Why the Right PGx Launch Strategy Will Save You Money, Time, and Resources

We’ve highlighted how labs can grow by selling advanced PGx procedures here, and if you haven’t seen it, the field of CGx and PGx has grown leaps and bounds in the last 30 years. While the road ahead may be full of promises of growth and a CAGR of 8% or more in the coming decade, there are still hurdles and perils such as lack of awareness, the cost of the technology, limited data, and regulatory compliance that stand in the way of more growth.

Which isn’t to say that if you’re in the process of exploring launching a PGx product, any of these hurdles should stop you in your tracks. In fact, with the right launch strategy, these hurdles may become nothing more than small speed bumps on the way to a healthy PGx testing program for your hospital or laboratories.

Problems facing a wider adaptation of PGx testing in the healthcare market

Lack of Awareness of PGx

There are plenty of compelling reasons why PGx should be part of most patients’ journeys. As modern precision medicine continues to rapidly evolve, PGx testing has been proven to be an effective tool at improving antidepressant efficacy, decreasing the risk of hematological toxicity in cancer treatment, and decreasing the risk of cardiovascular events, as outlined in this Share with Your Patients, Providers, and Peers on How PGx Improves Patient Outcome – 1health. Yet, despite all the recent evidence and studies confirming the effectiveness of PGx testing as part of treatment, a lack of awareness still hampers wider adaptation. Patients won’t ask for a test they don’t know about, and doctors won’t order a test they’re not aware of.

Expensive Technology

It’s no secret. Genome sequencing technology is expensive today. Certainly not as costly as when the Human Genome Project began in 1990.The cost of the sequencing platform can range from $20,000 on the low end to the price of an exotic supercar on the high end. Not to mention the analysis software that makes the entire sequencing work, and all the ancillary IT hardware that goes with storing, transmitting, and sharing terabytes of data as you scale the PGx operation.

Limited Data Availability and Compatibility

Unlike the vast majority of the healthcare industry, “modern” precision medicine is exactly as it states. It’s modern, using cutting-edge technology and precision data to effect individualized treatment plans to maximize patient outcome while minimizing risks. Many of the databases used today for PGx analysis are limited in scope and depth, and some of the data focuses only on a specific genome or a subset of genomes and its interaction with a specific drug, making a wider adaptation of testing difficult.

Regulatory Hurdles

With FDA approval coming in slowly and the Centers for Medicare & Medicaid Services taking its time to adopt a broader stance on reimbursement, bringing a new PGx testing solution to market presents challenges that few other testing solutions face. Although recent headwinds in this area have changed, with more and more testing coming online faster and gaining wider acceptance.

With these challenges in place, it is more important than ever for your organization to have a proper launch strategy in place to eliminate as many variables and obstacles as possible. Here we’ll break down two separate scenarios and best practices for launching a PGx testing program.

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If You Are a Hospital Testing Lab

According to the Centers for Disease Control and Prevention, 14 billion laboratory tests are ordered annually. As of 2017, 59% of all laboratories in the United States were hospital-based labs according to a Televisory article. For any hospital and its affiliated lab, quickly launching a PGx testing platform today may be cost prohibitive. As a general rule, the most common tests conducted at a hospital are done for speed and expedience, as the patient is treated, key decisions need to be made based on fast turn-around tests such as a basic metabolic panel, a comprehensive metabolic panel, or a complete blood count.

Which isn’t to say that a PGx program requiring genome sequencing cannot be part of a hospital laboratory’s offering. In fact, depending on the volume of testing and the value of modern precision medicine to your hospital’s practice, you may find enough justification to invest in a comprehensive PGx capable laboratory system at a single location that can service a geographical area as part of your hospital system, and provide the PGx testing services to surrounding physician groups and a network of hospitals to recuperate that cost.

Another more cost-effective option is that by law, a hospital system can refer up to 30% of laboratory samples, depending on volume, and still charge under its own billing. A quick way to make PGx accessible to a hospital’s doctors and patients to effectively improve patient outcome would be to contract out and refer to a reference lab that has comprehensive PGx testing capabilities already launched.

Once you’ve identified the laboratory partner to refer your PGx samples to, the hospital system can have a fully functional PGx testing platform available to providers and patients immediately.

If You Are an Laboratory

The strategy for launching a successful PGx program for a lab is a little bit more complicated, since with a hospital system, referring samples out is often the best solution. A laboratory has to worry about having access to the right algorithms and reports for the PGx test they wish to run, having to connect the dry and wet labs and integrate both for speed to market, and deal with connectivity and software issues between the lab and the ordering provider. The hurdles of equipment cost, awareness, and regulations take a back seat if these fundamental operating issues cannot be resolved first.

Choose the right algorithm partner

When your laboratory is ready to embark on the PGx journey, or has already been collecting samples and processing results, a key obstacle in any laboratory’s way is access to the right algorithm or computational partner. By connecting the capabilities of a dry lab (computational) and a wet lab, each laboratory does not need to be burdened with the hurdles and difficulties of having two distinct challenges running under the same roof. Using a platform like 1health.io can help your lab partner with the right algorithm partner, offer a simple workflow with a minimum burden on your IT resources, and access a modern dashboard to improve your customer and physician interface.

Speaking of interfacing your physician…

Next generation clinical ordering and patient dashboard

To broaden your laboratory’s PGx footprint and gain access to wider adaptation, the best next-generation clinical ordering interface that can ease the process of inputting orders by physicians and a simple-to-use dashboard that can provide a 360º view of the order process from sample to result at the provider’s fingertips will accelerate PGx testing adaptation.

Of course, it is still incumbent on the shoulders of laboratories to partner with the best service providers to market their PGx services to physicians, and communicate with and educate the healthcare community overall on the benefits of PGx to patient outcome.

Communicate and Educate

Having the test capabilities in place is just the first step. In order to gain wider awareness, a lab should consider partnering with marketing providers well versed in the healthcare and testing space to increase adaptation of the test. Use of regular email campaigns, LinkedIn messaging, hosting webinars for networked physicians, and follow-up are crucial to generating a return on your investment.

Partner with 1health.io

A lot of these strategic steps may seem daunting, especially for hospital systems and labs that have never launched a new service like PGx. That’s why a key strategy is to reach out to 1health.io and audit your capabilities to form the right strategies. 1health.io has successfully helped multiple labs and partners launch new PGx tests, direct-to-consumer kits, and a variety of innovations that have helped generate more than $270 million in new revenue.

Our powerful platform delivers end-to-end solutions to help labs streamline their processes, gain efficiencies, and enhance their accessibility, while our flexible APIs enable lab customers to drive better patient engagement and compliance through uniquely accessible and impactful solutions. In addition, the 1health production systems and data are hosted on a platform that is certified compliant with the SOC 2 Type 2, HITRUST, HIPAA and ISO 27001 standards. In turn, the solutions offered are designed to help them maintain this data integrity and stay compliant with HIPAA, GDPR and all related health information regulations.

By partnering with 1health.io, we offer you the most experienced partnership to help you go-to-market smoothly with your latest PGx capabilities.

Contact our sales team to book a demo today.

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