Classification: Official
Publication reference: PRN01409

To: 

• All trusts and foundation trusts:
  • heads/directors of midwifery
  • obstetric clinical directors
  • neonatal clinical directors
  • chief nurses
  • medical directors
• ICS
  • LMNS lead midwives
  • chief nurses
  • medical directors
• Regional:
  • chief midwives
  • obstetricians and neonatologists
  • chief nurses
  • medical directors

Dear Colleagues,

Discontinuation of Hologic fetal fibronectin testing

We are writing to inform you that Hologic have made the decision to cease production of fetal fibronectin (FFN) cassettes, which are used as a preterm birth marker at the point of care. As a result, these will not be available for the foreseeable future. This follows supply disruption of FFN test kits, as notified by NHS England and the Department of Health and Social Care (DHSC) in December 2022.

Further detail has been communicated by the supplier to NHS customers. Manufacture is expected to continue until September but, due to the issues encountered, it is unclear what stock levels will be available.

Please refer to the adjustments in clinical practice previously shared. It is recommended that women presenting in threatened preterm labour should be assessed with an alternative test (Actim® Partus):

1. If this test is negative, the woman can be assumed to be at low risk of preterm birth and as such would not require in-utero transfer or optimisation medications.
2. If the test is positive, the woman should be recommended to deliver in an appropriate unit and receive optimisation medications.

Clinical guidance in the Saving babies lives (version 3) care bundle will be updated to acknowledge these ongoing adjustments in practice. We understand the impact this discontinuation may have on your practice and patient care. Your co-operation and understanding during this transition period are greatly appreciated.

Trusts which are unable to source supply of Actim® Partus through their normal supply routes or via mutual aid should call the National Supply Disruption Response on 0800 915 9964 (UK free phone number) between 9am and 5pm Monday to Friday (excluding bank holidays).

Please be assured of the ongoing commitment to working with emergency preparedness, resilience and response (EPRR) and supply chain resilience colleagues to explore any suitable available options, and to maintain the highest standards of patient care through alternative diagnostic measures. Thank you for your attention to this matter.

Yours sincerely,

Kate Brintworth, Chief Midwifery Officer for England, NHS England
Donald Peebles, National Clinical Director, Maternity, NHS England
Tony Kelly, National Clinical Adviser for Maternity and Neonatal Safety Improvement Programme, NHS England