Helping lab professionals GoMolecular.

Start-Up Checklist


In this article:

  • Nine key items to consider before starting a molecular lab
  • Be prepared for a smooth transition


Thinking about starting a molecular lab? In-house molecular-based testing is making sense for more and more medical laboratories across the country. With the continuing development of instruments that automate steps, it is more reasonable to manage this testing option.

The transition to molecular techniques is a serious undertaking for most labs. It involves a big commitment and a lot of preparation. Here is a general overview of what you will need to consider when taking on this exciting new challenge.

1. Suitable testing services. What test menu makes sense for your lab? What services are most useful for your patient community? What is your expected test volume based on current demands or needs? Talk to your clinicians about their experience and opinions. 

2. Space requirements. How much square footage is available to you, or will you need a build-out? Do you have ample space for equipment, storage and refrigeration? Does your floor plan allow for separate areas and workflow that help prevent contamination? Consider hiring a space planner with experience in the medical laboratory industry.

3. Design and construction. Hire an experienced architect and general contractor that best fit your needs and who understand this highly specialized project. Don’t always go for the lowest price — go with the best person for the job. You do get what you pay for. Get references and go see their previous work in person. 

4. Staff training. Do you have individuals who can immediately run tests, or will training be necessary? Can you hire from within or will you need to hire new employees?

5. Cost estimates. Put together a cost estimate detailing expected start-up costs for construction, equipment, test inventory, staff salaries, etc. Conduct a financial assessment that includes overall budget needs, a financial forecast for a three- to five-year period, and expected revenue generation.

6. Profitability. What is the current testing revenue generated in your community? Can you capture part or all of this business from the current market leader? What is the reimbursement rate for specific tests? Keep in mind that your lab may not be profitable right away.

7. Funding. Is a new molecular lab in the budget? Create a well-thought-out business plan. Be prepared to sell your idea to executives and key decision makers. 

8. Certification and accreditation. How will your lab and employees receive the necessary approval to operate? Find out the state and federal requirements. Consider hiring a consultant to help you navigate regulation compliance, meet industry standards, prepare for inspections, and create best practices.

9. Build Connections. Join and get involved with industry associations like College of American Pathologists (CAP) and Association for Molecular Pathology (AMP). Network with other members who are in the process, or have already opened a molecular lab. Ask for advice and to see their lab in action.

Opening a molecular lab is a big project, but it is worth the effort. When you take these items into consideration upfront, you will be prepared for the challenges ahead.