Agenix's D-dimer diagnostics get boost from international studies

Two studies published recently in leading medical research journals have given ticks to the SimpliRED and Simplify blood-clot diagnostics developed by Brisbane biotech Agenix (ASX: AGX, NASDAQ: AGXLY)

The New England Journal of Medicine reported on a multi-hospital, 1000-patient study of the SimpliRED in vitro test developed and marketed by Agenix subsidiary AGEN Biomedical, which found the test was safe, accurate and cost-effective in screening patients suspected of having blood clots.

The SimpliRED test detects the D-dimer molecule that appears in the bloodstream as the body attempts to break down a clot.

The NEJM reported that the differential-diagnosis test excluded 39 per cent of patients who might otherwise have undergone time-consuming and expensive clot-imaging procedures.

Another paper, published in Annals of Emergency Medicine, discussed the problems confronting faced by emergency-ward clinicians in diagnosing blood clots and administering clot-dissolving therapy in a timely and cost-effective manner.

It proposes a diagnostic pathway for blood clots, based on AGEN's SimpliRED and Simplify D-dimer tests.

Agenix MD Don Home said the company's D-dimer assays had already been validated by extensive clinical trials in the US and Canada. "Clinicians now have powerful statistical confirmation that D-dimer, with clinical assessment and risk analysis, can safely exclude [a diagnosis of] blood clots in veins."

"... the combination of clinical assessment of patients with a proven clinical model, combined with a negative D-dimer result, safely excludes patients with suspected deep-vein thrombosis (DVT)," said the co-author on the papers, Dr Philip Wells, chief of the division of haematology and Canada Research Chair at Ottawa Hospital.

Agenix says DVT is a common, extremely painful and potentially life threatening condition if undiagnosed. Accurate and early diagnosis of a clot, minimizes the risk of complications, and for patients who turn out not to have clots, avoids exposure to the risks of anticoagulant therapy.