In recent days, the Pharmacogenomics (PGx) community witnessed a significant turn of events as Translational Software, a key player in providing pharmacogenetic decision support services, announced its intention to halt operations in the U.S. by the end of the year. This decision came in the wake of a failed attempt to secure regulatory clearance from the Food and Drug Administration (FDA) for its PGxPortal platform. The tremors of this announcement are expected to resonate across the industry, not just affecting the nearly 100 laboratories and healthcare organizations dependent on Translational Software’s services, but also shaking the foundation of regulatory understanding in the PGx space.

Pharmacogenomics: A Brief Primer

Pharmacogenomics is at the juncture of personalized medicine, aiming to tailor drug therapy based on an individual’s genetic makeup. It’s a field that promises to optimize drug efficacy and minimize adverse reactions, thereby enhancing patient care and reducing medical costs. Genetic counselors play a crucial role in this process, helping to interpret complex genetic information to guide clinical decision-making and patient understanding.

The Heart of the Matter: Translational Software’s Regulatory Hurdle

Translational Software sought FDA’s 510(k) clearance for its PGxPortal, a cloud-based solution that processes genetic analysis from lab partners, assigns diplotypes, and interprets the implications on patients’ drug responses. However, the FDA expressed concerns about its diploid calling feature and the fact that the platform provided treatment recommendations based on guidelines from bodies not recognized by the agency. The failure to secure clearance has left Translational Software’s clientele scrambling for alternative reporting tools as the year-end cessation of services looms.

The Ripple Effect on the Industry

The exit of Translational Software has broader implications:

1. Uncertainty and Compliance:

- The FDA's decision casts a long shadow of uncertainty on the regulatory compliance of other clinical decision support platforms. The industry is now left parsing through the potential regulatory implications, trying to ascertain if the FDA's decision is an isolated case or a signal of broader enforcement to come.
- The ambiguity extends to whether the FDA views these platforms as medical devices, which would subject them to a more rigorous regulatory framework.

2. Impact on Genetic Counseling:

- Genetic counselors rely on accurate and actionable genetic information to guide patients and healthcare providers. The regulatory uncertainties around PGx decision support platforms may pose challenges in accessing reliable PGx information, potentially affecting the quality and effectiveness of genetic counseling.

3. Search for Alternatives:

- The void left by Translational Software propels laboratories and healthcare organizations to seek other tools for reporting test results. This could spur innovation as companies strive to develop platforms that not only meet clinical needs but also navigate the regulatory landscape successfully.

4. Market Dynamics:

- This scenario might lead to a reshuffling of market players with some companies potentially gaining a larger market share. Firms like Thermo Fisher Scientific, Agena Bioscience, and others offering PGx reporting tools might find an expanded user base.

Looking Forward: Regulatory Clarity and Collaboration

The unfolding situation underscores the critical need for clear regulatory guidelines that can foster innovation while ensuring patient safety and data accuracy. It’s essential for regulatory bodies, industry players, and stakeholders to engage in constructive dialogues to build a consensus on regulatory standards.

Additionally, initiatives like the Standardizing Laboratory Practices in Pharmacogenomics (STRIPE), aimed at establishing consensus standards, are steps in the right direction. They not only seek to communicate concerns to the FDA but also aim to foster a collaborative environment to address the challenges in PGx testing and reporting.


The cessation of Translational Software’s services is a poignant reminder of the complex regulatory landscape that the PGx space navigates. It calls for a concerted effort from the industry, regulatory bodies, and the broader healthcare ecosystem to work towards clear, consistent, and conducive regulatory frameworks that can propel the field of pharmacogenomics and genetic counseling forward.

In the interim, genetic counselors, PGx labs, and healthcare providers will need to adapt to the evolving scenario, explore alternative platforms, and continue to advocate for regulatory clarity to ensure that the promise of personalized medicine continues to advance in a manner that is safe, effective, and in the best interest of patients.

The Genome Gurus at Cover My Genetics

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