Table 4.

Selected respondent comments on experiences with and views about clinical implementation of NIPT in their countries

COMMERCIALIZATION
Company Behavior
Italy:	“Too much business involved. Rewards to doctors prescribing NIPT is not an appropriate model but it is the current one.”
India:	“Most obstetricians are still not aware of the test and companies have commercialized the process by offering kickbacks for referring OBs and hence some do the test without understanding the implications or proper counseling.”
Hong Kong:	“NIPT can be offered below HKD 2000 and yet the provider (at least one of the Chinese providers) could already make a good profit from it. These companies and their intermediates (such as private doctors and hospitals) are making huge profit by offering the test at HKD 8000, which is not good for the general public.”
India:	“Several companies claim their technology is better than others. The best seller wins!!”
Test Price/Cost
Argentina:	“The cost of the test makes it unaffordable for most people, and it is still limited to patients who can afford it.”
Israel:	“Still limited use due to high cost.”
Australia:	“Cost is the major barrier to uptake.”
CLINICAL ISSUES
Time to return results
Australia:	“The current 2 week turn-around offered by most companies is a little concerning (they are generally shipped off-shore for analysis) but I believe in future, the NIPT analysis will be done within Australia.”
Greece:	“The shipping to USA is often problematic with delay of results.”
Netherlands:	“It takes too long for the result.”
Test Performance
Hong Kong:	“In general, it is good. There is an example that it was wrongly applied to a fetus with thick nuchal >6mm. It turns out to be a false-negative case of Turner's syndrome.”
Greece:	“High percentage of false positive results for sex chromosomal abnormalities.”
Ireland:	“Low fetal fraction results cause anxiety.”
Counseling
India:	“NIPT is effective after complete understanding of the test by the offering physicians, its advantages and drawbacks and most importantly if it is accompanied with good pretest and posttest counseling.”
Screening protocol
Portugal:	“My opinion is that NIPT should replace screening + invasive testing for aneuploidies in the near future - 2 years?”
Canada:	“Ideally will be introduced in a model that preserves beneficial aspects of existing screening programs, especially ultrasound and biochemistry (if further evaluation supports its role in screening for adverse outcome). Will likely be contingent evolving to primary as the cost decreases.”
Czech Republic:	“Probably it should be offered for women at the high risk, not for general population.”
Netherlands:	“I strongly believe that NIPT should not replace first trimester screening, but run next to it.”
Physician and Patient Education
India:	“At present there is confusion about NIPT availability in India. Awareness about NIPT, its limitations, shortcomings is quite low in medical and general population.”
Hong Kong:	“A common algorithm should be introduced to both healthcare providers and pregnant women for better understanding of the role of NIPT and its limitations.”
Italy:	“Too much enthusiasm, very little knowledge from professionals. Risk to be patient driven without appropriate counseling and knowledge.”
Insurance coverage
Czech Republic:	“It is still very expensive and it is not covered by health insurance companies.”
Chile:	“As a MFM Specialist practicing in a developing country, not all women have Access to NIPT. Chromosomal analysis and ultrasound are available and partially covered by state and private insurance companies. NIPT is not covered at all.”
Canada:	“High patient satisfaction but frustrating that only available on a patient- pay basis at present.”
IMPLEMENTATION
Policy/strategy
Germany:	“Ongoing discussion whether it will be offered to all or only to high risk women. In case of the latter, it is unclear how the high-risk population will be defined. Maternal age is not state of the art anymore but first trimester screening is only offered on a private basis.”
Hong Kong:	“It should be based on women's free choice. A publicly funded coupon will be a much better choice than to be centralized by the government.”
Canada:	“I wish we had a national policy. All provinces in Canada practice differently.”
Canada:	“Ideally will be introduced in a model that preserves beneficial aspects of existing screening programs especially ultrasound and biochemistry (if further evaluation supports its role in screening for adverse outcome).”
India:	“These tests should not be available as direct to consumer tests. We should try to develop NIPT using other techniques/platforms for which kits can be purchased and the test is run in house.”
Cost effectiveness
United Kingdom:	“Unaffordable within NHS budgets at present.”
Czech Republic:	“The plan must be financially feasible.”
Italy:	“The one with most cost benefit advantages might be in the future recommended for all country from national health service.”
ETHICAL & LEGAL ISSUES
India:	“Due to the serious problem of skewed male female ratio in many parts of India and strict control of PC-PNDT act on the genetic diagnosis and screening programs, there is unwillingness on part of the authorities to give clearance for NIPT. We will require a concerted effort on part of clinicians, counselors, genetic laboratories to explain to the authorities about advantages of NIPT, how it can be safely implemented under the PC-PNDT act guidelines so as to ensure strictly legal and proper use of NIPT. If we can have the NIPT testing in India, it will be easier to convince the authorities that the labs performing NIPT will strictly adhere to PC-PNDT guidelines.”
Hong Kong:	“I am a bit worried about "eugenic" in the coming era of next generation sequencing.”
Ireland:	“Very exciting and applicable technology; NI specific legislation restricts what can be done about an abnormal result, as we do not have the GB 1967 Abortion Act. NIPT *may* help force a rethink especially in early pregnancy.”
Norway:	“Norway was the second country in the world (1986) where the government officially introduced general ultrasound screening at week 18. However, the "Down syndrome debate" has since year 2000 been exceptionally strong. In 2004 a law was introduced making it ILLEGAL to practice a GENERAL OFFER of a full first trimester scan. The first trimester scan is only offered to risk groups and the first trimester scan including NT ++ can only be done at the 5 university hospitals. NIPT is not introduced in the country of Norway for detection of chromosomal abnormalities.”