SINGAPORE - An estimated additional 5,300 cord blood units (CBUs) from a tank and a dry shipper at Cordlife are unlikely to be suitable for stem cell transplant purposes and have been deemed non-viable, said the Ministry of Health (MOH) in an update on April 8.

More tests need to be done on CBUs in five other tanks to achieve more statistically significant results, the ministry added.

Cordlife expects to take a year for tests of the five tanks to be completed due to their complexity, said an MOH spokesman.

Processes at the cord blood banking company have been in the spotlight after it was revealed on Nov 30, 2023, that cryopreserved CBUs in seven of its 22 storage tanks were exposed to suboptimal storage temperatures.

It was previously announced that around 2,200 CBUs in one of the affected tanks, called Tank A, were damaged and rendered unsuitable for stem cell transplants.

The latest update comes after a third-party laboratory conducted tests on cord blood samples to establish the viability of 19,700 CBUs in six cryogenic tanks and a dry shipper (a container to transport CBUs at extremely low temperatures).

MOH had previously said that test results would be released by end-March.

In the media statement on April 8, MOH said the definitive way to conclude the viability of the CBUs is to individually test all the CBUs in these affected tanks.

“However, this is not practical as it would take many years, even decades, to complete all the tests. Instead, Cordlife conducted sample testing through a third-party laboratory. This will provide a preliminary, but meaningful, indication if the warming events had impacted the cord blood units stored in these tanks,” said the spokesman.

In a bourse filing at 6.37pm on April 8 after the release of the MOH statement, Cordlife gave more details of how the tests were conducted.

It said six donated CBUs were selected from each tank for testing to ensure adequate coverage of temperature variations across the tank. If more than one CBU failed the first round of testing, another six donated samples were selected from the same tank for additional testing.

MOH said the study results and root cause analysis indicated the CBUs stored in Tank B and the dry shipper were at high risk of being adversely affected.

Cordlife called Tank B and the dry shipper “high-risk tanks”, and said the first batch of testing from such tanks did not yield conclusive results, and additional donated CBUs were tested.

Eight out of 12 samples from Tank B and five out of 12 samples from the dry shipper had failed the tests, said MOH.

Based on the detailed analyses carried out, Tank B and the dry shipper recorded the highest temperature excursions of minus 11.6 deg C and minus 132.6 deg C, respectively, Cordlife said.

“The root cause analysis indicated there was insufficient liquid nitrogen maintained in Tank B, which had not been rectified due to failure of Cordlife’s staff to act on and escalate the anomalies. The dry shipper had also not been adequately monitored,” said the MOH spokesman, adding that as a result, the CBUs are deemed unsuitable for stem cell transplants.

The other five tanks (Tanks C to G), which store about 14,000 CBUs, have been assessed through the investigations as low risk of being adversely affected by the temperature warming events.

Cordlife called these tanks “low-risk tanks”. All 30 samples from across these tanks have passed viability and potency tests conducted by an independent third-party laboratory.

The root cause analysis indicated that the temperature warming events in four (Tanks D to G) out of five tanks were likely due to misplaced temperature probes during scheduled maintenance, or incorrect mapping of the temperature probe to the tank.

For the fifth tank (Tank C), the duration of exposure to the highest temperature of minus 144.7 deg C might not have caused damage to the CBUs.

Cordlife said the tank went above the minus 150 deg C threshold for five hours, and a detailed analysis showed the temperature excursion was caused by a delay in replenishing liquid nitrogen.

“MOH’s experts have recommended that Cordlife test a larger number of cord blood units in these five tanks to achieve more statistically significant results (at 99 per cent confidence level). Cordlife has since agreed to test over 200 additional samples across these five tanks and will review the outcome of the test results in consultation with our experts,” said its spokesman.

As the tests, which involve complex processes, have to be carefully carried out, Cordlife expects to take about another year to complete the tests, added the ministry.

Cordlife said that during this process, it will pause any applicable billings for the five tanks until the results of the additional testing are released, with each tank being assessed individually.

It added that it is concurrently looking for other testing laboratories, both overseas and in Singapore, that can test the samples to speed up the process.

MOH has instructed Cordlife to inform its affected clients if their CBUs fall under the impacted tank (Tank B) and dry shipper, or the other five tanks (Tanks C to G) that have a low risk of being affected but are awaiting further tests.

The ministry said affected clients of Cordlife are advised to be patient and await these results before making any decisions, including the transfer of CBUs to another cord blood bank, given that there are significant risks involved in the transfer of CBUs.

“MOH will continue to closely supervise Cordlife’s rectification of the weaknesses identified in their governance structure, processes, systems and documentation.”

Cordlife said it will be offering a refund of annual fees received since the start of the temperature excursion and will waive subsequent fees for all active clients whose CBUs are stored in the high-risk tanks. It will also continue to store CBUs for these clients until the maturity of their service agreements when their child turns 21.

It estimated that the refund and waiver of annual fees for all affected active clients would lead to a fall in revenue and profit before tax of about $9.2 million, which it said would have an adverse impact on the results for the financial year ending Dec 31, 2024.

Mr Ivan Yiu, group chief executive of Cordlife Group, said: “Cordlife Singapore has been working tirelessly to resolve the issues identified by MOH last year and provide clarity for our clients.

“All the donated samples tested from the five tanks under investigation have shown cell viability and potency. However, we know there is more work to be done, and we will continue to test a statistically meaningful number of cord blood units from the low-risk tanks to make sure all of our clients have the answers and results they need.”

He added: “We sincerely apologise to all of our clients for the distress caused by this situation. We recognise the need to resolve the situation as quickly as possible.”

Seven of Cordlife’s senior executives have been arrested for potential breaches of the company’s disclosure obligations in relation to its mishandling of CBUs.

They are former group CEO Tan Poh Lan, chief financial officer Thet Hnin Yi, acting chairman Ho Choon Hou, independent directors Yeo Hwee Tiong and Titus Jim Cheong Tuck Yan, non-independent non-executive director Chow Wai Leong, and non-independent non-executive director Yiu Ming Yiu.

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This article was first published in The Straits Times. Permission required for reproduction.