
Keeping you in line with the latest changes in laboratory regulations, NEXT develops complete customized lab manuals including safety and quality manuals.

 

Inspections and Licensure
Lab regulations are crucial. We assist you in gaining your CLIA certificate of compliance or certificate of accreditation for your lab. NEXT also offer mock inspections and consultation for corrective actions for compliance

 

Management
After your molecular lab goes live, you have the option to continue to use our management services for ongoing optimization and technical support to the further guarantee of a successful and smooth running molecular lab.

Clinical Results Interpretation and On-Call Consulting
Consulting include genetic counselor services, report interpretation, direct physician consulting, and technical trouble shooting.

Quality Assurance Support
Consulting program can provide QA oversight, QA manual, SOP writing/review, audit prep and review, proficiency testing support, Continued Education (CE) programs and support, equipment calibration and maintenance support, validations, safety and compliance testing and support. Support for CLIA, CAP, COLA state licensing.

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Billing Support

Licensing for CMS, Medicaid, MOLDX, as well as in-network applications for insurance providers. Billing support including, coding, pricing, policy support, FAP, zcode application, pre-authorizations for insurance.

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IT and Informatics Support

IT consulting and support, LIMS development, implementation and maintenance, hardware and software consulting support and training. Informatics pipeline development, off-site bioinformatics support, report development and distribution.