NEW YORK (GenomeWeb) – Cue Health said today that it has raised more than $45 million in Series B financing that it will use to complete development of its first set of diagnostic products, and fund a set of clinical studies to obtain US Food and Drug Administration 510(k) clearance for them.
The firm said that the new investors in the financing round are Johnson & Johnson Innovation–JJDC, Section 32, Dentsu Ventures, Synergy Ventures, Principles of Tarsadia Investments, Pritzker Group Venture Capital, Babel Ventures, and Troy Capital. Returning investors include Sherpa Capital, Cove Investments, and Rohan Oza.
Ayub Khattak, the firm's founder and CEO, said in a statement that its investors have "strong expertise across medical diagnostics, regulatory affairs, and consumer health," and their strategic guidance will be invaluable as the firm moves into the next phase of its business and continues to build its technology platform.
The firm said that it is developing a range of diagnostic products for professionals and consumers, and for use in clinical and at-home settings. According to Cue, its disposable cartridges use advanced DNA/RNA amplification and immunoassay chemistry to generate digital information that is sent to a mobile device.
Earlier this month, Cue Health announced it received ISO 13485 certification from the British Standards Institution. Its scope covers the design, development, manufacture, and distribution of in-vitro diagnostic medical devices used in the detection, diagnosis, and management of infectious diseases, women's health, cardiovascular health, wellness, and other diseases and conditions, Cue Health said.
In February 2016, the San Diego-based company said that it had begun collaborating with Johnson & Johnson's Janssen Pharmaceuticals to develop a quantitative HIV viral load test for resource-poor settings. Under the agreement, which was facilitated by Johnson & Johnson Innovation, the partners anticipated working to develop an affordable, portable, easy-to-use, and internet-enabled HIV quantitative viral load test using Cue's Lab-In-A-Box molecular diagnostics platform.