Traditional lab diagnostic tools are being complemented by remarkable new tools. How to help equip your physician office lab customers.
By Jim Poggi, Principal, Tested Insights
From a public health perspective, the U.S. healthcare system has been doing its job well. Since 1950, the death rate due to all causes has been decreasing steadily, while life expectancy has been increasing over the same period. In 2020, the U.S. life expectancy peaked at 78.9 years.
The COVID-19 pandemic upended the overall reduction in U.S. death rate statistics for the leading causes of death for the first time in decades. COVID also decreased life expectancy in the U.S. by over two years according to a study published in Nature. This COVID-related life expectancy trend has recently begun to be reversed. In 2022, U.S. life expectancy once again increased by over 1.1 years according to the Centers for Disease Control and Prevention (CDC), but still lags behind pre-COVID figures.
Breaking long-term trends, leading causes of death such as heart disease, stroke, diabetes, unintentional injuries and Alzheimer disease all saw increases in incidence from 2019 through 2021.
Yet cancer has been a shining example of progress. Cancer death rates have continued to decline. The cancer rate due to cancer in 1950 was 193.9 deaths per 100,000. In 2019 it had decreased to 146.2, and cancer today is one of the few leading causes of death to experience a reduction in death rates year after year.
Improved health habits are a significant factor. Americans experienced a reduction in smoking from 42% in 1965 to 14% in 2019 following the surgeon general’s report definitively linking smoking to lung cancer and chronic bronchitis in 1964. Better diagnostic tools and awareness of the importance of early detection have also contributed significantly. Annual mammograms have decreased breast cancer morbidity and mortality. Multiple breast cancer studies prove that annual mammograms reduce the risk of death due to breast cancer by 35-41%. Fecal occult blood testing along with colonoscopy has improved early diagnosis of colorectal cancer reducing the death rate from 30 deaths per 100,000 in 1965 to 13 in 2019.
More recently, there have been innovative new diagnostic and monitoring tools for cancer. Low dose CT scans have made early diagnosis of lung cancer a reality and are recommended annually by the U.S. Preventive Services Task Force and other advocacy organizations for current and former smokers between 50 and 80 years of age. This diagnostic tool enables diagnosis of lung cancer in earlier stages and dramatically improves outcomes. Even more recently, tumor genotyping assays provide the use of large-scale data to compare the genotype of a patient’s tumor to its vast database of similar cancers and helps to predict outcomes as an aid to monitoring and treatment. For cancers such as prostate and breast where the variability in tumor aggressiveness varies widely, this tool can recommend more individualized patient management saving lives and potentially reducing the need for surgery, biopsy and other more aggressive treatment methods. At the same time, cancer management has benefitted from liquid biopsy and identification of cell free tumor DNA to help guide treatment decisions based on the presence and amount of cancer tumor DNA circulating in the blood stream. Remission and recurrence of cancer can be confidently predicted by objective data for the first time using these tools.
Don’t forget the traditional tests
In the presence of these major improvements in diagnosis and monitoring, it would be easy to forget the impact made by traditional immunoassay tumor marker tests. Prior to the advent of these immunoassays, multiple enzyme assays including acid phosphatase and LDH were identified as associated with cancer, but lacked the specificity to be useful tumor markers and are no longer used for cancer diagnosis.
The perfect screening test for any disease should exhibit several factors including high sensitivity and specificity, wide availability at a reasonable cost, and a low level of false negative and positive results. More precise, sensitive and accurate diagnostic immunoassay tumor marker tools have been a key element in early diagnosis of cancer since their inception in the mid 1960s with the discovery of alpha fetoprotein (AFP) and carcinoembryonic antigen (CEA) as markers for colorectal, liver and ovarian cancer.
Based on this pioneering work which identified assays with the required sensitivity to be reliable tumor markers, a large number of commercially available tumor markers and highly automated lab immunoassay platforms have become available. Your trusted lab manufacturers are the best source of information regarding currently available tumor marker tests and their clinical utility. The National Cancer Institute has published an excellent summary of current tumor markers including immunoassay, PCR, next generation sequencing and other techniques.
These current immunoassay tumor markers provide good sensitivity, relatively low cost and wide availability. But, many tumor markers used alone fall somewhat short of specificity – the ability to tie an abnormal result to a specific cancer. As a result, specificity is still the greatest challenge for stand-alone tumor markers. But combinations of several tumor markers in a panel often referred to as multianalyte with algorithmic analyses (MAAA) tests have become more common in recent years and have improved specificity. An example is the combination of total PSA/free PSA along with a third test p2PSA. The use of MAAA test panels is growing and the range of available MAAA tests is shown in the Clinical Lab Fee Schedule with many of these test panels becoming frequent enough to be listed on the top 100 CLFS tests. They join the growing number of genomic assays rapidly entering the lab market providing enhanced diagnostic value along with high reimbursement.
In our physician office market, many of these tests remain CLIA high complexity and the combination of regulatory requirements for personnel, the relatively uncommon need for these tests and the cutting edge of their technology has not permitted them to migrate to the typical physician office lab. But advancements in technology have typically resulted in downward migration of cutting-edge technology into our market. Be sure to stay in touch with your key lab manufacturers to understand their current and future assay availability developments.
The experienced and successful distribution account manager needs to be well informed on the range of available tumor marker assays to effectively consult with their customers. The table below provides some useful information regarding available tumor markers, their CPT codes and reimbursement.
| Test Name | CPT code | 2024 Clinical lab fee schedule reimbursement | Typical diagnostic | Comment |
| Prostate specific antigen (PSA) | 84153 | $18.39 | prostate cancer | Often used with Free PSA |
| Free Prostate Specific Antigen (Free PSA) | 84154 | $18.39 | prostate cancer | Often used with PSA |
| Carcinoembryonic antigen (CEA) | 82378 | $18.96 | colorectal, others | |
| Alpha-fetoprotein (AFP) | 82105 | $16.77 | Liver, ovarian, others | |
| CA 19-9 | 86301 | $20.81 | Pancreatic, gastric | |
| CA 27-29 | 86300 | $20.81 | Breast | |
| CA 125 | 86304 | $20.81 | Ovarian Cancer | |
| CA 15-3 | 86300 | $20.81 | Breast Cancer | Often used to detect recurrence |
The above chart shows some of the most commonly performed tumor marker immunoassay tests.
For the experienced distribution account manager this information, along with the help of your trusted lab manufacturers can provide useful consultative help to your customers and can guide them to wisely choose tumor marker assays suitable for their practice as part of their overall diagnostic and treatment armamentarium.
In consultation regarding the ways lab tests can diagnose and monitor treatment of cancer, it is important to remember that both complete blood counts (CBCs) and common chemistry metabolic and organ panels are especially useful in completing the overall picture of health of a patient diagnosed with cancer and can assist your customers in providing the best care and being alert to metabolic changes (loss of kidney or liver function for example) that may require immediate intervention.
Lab tests provided at the point of care have long been known to improve the ability for the clinician to initiate or modify a patient treatment program. In our consultative efforts, it is important to consider all the elements of diagnosis important to individual disease states. In the case of cancer, we are clearly winning the battle. Public health authorities and advocacy groups have joined forces to deliver awareness of signs and symptoms patients need to be mindful of as well as healthy living habits to reduce the risk of disease.
Patients are taking notice and are doing their part by engaging in better health habits.
Traditional lab diagnostic tools including tumor markers, CBC and chemistry tests are being complemented by remarkable new tools like low dose CT scans and tumor genotyping. The future is bright, and the successful distribution account manager has an excellent story to tell their customers to help them win the battle against cancer in your community. Spread the word!