The Company is an immuno-diagnostics development company, initially focused on the kidney transplantation market. The Company’s kidney transplant assays use advanced next-generation sequencing that may define a personalised, risk-profile of each patient over the course of their transplant journey, as well as may detect injury in advance of currently available clinical tests.
The Company develops tests to understand how a patient is likely and may be responding to organ transplant. The Company’s products and solutions are underpinned by extensive scientific research into how the recipient’s immune phenotype is likely to respond to the transplanted organ and how that response further influences acute rejection, chronic injury and, ultimately, failure of the transplant.
There are two leading products for clinical validation and commercialisation:
These products are planned to be offered as laboratory developed tests (“LDT”) in the US, taking advantage of the lighter regulatory burden of authorisation under the CLIA regime which is administered by CMS, in partnership with state health departments, rather than seeking clearance from the FDA.
In Europe the company will be seeking CE marking. CE marking issued by an EEA Notified Body will remain valid in the UK market until 30 June 2023. To address the UK market post-Brexit, the company will be seeking for UKCA (UK Conformity Assessed) mark as well. In addition to obtaining CE and UKCA markings, the products (the devices) will be registered with MHRA as required by MHRA after 1 January 2021.
The Company is planning on complementing this commercial path with an efficient route through reimbursement coding, pricing and coverage determinations in the US. For inclusion into NICE guidelines in the UK, evidence-based data (such as health economic cost-effectiveness and patient outcome/clinical-effectiveness data, along with diagnostic test accuracy data), shall be applied for review by NICE Diagnostic Assessment Programme.