A: Prioritization, ownership and funding. Knowing the diagnostic SARS-CoV-2 result is still viewed as the most important test for patient management and directing public health measures. While there is growing evidence that genotyping the virus may be important for patient management, this activity is still highly viewed as more important for surveillance, and therefore the responsibility of public health laboratories.

Likely when we see conclusive evidence that strain identification tangibly impacts patient management, we will see a change in perception of surveillance testing. It will hopefully trigger insurance companies to pay for these tests, as the test would now be considered a “complementary” or “companion diagnostic” rather than a surveillance test and with no reimbursement.

Until the clinical utility is proven, it’s hard to envision payer reimbursement for SARS-CoV-2 strain identification. Therefore, the primary mode of funding will need to be federal, state or local government. If there is funding available for surveillance testing, we believe laboratories will be motivated to establish and perform such tests.

A: The purpose of Population Surveillance programs is to eliminate, or reduce, the disease of concern in the community.  When we accomplish this, Environmental Surveillance becomes necessary to help us understand when disease returns.  This would include testing wastewater and concentrated air samples.  When we see disease return in our Environmental Samples it may be time to again begin Population Surveillance to repeat the cycle and again eliminate the disease.

Schools: Population Surveillance in schools allows for the safe return to the classroom while driving down disease prevalence, not just on campus, but in the local community as well.  Testing, when combined with track and trace programs, allows for mitigation efforts to quickly contain positive cases and reduce overall impact to learning environment.  When combined with hybrid education models, students who are identified through testing as requiring quarantine, may still participate in learning programs virtually, while undergoing additional testing at regular intervals until given all clear to return to in person instruction.

Employers: Employee Surveillance in the workplace allows for the safe access for workers even under the most difficult conditions during a pandemic.  Mission critical employees confidently work side by side with each other when they know infectious disease isn’t present in their environment.  Regular testing of the individuals and the environment, like concentrated air testing, ensure management and individual workers have full situational awareness in near real time on the presence of infectious disease.  And if disease is detected, appropriate evidence-based action is taken, reducing the impact to individual employees and the business they support.

Travel: International travel fell over 75% in 2020 and in some parts of the world passengers are subject to 2 weeks quarantine. New COVID strains are emerging, and vaccination rates are highly variable between countries. Travelers are a difficult cohort, they have large numbers and are Asymptomatic, so tests need to be very sensitive and specific like population screening tests. Rapid Antigen tests sound attractive, but their lower sensitivity means they are recommended for Symptomatic patients. False negatives are detrimental to public health, but false positives are very disruptive to airlines and travelers. We think PCR will do the bulk of testing for international travel as it is universally accepted, the capacity exists and conducting testing in the 2 or 3 days before travel means less time at the airport. High Throughput PCR linked to verifiable results can provide the assurance Governments will require, with testing at airports as a last resort.

The recent global spread of the novel Coronavirus SARS Co-V-2 has necessitated the development of new diagnostic tests and a significant expansion in the global capability to sequence the viral genome to understand the accumulation of new variants of concern. A return to a more normal daily environment will require a combination of testing capabilities for both CoV-2, Flu and other respiratory viruses to allow them to be distinguished from one another and testing for both known variants of concern via rapid, cost effective genotyping such the B.117 UK variant or the South Africa variant and others, as well as continued surveillance for novel mutations via genome sequencing. Novel mutations have been shown to arise from immunocompromised patients (eg, cancer patients) who have long term SARS CoV-2 infections that fail to be cleared by the immune system. The resulting evolutionary pressure on the viral genome results in accumulation of additional mutations which may result in vaccine or therapeutic escape. Monitoring these mutations both in a centralized as well as a decentralized close to the community setting will be critical.

A: Pharmacists need to understand the basic science of pharmacogenomics and its impact on individual patient response.  But perhaps more importantly, they need to also understand how pharmacogenomics plays into the larger picture of medication management.  Genetics in this field shouldn’t be thought of as a ‘silver bullet’ solution but rather as one piece of the puzzle — a piece that has been largely unavailable to pharmacists and physicians in the past.  What will be critical to the successful integration of precision medicine in pharmacy practice will be the availability and use of clinical decision support tools that account for genetics alongside more traditional risk factors like drug interactions and allergies.

A: Pharmacists generally aren’t in the business of ordering lab tests for patients so we need to engage with the physician community and the payer systems to ensure genetic information is available to the pharmacists for them to review.

