MOH approves genetic testing of IVF embryos as mainstream clinical service

The Health Ministry said these services should be carried out only for couples at risk of passing on serious genetic disorders.
The Health Ministry said these services should be carried out only for couples at risk of passing on serious genetic disorders.PHOTO: ST FILE

SINGAPORE - Would-be parents who are at risk of passing on serious inheritable diseases to their offspring can now choose from more service providers offering genetic screening.

Pre-implantation genetic testing (PGT) for monogenic or single-gene defects (PGT-M) and chromosomal structural rearrangements (PGT-SR), previously available under a pilot programme, are now classified as mainstream, regulated clinical services with effect from May 1.

"The introduction of PGT-M and PGT-SR as clinical services allows patients who require these services to potentially access a larger selection of providers, beyond those in the pilot programme," the Ministry of Health (MOH) said in a statement on Tuesday (May 4).

PGT-M and PGT-SR, previously known as pre-implantation genetic diagnosis, have been available in Singapore since 2005 under a pilot programme.

No change has been made to the eligibility criteria for patients to receive these treatments. MOH said these services should be carried out only for couples at risk of passing on serious genetic disorders such as harlequin ichthyosis, beta thalassemia and Huntington's disease.

"Based on findings from the pilot programme, PGT-M and PGT-SR were found to be safe and able to reduce the likelihood of live-born offspring being affected by these serious inheritable diseases," MOH said.

The live birth rate per embryo transfer from PGT-M and PGT-SR under the local programme is also in line with that of overseas centres, it added.

Couples who are undergoing assisted reproduction treatment can access PGT services through both existing providers that meet the regulatory requirements, and new providers when they receive approval.

Hospitals and clinics offering assisted reproduction services and clinical laboratories that currently offer or wish to offer PGT will require approval from MOH to continue or begin offering these services.

They must also comply with the relevant regulatory terms and conditions under the amended Private Hospitals and Medical Clinics Regulations, the ministry said.

Some of the conditions that approved service providers will have to comply with include regulations on the clinical conditions for which PGT-M and PGT-SR are allowed to be carried out and the types of information they can provide to patients.

For example, the clinic is not allowed to include information about the sex of the embryo or any other genetic traits that are not related to the inheritable condition.

The service providers will also have to comply with requirements on personnel training and competency.

Providers who offer PGT-M and PGT-SR services without the necessary licence and approval from MOH may be prosecuted. They can be fined up to $2,000, jailed for up to a year, or both.

Hospitals and clinics that violate the regulations may also have their existing hospital or clinic licences suspended or revoked.

The ministry said it had received nine applications from hospitals and clinical laboratories to offer PGT services as at May 1.

The list of approved centres that eligible patients can go to will be made available on the MOH website.

In response to queries from The Straits Times, the MOH said there will be no immediate change to the level of financing support that couples will receive for PGT-M and PGT-SR services, but it is reviewing the longer-term funding approach. The ministry said more details will be announced in due course.