The multiplexed PCR kit will target mutations associated with cystic fibrosis that are highly prevalent in the US, and the firm is also eyeing the Middle East and Africa.
Castle will use the proceeds to accelerate marketing and new product development related to its molecular prognostic tests for patients with underserved cancers.
The firm's Cxbladder Monitor test was shown to have a high negative predictive value compared to other commercially available urine diagnostic tests for bladder cancer.
Gencurix aims to achieve US FDA 510(k) clearance for its GenesWell BCT breast cancer prognostic test next year.
The list includes "high throughput DNA sequence analyzer," "DNA genetic analyzer," and "mass spectrometer for clinical multiplex test systems."
The firm's ROS1 gene fusion kit was approved as a companion diagnostic for Pfizer's Xalkori.
The FDA granted Abbott Emergency Use Authorization for the assay in serum, plasma, and urine in November.
The RealStar Zika Virus RT-PCR Kit 1.0 has been listed by the World Health Organization as eligible for procurement agencies and member states.