Secondly, we need to empower pharmacists with the tools and education that make implementation viable within the current workflows. That means some retraining, but also some proliferation of clinical decision support tools that can make use of all of this new data.  These tools need to be fast, reliable and based on solid science and best practice evidence.

Finally, as an industry, we need to reward pharmacy services that provide more comprehensive medication management.  Insurers and CMS need to recognize the value of having expert pharmacy review as part of standard patient care and start paying for those services.  That change can only happen when the economic benefits are shown at population scale.

A: Rapid, pervasive, and cost-effective genomic technologies will enable the creation of a new facet of data. Those technologies exist today in many forms and have broad uses across many medical conditions.

Making meaningful use of that data will be the job of clinical decision support tools that can bring together the best available clinical advice in applications that enhance the current pathways of care.

We also need core infrastructure components like EHRs capable of ordering and displaying findings and recommendations for current and future use.

A: Empowered with increased knowledge and time-saving clinical support tools, pharmacists are already poised to impact the success of medication therapies.  As active participants in choosing the right medicines for their patients, and partners with prescribing physicians, they can impact treatment successes by increasing the speed to getting the right medication into the right patient at the right time.  This equates to improved outcomes by impacting each of the components of public health’s triple aim: greater efficacy and decreased adverse events for the patient, improved population health, and lowered cost of care.

A: U.S. healthcare is a sophisticated, complex yet fragmented ecosystem. Daily responsibilities and how those tasks are executed for physicians and healthcare professionals attending at large academic centers is very different compared to a community hospital setting. Therefore, there is not a one size fits all approach.

For example, knowledge about the value of molecular profiling for cancer patients along with the ability to decipher and utilize genomic results is at reach within many large academic centers, often being exposed to cutting research and participating in clinical trials. Conversely, this is one of the most problematic hurdles in community hospitals, where physicians are frequently overloaded with clinical duties and have little to no time for extra training.

Building out educational programs (medical school and further education) and widespread use of electronic health records (EHRs) – built out to support molecular test ordering, analysis and storage of results – will facilitate adoption in both environments.

A: The overall diagnostic infrastructure supporting the U.S. healthcare system was caught off guard at the start of the COVID-19 pandemic. One key lesson is that we need to invest in a robust yet agile network of molecular diagnostic laboratories that can respond effectively to a variety of testing scenarios.  Operationalizing test development and deployment at scale, supply assurance of appropriate equipment and consumables, access to trained professionals to run the tests, and analysis and storage of data would be a good starting place.

In the midterm, such play would bring not only the benefit of being able to get ready for the next pandemic but establish our infrastructure to support molecular diagnostic testing at scale, in a variety of community environments.

A: In the upcoming months and years, more and later-stage cancer cases will be diagnosed as a direct consequence of missed doctor appointments, including diagnostics and routine screening, that did not occur during the pandemic.

What should we do now? It is imperative that we prioritize molecular testing using approaches that have proven to be efficient and fast, for instance investments aiming to democratize next generation sequencing testing capabilities should be further accelerated.

As well, building for a better future in cancer diagnostics, we need to move forward with diligent and quality testing, providing patients and regulators with meaningful clinical data which will support reimbursement models. We should think about advancing new diagnostics strategies that better incorporate ancillary testing methods such as liquid biopsy, a less invasive, risky, and faster procedure, to support routine cancer diagnostics and reduce the growing pressure on surgical facilities dedicated to collect tissue biopsies.

A: There are three major challenges to overcome:  (1) Developing tools to address broad demographics in rural and urban communities. The vast majority of biomarkers and genomics tools were optimized for populations of European descent, yet many rural and urban communities are not homogenous, but instead are comprised of racially diverse communities, which represent more complex genomic variation. In light of the disproportionate impact of disease of underrepresented communities, such as cancer, we need to develop inclusive screening and diagnostic tools reflecting this diversity. (2) We must continue making the underlying technology easier to use and more accessible, including mobile deployment of testing methods, sample collection methods, and enabling remote interaction with the platforms and data. (2) We must develop and hire a diverse workforce with the expertise to operate complex assays and interpret genomic results.

A: The call to action is to threefold: (1) Advocate for more funding for research in underrepresented groups; (2) Partner with industry to rapidly increase the number of genetic tests available for a diverse population; and (3) Work with institutions to expand the workforce including both molecular technologists and pathologists. This includes creating more training programs in junior colleges and undergrade institutions, integrating molecular medicine into medical school curriculum and providing ample incentives to encourage minorities to participate and accept jobs in rural and underserved communities.