Since the end of December 2023, we have been sending donated cord blood units (“CBU”) from six cryogenic storage tanks and one dry shipper under investigation to a third-party laboratory in Singapore licensed by MOH for testing. The results have been assessed by MOH, and they concluded that five tanks under investigation are at low risk of being adversely affected by temperature excursions because all of the tested CBUs demonstrated cell viability and potency. This suggests that the CBUs stored in these low-risk tanks have not been compromised. The remaining one cryogenic storage tank and the dry shipper have been deemed by MOH’s expert panel to be at high risk of being adversely affected by the temperature excursions.

The temperature excursion in this tank, while above the -150°C threshold as set by AABB and FACT standards, did not exceed the critical point for CBU storage of -135°C, also known as the glass transition temperature, suggesting there is minimal to no impact on the CBUs stored in the tank.

Cordlife Singapore 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.

In addition, all tested CBUs in the initial round of testing showed cell viability and potency. This suggests that the CBUs stored in your tank have not been compromised. 

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, we will be sending more than 200 samples, a statistically meaningful number of CBUs from your tank, for testing to provide more assurance in the testing results. During this process, we will pause any applicable billings until the results of the additional testing are released.

Cordlife Singapore 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.

We are working with the third-party laboratory in Singapore, licensed by MOH, to conduct thorough and unbiased testing. 

As the tested cord blood units in the initial round of testing showed cell viability and potency, this suggests that the CBUs stored in your tank have not been compromised. 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, the Company will be sending a statistically meaningful number of CBUs from the low-risk tanks for testing to provide more assurance in the testing results. During this process, the Company will pause any applicable billings for the Low-Risk Tanks until the results of the additional testing are released, with each tank being assessed individually.

We have sent out email correspondences to all affected and non-affected clients of Cordlife Singapore. In some cases, the contact information is not up-to-date. If you have not received any email correspondence in your registered email address, kindly email us at supportsg@cordlife.com.

We are currently in the process of updating our clients, whose cord blood units are stored in one of the tanks under investigation, with updates on the testing results of the donated cord blood samples stored in the same tank as their child’s. We will communicate this information via email and by post. 

If your child’s cord blood is stored in the remaining 15 tanks, you should have or will be receiving an email that will state that your child’s cord blood unit is not affected.

We would like to reassure you that your child’s cord blood is securely stored, monitored and remains unaffected. We completely understand that even though your child’s cord blood is not in any of the affected tanks, the issues arising from the affected tanks may have caused you anxiety. We will be conducting an annual stability programme to assess the stability, quality, and viability of our stored cord blood units. After addressing the issues identified by MOH, such as the testing of more samples Low-Risk Tanks, as well as the issues highlighted in our announcement dated 13 December 2023, we will shift our focus to completing this annual stability programme. You will be provided with the results as soon as they become available.

We would like to reassure you that there is a clause in the service agreement you signed with us that protects you if, in the opinion of your transplant physician, it is subsequently determined that the cord blood cannot be successfully used for an approved cord blood transplant solely because it does not meet the viability criteria, Cordlife will make every effort to find a suitable replacement cord blood for your child.

While we recognise that a replacement cord blood unit may not be your first choice, we are committed to finding all available options in order to provide you with the closest match possible. We understand the uniqueness of each individual's cord blood, and we will work with the public cord blood banks worldwide to find a suitable match for your child if the need arises. 

We understand that some clients who have stored multiple cord blood units with us may receive multiple emails. We're providing updates in batches as part of our ongoing verification process. We regret any inconvenience resulting from receiving multiple messages and acknowledge the value of clear communication. Your understanding during this process is highly appreciated. If you have any concerns or need further clarification, feel free to reach out to us.

If you have stored your child’s cord lining or cord tissue with us, we would also like to assure you that cord lining and cord tissue units are unaffected by this incident.

Donated cord blood samples are specimens provided by donors. The approach of using donated samples to monitor conditions within our storage tanks is a standard practice among cord blood banks worldwide. Testing these samples allows us to determine the quality and stability of all stored cord blood units, including yours, that are maintained in the same tank.

We do not recommend conducting viability tests on your child's sample unless it is required for a transplant or infusion to ensure that all segments of the cord blood are preserved. Using donated cord blood samples as proxies, we can determine the condition of other cord blood samples housed in the same tank. This approach is a standard practice adopted by cord blood banks globally.

We anticipate that the testing may take up to a year, but we are looking for other testing laboratories both overseas and within Singapore where we can send our samples to speed up the process.

We are working very closely with MOH to develop measures to prevent such situations from recurring. While doing so, we have enlisted the expertise of the Foundation for the Accreditation of Cellular Therapy (FACT) to guide and reinforce our procedures and organisational structure. We are also in the process of implementing a more robust digitalised lab monitoring system to improve real-time remote and on-site monitoring of our Singapore facility as part of our preventive measures. We are strengthening our fail-safe measures to ensure uninterrupted operations even under adverse conditions, as well as providing extensive training for our staff and increasing the number of experienced technical personnel to boost our lab’s expertise and processing capabilities. These are some of the corrective and preventive measures that the company is implementing.

Furthermore, we conduct an annual stability programme to evaluate the stability and viability of cord blood samples stored over time. This programme includes testing and monitoring donated cord blood units kept under cryogenic conditions to ensure their viability remains intact throughout their storage period. The objective of this programme is to reassure our clients about the reliability of their stored cord blood for potential use in medical treatments or research in the future. 

We would like to assure our clients that the third-party lab meticulously followed stringent protocols and operated under strict quality standards to ensure the accuracy and reliability of all test outcomes. Furthermore, these outcomes have undergone a thorough review by MOH’s expert panel to ensure their quality and transparency for our clients. 

We are unable to provide individualised breakdowns of results for the specific tanks, but we would like to assure our clients that the third-party lab meticulously followed stringent protocols and operated under strict quality standards to ensure the accuracy and reliability of all test outcomes. 

We have increased the frequency and scope of our daily checks on all of our cryogenic storage tanks to ensure more stringent monitoring procedures. We are also in the process of implementing a more robust digitalised lab monitoring system to improve real-time remote and on-site monitoring of our Singapore facility. Furthermore, we are strengthening our fail-safe measures to ensure uninterrupted operations even under adverse conditions, and providing extensive training for our staff. These are some of the corrective and preventive measures the company is putting in place.

We understand that you may be considering transferring your cord blood to another facility, and while we hope you will reconsider, we are here to assist if you decide to proceed with the transfer. However, we would like to highlight that we do not recommend clients take this step for the following reasons:

1. Transferring cord blood from one facility to another requires us to remove the cord blood from the cryogenic tank so that it can be transported. This entails risks. We believe that the cord blood units are safer in their current cryogenic tanks rather than being subjected to the risks of being transported to an alternative provider. 
2. You are currently protected by the Warranty Statement pursuant to the agreement you signed with us, which states that if, in the opinion of your transplant physician, it is subsequently determined that the cord blood cannot be successfully used for an approved cord blood transplant solely because it does not meet the viability criteria, Cordlife will make every effort to find a suitable replacement cord blood for your child. However, should you decide to terminate the Agreement and request that the cord blood unit be transferred to an alternative provider, the warranty will also come to an end. 

We are committed to providing you with a comprehensive update as soon as possible. In addition, we continue to work closely with MOH and have been strengthening our systems, processes, and procedures to prevent such incidents from happening again in the future.