Should you add molecular testing to your physician office lab?

February 22, 2021

Val DuVernet

Molecular diagnostics, the testing platforms that detect specific sequences in DNA or RNA, constitute an important aspect of today's clinical practice environment. These types of tests are increasingly used to guide patient management, from diagnosis to treatment.

This is particularly true in the fields of cancer, infectious disease and congenital abnormalities. The increased demand for genetic and genomic information has led to the rapid expansion of molecular diagnostic options across the healthcare spectrum.

All of this raises the question:

Should you add molecular diagnostics to your physician office laboratory testing options?

From a primary care perspective, infectious disease diagnosis and management are likely to be the most relevant application of molecular testing. Consider whether the increased speed (tests that now take days could be completed in hours or less) and accuracy (including both sensitivity and specificity) would benefit your practice. Some molecular tests can offer sensitivities that are at least 10 times greater than legacy methods, while also maintaining impressive specificity for the tested substance.¹

Another advantage of molecular testing for infectious agents is the amplification of the tested substance that is inherent in molecular tests. This reduces the concerns about swab sample collection techniques and ultimately reduces the number of false negatives.

In general, the addition of molecular testing to a primary care practice can offer the important benefits of improving antibiotic stewardship and reducing the number of unnecessary or inappropriate antibiotic prescriptions for viral and influenza-like conditions.

The future of molecular testing in primary care practice

Molecular testing offers significant advantages in laboratory testing by improving prospects for accurate, timely diagnosis of diseases. This has become a major reason for their adoption in infectious disease testing. Molecular diagnostics is currently a $17.8 billion global market — and rapidly growing — with infectious disease tests making up the largest share of this market.²

All signs point to increasing adoption. New molecular diagnostic platforms now have a wide range of tests for common respiratory and enteric pathogens that deliver fast, accurate results to guide proper antibiotic prescription. Some manufacturers have a range of methods, including tests that can determine whether the patient's bacteria are resistant to typical antibiotics and help target the most appropriate antibiotic therapy.

Importantly, molecular tests are becoming easier to use, with user-friendly test formats and sophisticated software and hardware to help bring these offerings to more laboratory sites. Some test methods even feature CLIA-waived testing, including Alere I and Roche LIAT respiratory tests. Many other tests are classified as CLIA moderate. Suppliers are competing for increased ease-of-use, more available tests and faster turnaround times. All these factors show promise for wider adoption and new opportunities to improve patient care.

PAMA, MACRA and the adoption of molecular testing

There can be very real financial benefits to adopting molecular testing in your physician office laboratory testing, too. New laboratory reimbursement rates under the Protecting Access to Medicare Act (PAMA) establish a market-based pricing system for lab tests in which Medicare payment is based on the weighted median average of private payor rates.

Molecular testing addresses pressing diagnostic concerns in both primary care and specialty medicine. It's driving much of the future of lab testing in key disease state detection and management and, as such, may have earned a place in your physician office laboratory testing offerings.

For more tips and guidance, continue reading McKesson's six-part series The Primary Care Physician's Guide to Expanding Your Practice with Point-of-Care Testing.

1: http://jcm.asm.org/content/51/2/481.full
2: https://www.marketsandmarkets.com/PressReleases/molecular-diagnostic.asp

Be advised that information contained herein is intended to serve as a useful reference for informational purposes only and is not complete clinical information. This information is intended for use only by competent healthcare professionals exercising judgment in providing care. McKesson cannot be held responsible for the continued currency of or for any errors or omissions in the information.