Identifai Genetics Ltd (ASX:ID1) is seeking to raise $10 million ahead of a proposed ASX listing under the code ID1, as it moves its AI-powered Windrose™ prenatal genetic testing platform towards clinical validation and commercialisation in the United States.
The company is offering 50 million shares at $0.20 each, implying an indicative undiluted market capitalisation of about $38.4 million on completion of the offer. The offer opened on September 10 and is scheduled to close on September 29, with ASX trading expected to begin on October 16, subject to satisfaction of the offer conditions.
Windrose targets broader genetic screening
Identifai's flagship Windrose™ platform combines whole-genome sequencing, advanced bioinformatics and artificial intelligence to provide non-invasive prenatal screening from a single maternal blood sample from around nine weeks of pregnancy.
The platform is designed to assess fetal risk across more than 280 clinically actionable genes without requiring a sample from the reproductive partner. Identifai says this could address a gap in existing non-invasive prenatal testing, which is generally more limited in its ability to screen for monogenic, or single-gene, disorders.
The company cites targeted competitors including BillionToOne's Unity, which covers up to 14 conditions, and Natera's Fetal Focus, which covers 21 genes, compared with Windrose's genome-wide approach.
Interim analytical work involving 50 high-risk pregnancies reported 100% overall accuracy against the diagnostic reference standard. Identifai's prospectus also reports 100% accuracy in detecting pathogenic conditions confirmed by invasive testing, 100% accuracy in fetal sex prediction and a genome-wide area under the curve of 0.94.
US clinical validation and commercialisation
The United States will be Identifai's initial commercial focus, with the company planning to commercialise Windrose through a CLIA laboratory-developed test pathway.
Near-term priorities include completing CLIA certification and analytical validation, progressing a planned US multicentre clinical validation study and preparing for commercial launch in collaboration with sequencing and laboratory partner Inocras.
Identifai is planning a clinical validation study involving about 600 patients across multiple US hospital sites, while its commercial model envisages partnerships with healthcare providers, prenatal care networks, diagnostic laboratories and other strategic partners.
The company has clinical trial collaborations with Northwell Health, the University of Maryland and other US healthcare institutions, and has been accepted into Mayo Clinic's Berg Innovation Exchange. It is also in discussions with major US laboratory networks about a potential commercial collaboration.
About Identifai Genetics
Identifai's technology originated from research at Tel Aviv University beginning in 2016 and has since progressed from proof-of-concept work into a US-focused clinical development program.
Its intellectual property portfolio comprises 11 patent families, alongside proprietary algorithms, software, bioinformatics pipelines and trade secrets developed over more than nine years of research and development.
The company is led by chief executive Eyal Miller, a healthcare and MedTech executive with nearly three decades of industry experience, alongside founder and chief scientific officer Professor Noam Shomron, an internationally recognised genetics and genomics researcher.
