CONSUMER healthcare company Cordlife Group : P8A 0% was on Thursday (Nov 30) issued a notice to stop collecting new cord blood and human tissue after a Ministry of Health check found seven of the company’s 22 cord-blood storage tanks being kept at temperatures above acceptable limits.

The ministry said in a statement the company has been barred from collecting, testing, processing and storing new cord-blood or tissue samples for six months. The suspension is to start within two weeks of the notice.

MOH said the licensed cord blood bank exposed cryopreserved cord blood units at suboptimal temperatures, damaging the cord blood units belonging to at least 2,150 clients and rendering them unsuitable for stem cell transplant purposes.

The mainboard-listed group will also not be allowed to run new types of tests on patients for the duration of the suspension. The company has to file its written representations within 14 days, said MOH.

The seven affected storage tanks hold, in deep freeze, a total of 19,500 cord-blood units belonging to 19,200 clients.

Cordlife Group, which has been in the business for 22 years, has been offering parents the option of storing their babies’ cord blood units for a fee.

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The blood from an infant’s umbilical cord and placenta is rich in stem cells and can be harvested to treat a variety of illnesses the infant may develop later in life. Stem cell transplants can be used to treat blood diseases and some cancers, such as leukaemia and lymphoma.

Unannounced audits by MOH, carried out in August and November, found that the seven storage tanks had been exposed to temperatures above -150 deg C. Being stored at suboptimal temperatures triggers a thawing of the cord-blood units, which could damage the stem cells in them.

Since the exposure was discovered, Cordlife Group has completed testing the cord-blood samples in one of the seven tanks. These samples make up 2.7 per cent of all cord-blood units stored by the group’s blood-banking facility in Singapore.

An independent panel of three cord-blood banking specialists appointed by MOH to review these test results concluded that the units have been damaged and are unlikely to be suitable for stem-cell transplant purposes.

But Cordlife Group said in a statement that it will continue to store these cord-blood units for clients, because they “may still be valuable in light of developments in the field of cell and gene therapy”.

Investigations are ongoing for the remaining six storage tanks, which contain about 17,300 cord blood units belonging to an estimated 17,050 clients, said MOH. Pending the outcome of the investigation, MOH will ask experts to determine whether similar tests need to be done for the cord-blood units in these six tanks.

MOH said it found other process lapses, such as the failure of Cordlife’s temperature monitoring system to send notifications of temperature excursions in two tanks between February and June 2022.

The ministry also found that the group’s six-month preventative maintenance was not carried out for two tanks in 2022, and that the group had implemented a new cord-blood processing method in August this year that was not properly validated to “approved plan and protocol”.

MOH said it will consider further enforcement action, including imposing financial penalties and prosecution, as investigations are ongoing.

Meanwhile, the ministry has asked Cordlife Group to take remedial actions to address the lapses, and to strengthen its governance and processes; it is also to reach out to all its clients to address their concerns.

Cordlife Group said it will initiate viability testing of donated cord-blood samples stored in the unaffected tanks.

Tan Poh Lan, Cordlife Group’s group chief executive, said this is the first time such an incident has happened in the group’s history. “We recognise that we have fallen short of the high standards that we hold ourselves to, and we sincerely apologise to our clients and will work diligently to regain their trust,” she added.

The group will work with MOH to strengthen its laboratory processes, procedures and staff training, she said.

Cordlife Group added that, due to the uncertainty of the outcome of the ongoing investigations, it is unable to assess the financial impact of this episode on the group for the financial year ending Dec 31, 2023.

Its shares closed Thursday at S$0.455, up 1.1 per cent or S$0.005.