Nexsen has announced plans to enter the hospital market for Group B Streptococcus testing with a test that already has a European CE mark, rather than building its own molecular test.
The company has signed a non-binding term sheet with FlashDx Shenzhen to form a 50-50 joint venture. The venture would develop and sell an enhanced version of FlashDx's molecular GBS test.
"The proposed joint venture with FlashDx has the potential to materially accelerate Nexsen's commercial strategy," managing director Mark Muzzin said.
The FlashDx test runs on an automated real-time PCR system and gives results from a vaginal swab in under an hour. Nexsen said it uses the same approach as the product the US Food and Drug Administration has cleared for use during labour.
Nexsen will add a sample preparation step designed to pick up GBS when bacterial levels are low. "That gives us a much more advanced starting point than developing a molecular system from scratch, while still allowing us to build a product specifically for the regulatory and commercial pathways we are targeting," Mr Muzzin said.
Nexsen will lead and fund the work toward FDA 510(k) clearance and European IVDR conformity, with support from three US clinical sites. FlashDx will provide the platform, manufacturing, and trial materials. It would be the venture's sole supplier and would hand over its GBS cartridge intellectual property once approvals are secured. Profits would be split equally. The deal still needs binding agreements before it goes ahead.
The new test will not replace StrepSure, Nexsen's rapid lateral flow test for antenatal screening. "The enhanced molecular product is intended for hospital and intrapartum testing, while StrepSure is being developed for antenatal screening and decentralised care," Mr Muzzin said.
The first market will be Hong Kong, where Nexsen has research facilities and a partnership with Gleneagles Hospital. India is also a target.
The case for the test comes down to timing. Between 10 and 30 per cent of pregnant women carry GBS, according to the World Health Organization. Screening usually happens at 36 or 37 weeks, but a woman's GBS status can change by the time she goes into labour, which is when newborns are most often infected. GBS is linked to around 150,000 stillbirths and infant deaths each year.
