CORD-BLOOD bank Cordlife Group : P8A 0% on Monday (Apr 8) said one storage tank – of the six cryogenic storage tanks deemed under investigation by the Ministry of Health (MOH) – and a dry shipper are at high risk of being adversely affected by the temperature excursions.

Cordlife said its cord blood processing and storage facility in Singapore has been sending donated cord blood units (CBUs) from six cryogenic storage tanks and one dry shipper under investigation, to a third-party laboratory in the Republic licensed by MOH for testing.

These tanks house about 19,000 active CBUs. 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 would be selected from the same tank for additional testing, Cordlife said. 

The tank and dry shipper that have been classified as “high risk” together contain approximately 5,300 CBUs from active clients. These units have been deemed by MOH’s expert panel to be at “high risk of being adversely affected by the temperature excursions”.

Temperature excursions are defined as the external or environmental temperatures to which a product may be exposed during transport or long-term storage that exceed the manufacturer’s label claim conditions. 

The 5,300 CBUs are in addition to the 2,200 units in a seventh tank that were previously announced to have been damaged by the temperature excursions and deemed unsuitable for stem cell transplant purposes.

GET BT IN YOUR INBOX DAILY

Start and end each day with the latest news stories and analyses delivered straight to your inbox.

Sign UpVIEW ALL

Cordlife said the first batch of testing from the high-risk tank and dry shipper did not yield constructive results, and additional CBUs that were stored in the duo were tested.  

Only four out of the 12 donated CBUs from the high-risk tank that were tested demonstrated both cell viability and potency. Cordlife said testing was also performed on 12 donated CBUs from the dry shipper, and seven of them demonstrated both cell viability and potency.

The high-risk tank and dry shipper recorded the highest temperature excursions of minus 11.6 deg C and minus 132.6 deg C respectively, Cordlife said. 

These highest temperature excursions were also primarily due to shortcomings in the way temperature checks were conducted, monitored and escalated, causing delays in replenishing liquid nitrogen to regulate tank temperatures, the company noted. 

Cordlife said it cannot be certain about the viability and potency of every CBU stored in the high-risk tanks and will deem that the CBUs in these tanks are impacted by temperature excursions.

As a result, the company will offer a refund of annual fees received from the start of the temperature excursion and waive subsequent fees until the maturity of service agreements when the child turns 21 years of age for all active clients whose CBUs are stored in these two high-risk tanks. 

Cordlife said it will maintain the storage of these CBUs for these clients until their service agreements mature, and will also honour its commitment to find a suitable CBU if the transplant physician determines that the child’s CBU cannot be successfully used solely because it does not meet the viability criteria when an approved cord blood transplant is required.

It added that it has estimated the refund and waiver of annual fees for all affected active clients would result in a decrease in revenue and profit before tax of about S$9.2 million.

This, the company said, will have an “adverse impact” on its financial results for the fiscal year ending Dec 31, 2024.

In a separate statement, MOH said that while the “definitive way” to determine the viability of the cord blood is to individually test all the cord-blood units, it is not practical as it could take decades to complete all the tests.

Sample testing through a third-party laboratory was therefore done to provide “a preliminary, but meaningful, indication if the warming events had impacted the CBUs stored in these tanks”, said the ministry.

The remaining five cryogenic storage tanks deemed under investigation by MOH are at a low risk of being adversely affected by temperature excursions.

In the five low-risk tanks, all of the tested CBUs have shown “cell viability and potency”, Cordlife said. It noted that there are approximately 13,700 active CBUs in these five tanks.

Based on the detailed analyses performed, Cordlife established that the temperature excursions recorded in four of these low-risk tanks were caused by the displacement of the respective temperature probe during routine maintenance for three of them. The fourth tank’s temperature excursions were due to the incorrect mapping of the temperature probe data. 

Cordlife said the temperature of the fifth low-risk tank went above the minus 150 deg C threshold set by the standards from the Association for the Advancement of Blood and Biotherapies and the Foundation for the Accreditation of Cellular Therapy for five hours. The highest temperature recorded during this excursion was minus 144.7 deg C. 

The company said a detailed analysis done on the fifth low-risk tank established that the temperature excursion was caused by a delay in replenishing liquid nitrogen. 

“The current round of testing is a high-level preliminary impact assessment to ascertain the risk of the temperature excursions affecting the CBUs.

Following this, Cordlife said it will send over 200 samples, which it termed a “statistically meaningful number” of CBUs from the five low-risk tanks, for testing to provide more assurance in the testing results.

MOH said the larger sample must reach a 99 per cent confidence level, which means that 99 per cent of the samples tested must pass both potency and viability tests.

The group said it anticipates that it will take up to a year to complete these tests, as it depends on the capacity of the third-party laboratory.

“Cordlife will inform its affected clients of the outcomes of these tests in batches once they have been completed and results analysed, in consultation with MOH’s experts,” the company added. 

Cordlife also said it is in the process of contacting all clients whose CBUs are stored in these low-risk and high-risk tanks to inform them of the results of their respective tanks and the follow-up plans.

MOH advised affected Cordlife clients to be patient and await the results of the further tests 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.

The ministry will continue to closely supervise Cordlife’s rectification of the weaknesses identified in its governance structure, processes, systems and documentation.

Shares of Cordlife last traded at S$0.172, before the company called for a string of extensions to a trading halt that took effect on Apr 1.