Molecular Diagnostics
The Changing Practice of Medicine.
Molecular Diagnostics:
Molecular diagnostics is a powerful clinical tool that often serves as final testing for diagnosis and treatment of highly complex diseases, such as chronic infections, cancer, inherited genetic disorders, congenital genetic disorders and acquired genetic disorders. It is widely held that, during the next 5 to 10 years, the clinical application of molecular pathology and molecular diagnostics will further revolutionize clinical diagnostics and pharmaceutical and biopharmaceutical discovery, individualized drug dosing, and route of administration of existing and new therapeutic agents and truly personalize medical care.
Certifications and Site Assessments:
Clinical Lab Consulting (CLC) specializes in assisting CLIA-certified laboratories (hospital, governmental, independent reference and physician specialized laboratories) in establishing in-house molecular testing including, molecular genetics, molecular infectious disease, and molecular pathology (tumor and hematopathology markers). Our consulting services are specifically designed for your needs, and for the needs of your clients and patients. We begin each partner laboratory relationship by conducting an on-site assessment and financial feasibility utilizing a return on investment (ROI) model, which provides prospective labs with an analysis of all start-up costs. We will suggest improvements to your current test menus as well as outline future test development. Our assessment is based on several factors including: current referred tests (send-outs), space and room requirements, equipment, supplies and personnel needs.
Services:
Once the financial feasibility and site assessment are completed, CLC experts work with your laboratory staff members to assure all elements for setting up an in-house molecular laboratory are completed with speed and accuracy. This includes, selecting the most advanced technology, negotiating the contract with the vendors, validating and verifying assays (FDA approved, ASR or laboratory developed assays), training laboratory personnel and helping them become comfortable with this highly complex testing. In addition, we work with the vendors to help your sales and marketing team promote these new tests in order to be efficiently utilized by referring physicians.
Our team of consultants are experts in the field and are employed with well know clinical laboratories, and have a record of accomplishment for developing some of the most successful molecular laboratories in the country. These experts are active contributors in the field, are highly published, and have helped established industry wide standards in Molecular Diagnostics CLIA and CAP regulations.
