PHYSICIAN OFFICE LAB
Molecular Update How molecular testing is used, changing, shaping new markets and impacting diagnosis and treatment.
By Jim Poggi
In times of need, major leaps in technology adoption can revolutionize a market, and our lives as well. Think of
the automobile, the internet, antibiotics and air travel. In 1900, none of these technologies existed. Today, they are all essential to our daily lives and, as important as they are, they are constantly changing and improving, becoming faster, more accessible, less expensive and more user friendly.
Molecular tests are widely applicable for diagnosis and treatment monitoring for many diseases including cancer, genetic diseases, influenza and others. The COVID-19 pandemic has caused the emerging technology of molecular testing to achieve a speed of adoption that is unheard of due to the critical need for faster, more sensitive and specific diagnostic technology. At the same time, molecular technology has evolved from large, relatively complex systems more well suited for use in sophisticated tertiary care hospital and reference laboratories to products used every day in physician office labs, even in waived testing settings. This column will examine how molecular testing is used, changing, shaping new markets and impacting diagnosis and treatment.
History of molecular testing The rationale for development and deployment of molecular tests is pretty straightforward for infectious disease diagnosis. Conventional microbiology plated media testing has several well-known drawbacks: it takes up to two days to identify the organism, it is highly technique 4
October 2021
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dependent, nearly impossible to automate and does not lend itself to automated reporting of results. Even in the early going, molecular testing had advantages in terms of speed, specificity, sensitivity, automation and convenient LIS/HIS data management. In short, the market was ripe for an innovative solution. Over time, the larger more forward-thinking tertiary care hospitals began employing PCR and other molecular testing methods selectively for infectious disease testing. For inherited disease predisposition, the availability of whole genome sequencing was a fundamental step forward in understanding heritable conditions that might pass down based on parental genotype. Fast forward to 2019 and the beginning of the COVID-19 pandemic, and the rate of change accelerated quickly. Emergency Use Authorization, rather than the more rigorous 510(k) clearance process led to a torrent of new molecular assays. How many you ask? As of August 2021, there are 255 molecular tests available under EUA for COVID-19 alone. While there was already a waived molecular influenza test in point of care, nothing could have prepared us for what the COVID-19 pandemic unleashed.
