Health Ministry extends Cordlife's suspension for up to 3 months

SINGAPORE: The Ministry of Health (MOH) has extended Cordlife’s suspension for up to another three months, the company announced on Tuesday (May 28).

The beleaguered company’s initial six-month suspension was due to end on Jun 15, but authorities have determined that more time is needed to ensure Cordlife can meet requirements to resume its cord blood banking operations.

Last November, it was announced that seven of Cordlife's storage tanks were exposed to temperatures above acceptable limits, damaging cord blood units belonging to at least 2,150 clients. Another 17,000 clients were possibly affected.

MOH had ordered Cordlife to stop the collection, testing, processing and/or storage of any new cord blood and human tissues, or provide any new types of tests to patients, from Dec 15, 2023.

Further inspections were conducted by the ministry in April and May to evaluate Cordlife’s progress in rectifying the issues.

It said 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 AXP II System.

It has also not completed the training and competency assessment of its staff in using the system.

The AXP II System is an automated system for the processing of cord blood units.

"The MOH has stated that potency testing for validating the AXP II System remains outstanding," said Cordlife.

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

"The 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 was informed on Monday about the extension to its suspension for up to an additional three months.

The suspension may end sooner if approval is granted by MOH’s director-general of health, pending the company’s representations to the ministry.

Cordlife said it "does not intend" to submit such written representations to MOH and will inform the ministry.

“The company will continue to make efforts to expedite potency testing, on top of other rectification efforts, and will update the MOH on its progress to fulfil all requirements and receive approval to resume operations as soon as possible,” said Cordlife.

The company also announced that it applied on May 15 to stop providing services related to haematopoietic stem cells, including bone marrow, under its human tissue banking service.

Cordlife will only be focused on providing services related to the banking of ocular tissue, specifically only corneal lenticule.

"This is not expected to have any significant impact on the company's operations in Singapore because the provision of peripheral blood stem cell banking services did not account for any significant portion of its services," said Cordlife.

The company also applied to discontinue its clinical laboratory service licence from May 20.

"Again, this is not expected to have any significant impact on the company's operations in Singapore as the company was not providing any services that required the (clinical laboratory service) licence," it added.

ARRESTS

In an update on May 23, the company said one of its directors, Mr Zhai Lingyun, was in discussions with the police's Commercial Affairs Department (CAD) to postpone his police interview.

He had been due to be interviewed by the CAD on May 21, but the company was informed by Mr Zhai that he was "unable to reschedule his significant work commitments and meetings in China for the month of May".

According to the bourse filing, he is in discussion with the police to reschedule his interview to June.

According to Cordlife's website, Mr Zhai is the chairman of Nanjing Xinjiekou Department Store, which has a 20 per cent stake in Cordlife.

He is also the chairman of Dendreon Pharmaceuticals, an immunotherapy company based in California, as well as Shandong Cord Blood Bank, a cord blood stem cell preservation company based in China.

The company said it would continue to monitor the progress of the investigations and will cooperate fully with all regulatory authorities on investigations. 

Eight people – mainly directors or former directors – have been arrested in connection with the case.

The mishandling of cord blood units was made public on Nov 30, 2023, when MOH announced that investigations against the private cord blood bank were ongoing.

The ministry had received a complaint from a member of the public on Jul 24, 2023, about alleged issues with a storage tank.

It later emerged that Cordlife's board knew of the issue months earlier, in February.

The damaged cord blood units were from one tank that belonged to 2,150 customers. 

About 5,300 cord blood units stored in a second Cordlife tank and a dry shipper have been deemed "non-viable", said MOH in April.