Cordlife suspension extended for up to 3 months till September 2024

Source: The Straits Times
Author: Lee Li Ying

SINGAPORE - Troubled private cord blood bank Cordlife will have its suspension extended for up to three months till Sept 15 as the company needs more time to validate its cord blood processing system.

The company was issued a six-month suspension that was due to end on June 15. During the suspension period, the cord blood banking company had to cease collecting, testing, processing and/or storing any new cord blood and human tissues.

It also could not provide any new types of tests to patients.

In a bourse filing on the Singapore Exchange on May 28, the company said that the Ministry of Health had conducted inspections on the company in April and May 2024 to evaluate the company's progress in rectifying lapses that had damaged the cord blood units of some 7,500 cord blood units.

It was issued with a notice of the extension of the suspension on May 27.

With this extension, the company has 14 days to make written representations to MOH, but Cordlife said it does not intend to do so.

MOH found that the company has yet to complete the validation of its AXP II System for cord blood processing, the development of its relevant operating procedures and practices for the system, and the training and competency assessment of its staff in using the system.

"Additional time will also be needed, to assess the validation data, approve the outcome of the validation, review and approve the SOPs (standard operating procedures), and conduct staff training and competency assessments, and MOH has assessed that the completion of all requirements will take around three months from June 15, 2024," said the company.

Cordlife added: "MOH has further stated that the fulfilment of the foregoing requirements is vital to the company's proper resumption of its cord blood banking service operations."

Cordlife said it will continue to make efforts to expedite potency testing to validate its cord blood processing system, on top of other rectification efforts. It will update MOH on its progress to fulfil all requirements and receive approval to resume operations as soon as possible.

Cordlife also said in the same bourse filing on May 28 that it had applied on May 15 to stop providing services relating to haematopoietic stem cells (including bone marrow) under its human tissue banking service, and for now will be focusing only on the provision of services relating to the banking of ocular tissue.

On the same day, the company also applied to discontinue its clinical laboratory service licence from May 20, 2024.

The company said both moves are not expected to have any significant impact on the company's operations in Singapore because the provision of peripheral blood stem cell (PBSC) banking services did not account for any significant portion of its services, and the company was not providing any services that required the clinical laboratory service licence.

"As MOH investigations are still ongoing, the company is unable to assess the exact financial impact on the financial performance of the group for the financial year ending Dec 31, 2024. However, any continued suspension of the group's operations in Singapore in relation to its cord blood banking services, along with the fixed costs being incurred during such suspension, is expected to continue to have a negative financial impact on the group," added the company.