An image of liquid samples involved in molecular diagnostic PCR testing

As we discussed in our previous blogs, transitioning to molecular diagnostic PCR testing in other infection categories — particularly as COVID-19 testing slows down — is an important and practical next step in driving revenue growth and in making molecular diagnostic PCR testing the preferred method for clinical diagnostics. Although this may be a necessary step for your practice/lab, it doesn’t mean it will be easy. In today’s post, we will discuss the complexities of incorporating molecular diagnostic PCR testing into your practice/lab as well as both the advantages and disadvantages of testing in-house versus referencing it out.

There are three main scenarios most people fall into within this model:

  1. The practice/lab provides all molecular diagnostic PCR testing in-house
  2. The practice/lab provides some molecular diagnostic PCR testing in-house and sends out other parts (specific panels) to a third-party reference lab.
  3. The practice/ lab references or “sends out” all of its molecular diagnostic PCR testing samples to a third-party reference lab (there are certain regulations that impact this option that we will discuss later).


Before deciding which scenario best fits your needs, you want to ask yourself these questions:

  • Am I CLIA certified and do I have the correct CLIA certification?
    First of all, what is CLIA? As explained by the Centers for Medicare and Medicaid Services (CMS), “The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.”Even if you were previously testing COVID-19 samples, you may not have the correct CLIA to move forward with another molecular diagnostic PCR testing. However, “laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct,” according to the U.S. Food and Drug Administration (FDA). You will need either a moderate complexity or high complexity CLIA license to be compliant, which means if you are operating under a CLIA waived license for COVID-19 testing, you will need to apply for a higher level of license from CLIA.There are also seven accreditation agencies approved by CMS, most notably the College of American Pathologists (CA) and the Commission on Office Laboratory Accreditation (COLA). These agencies have standards equal to and usually higher than CLIA, giving your providers even greater certainty in your lab’s accuracy.
  • Do I have the capabilities to test for a large number of pathogens?
    Insurance companies only want to cover small panels (3-5 pathogens), but physicians expect large panels of 20-30 pathogens. This creates a conundrum for the lab. The physician wants lots of diagnostic data and insurance companies don’t want to pay for it. This means, as a lab, you need to be very cost-efficient to ensure you can satisfy the physician’s needs and at the same time make sufficient margin to build your lab. While challenging, some labs have molecular biologists that are able to internally create reagents for their pathogen assays which help reduce costs when compared to buying from a third-party supplier.When figuring out your test costs and reimbursements, you will want to make sure you can actually be profitable in providing any particular PCR large panel test.
  • Can I produce fully validated panels?
    Panels must undergo a validation process to ensure they are producing accurate results. Each tested pathogen — in addition to the reagents being used to test such pathogens — must be validated following strict guidelines established by CLIA. This is not an easy process to accomplish and is a significant barrier to a lab being able to build their market because, until validation is complete, the lab can’t perform the test in-house.

In Part 2 of our blog series, we will discuss the advantages and disadvantages of conducting all of your molecular diagnostic PCR testing in-house.

While you are deciding the best course of action for your lab, you can partner with us at NCF Diagnostics and DNA Technologies for all of your molecular diagnostic PCR testing. We provide curated and fully validated large rtPCR panels in all infection categories, each for one low price.  You’ll receive same-day results and white label services at your convenience. Contact us today to learn more!