Commercializing Novel IVDs: A Comprehensive Manual for Success 2019 Supplement

Commercializing Novel IVDs: A Comprehensive Manual for Success 2019 Supplement

In 2017, the in vitro diagnostic (IVD) industry saw numerous, substantial changes that impact the regulatory and reimbursement landscape in the US and worldwide. This brief supplement to Commercializing Novel IVDs: A Comprehensive Manual for Success presents an abbreviated overview of the most important changes impacting the IVD industry. Regulatory changes in the United States (US) and European Union (EU) influencing the industry are highlighted first. These include decisions that affect direct-to-consumer genetic tests, companion diagnostics, and laboratory-developed tests. Newly-created digital health regulations are also mentioned. Next, a brief outline of the joint Food and Drug Administration-Centers for Medicare and Medicaid Services (FDA-CMS) Parallel Review Program is provided.

Though few manufacturers have taken advantage of this relatively new regulatory and reimbursement pathway, a recent decision has brought this program once again to the attention of the media and manufacturers. The final issues discussed are the influence of the Protecting Access to Medicare Act (PAMA) and Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) on reimbursement issues affecting the diagnostics industry.

The changes outlined in this supplement to Commercializing Novel IVDs highlight the dynamic atmosphere for IVD regulation and reimbursement. Given the constantly evolving landscape, IVD manufacturers should consult appropriate subject-matter experts for advice on their specific needs.

Current Regulation

US Regulatory Landscape

In 2017, the Food and Drug Administration (FDA) took several steps signaling a move toward decreased oversight or diminished regulatory burdens for IVDs and lab-developed tests (LDTs), changes that were intended to encourage innovation in the US. These steps included announcements regarding direct-to-consumer genetic tests, finalized guidance for companion diagnostics, and a highly-publicized approval from the parallel review process. Although the intent behind the changes made by the FDA was to simplify regulatory processes for manufacturers, deciding to follow one or more of these pathways could result in systematic operational changes to a company’s development and/ or manufacturing strategies. Therefore, it is essential that manufacturers evaluate the risks and benefits of each program in the context of their product(s).

Direct-to-consumer (DTC) genetic tests

From their market debuts beginning in 2008, FDA has monitored DTC genetic test manufacturers closely. Numerous companies sprang up, offering consumers a means to find out about their ancestry, explore traits like hair color and male pattern baldness, and even identify potential health risks, such as Alzheimer’s disease and hereditary breast cancer, at a reasonable cost and using easily understood packaging (Kaye, 2008). However, these companies soon became the subject of investigations looking into discordant results between different DTC tests and evaluating the potential impact health risk results would have on consumers (Kaye, 2008; Su, 2013). For example, 23&Me was the subject of a 2013 letter by the FDA (US Food and Drug Administration, 2013) that resulted in a temporary halt in providing health risk information to its customers until the company obtained 510(k) clearance or premarket approval for its Personal Genome Service Genetic Health Risk (GHR) test (Knight, 2014; Brice, 2015; Weiermiller, 2015).