Global perspectives on clinical adoption of NIPT

Abstract

Objective: The goals of this study were to assess global trends in clinical implementation of noninvasive prenatal testing (NIPT), as commercial tests are marketed increasingly worldwide, and to identify potential challenges for current or future use.

Methods: We surveyed clinicians from 46 countries about the availability of NIPT, their experiences with using NIPT, and their views on clinical, ethical, and legal issues affecting implementation in their countries.

Results: Forty-nine respondents from 28 countries completed the survey. The majority reported that NIPT is available in their country (n = 43) and that they offer NIPT in their current practice (n = 38). Eighteen respondents from 14 countries reported that there are plans to introduce NIPT into routine prenatal care in their country. Test prices varied widely, ranging from $350 to $2900, and several respondents observed that high test prices limited or restricted widespread use of NIPT. Responses varied both across and within countries regarding who is offered NIPT and what the overall screening protocol should be.

Conclusion: This study provides a snapshot of current use and experiences with NIPT globally. It also highlights differences in service provision that exists both across and within countries, emphasizing the need for developing national and international implementation guidelines for NIPT.

Figure 1. Current prices of NIPT around the world

All costs were provided by respondents in their local currency, and were converted into USD (US dollars) to facilitate comparison. Some respondents provided a range of prices (denoted by a vertical colored line) while others provided a single cost (denoted by a single diamond). For some countries, multiple respondents took the survey; as such, prices and ranges were combined. The average test price reported by respondents, approximately $874 USD, is denoted by a red horizontal dashed line. Countries are graphed from left to right in alphabetical order.

Figure 2. Commercial NIPT providers used by respondents in their own medical practices

Thirty nine respondents answered the question “Which of the following companies’ tests do you offer in your practice?” While respondents were provided with both the company and test name, only the company names are presented here. At the time of the survey, Berry Genomics had ceased all operations in China pending approval from the Chinese Food and Drug Administration.