Cordlife granted 14-day extension to respond to MOH on possible suspension

SINGAPORE – Private cord blood bank Cordlife has been granted a 14-day extension for it to respond to the Ministry of Health (MOH) on its possible suspension.

Cordlife Group announced in an Oct 13 bourse filing that it had applied to MOH on Oct 6 for an extension, and the ministry informed it on Oct 12 that the extension had been granted. It now has until Oct 27 to submit its written representations to the ministry.

Cordlife also revealed that since Sept 30, one day after receiving MOH’s Notice of Intent, it has voluntarily stopped the collection, testing, processing and/or storage of any new cord blood units (CBUs).

Cordlife was issued the Notice of Intent after significant lapses were found during MOH’s audit in July.

The company first received a six-month suspension in November 2023 after audit checks found lapses in its storage of CBUs.

It was eventually allowed to resume operations in a calibrated manner from Sept 15, 2024, after MOH was satisfied with the steps it took to address critical shortcomings.

Its licence was also renewed for one year from Jan 14, with a planned midpoint audit by MOH. Such licences are usually renewed for a period of two years.

However, the midpoint audit in July found that Cordlife had failed to keep to various regulatory requirements, including governance, incident reporting and management, as well as processes for collection, testing and processing of new CBUs.

Cordlife initially had until Oct 13 to make representations before the ministry decided whether to proceed with its suspension of Cordlife’s cord blood banking services for one year.

If suspended, Cordlife will not be able to bank new CBUs, but it can continue operations and must ensure the safety and quality of all existing CBUs.

Cord blood contains stem cells that can be used to treat blood diseases and some cancers, such as leukaemia and lymphoma, should the baby develop these illnesses later in life.

In an Oct 6 bourse filing, Cordlife said that if the suspension takes effect, its operations for the next 12 months to Sept 30, 2026, will continue, but its future beyond that is not certain.

MOH earlier shared the latest test results related to the seven CBU storage tanks that were exposed to warmer-than-required temperatures, which could damage stem cells in the cord blood. The incident had led to the six-month suspension in November 2023.

A total of 264 samples from five of these tanks were tested. Samples from three tanks containing 12,000 units did not pass the tests.

MOH has directed Cordlife to conduct a full investigation into the testing results, as it could not identify conclusive reasons for the samples failing to meet the criteria for viability and potency.

In response to queries from The Straits Times, an MOH spokeswoman said the full investigation will involve Cordlife reviewing its detailed lab records from the time these CBUs were collected, as well as a root cause analysis.

She said that when a CBU is found to be not viable, it could be due to the initial samples being of poor quality, or because Cordlife did not adhere to proper processes during banking of the cord blood.

When asked whether MOH has set a timeline for Cordlife to complete the full investigation, considering the Cordlife issue was first revealed nearly two years ago, the ministry did not respond directly, but said it urges Cordlife to complete its probe expeditiously to address its clients’ concerns.

MOH said it is committed to closely supervising Cordlife’s investigation, along with its rectifications for the other lapses.

The ministry did not respond to ST on how the viability of the 12,000 units could be confirmed if Cordlife continues to be unable to identify conclusive reasons for its samples failing the tests, and whether Cordlife would be further penalised for this.

Earlier tests on the first two tanks found about 7,500 CBUs unviable.

The number of affected clients is still unclear, as each client could store more than one CBU with Cordlife.

In the Oct 6 bourse filing, Cordlife noted that the timing, as well as the cash outflow related to the testing required for the three tanks, cannot be determined currently.

Cordlife said the uncertainty it faces also includes potential refunds to affected customers, which may be required depending on the test outcome, claims from customers who allege damage to their stored CBUs, as well as possible fines or penalties imposed on the company as a result of MOH’s suspension.