Big news has been announced by genedrive (LON:GDR) this morning and it has got the group’s shares on the run higher – some 33% up at 3.70p in the first couple of hours trading.
The £20m capitalised company is the Manchester-based ‘point-of-care’ pharmacogenetic testing company for use in emergency healthcare.
Its Kits
It is developing and commercialising a low-cost, rapid, versatile and simple to use point of need pharmacogenetic platform for the diagnosis of genetic variants.
This helps clinicians quickly access key genetic information that will aid them make the right choices over the right medicine or dosage for an effective treatment, which is particularly important in time-critical emergency care healthcare paradigms.
The Genedrive® MT-RNR1 ID Kit is a worlds-first and allows clinicians to decide on antibiotic use in neonatal intensive care units within 26 minutes, ensuring vital care is delivered, avoiding adverse effects potentially otherwise encountered and with no negative impact on the patient care pathway.
Its CYP2C19 ID Kit, which has no comparably positioned competitor, currently allows clinicians to decide on the use of Clopidogrel in stroke patients in 70 minutes, ensuring that patients who are unlikely to benefit from or suffer adverse effects from Clopidogrel receive an alternative antiplatelet therapeutic promptly, ultimately improving outcomes.
Breakthrough Device Designation By U.S. FDA
This morning the group announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration for the Genedrive® MT-RNR1 ID Kit.
CEO James Cheek stated that:
“We are delighted to receive FDA designation of our MT-RNR1 point of care pharmacogenetic test and corresponding recognition of the potential benefits to U.S. patients.
The U.S. is an attractive market for this unique test given the potential to save hundreds of individuals from life-long deafness and reduce litigation costs relating to the unwanted side effects from antibiotic use on those carrying the gene variant, and given its size, birth rates, use of diagnostic testing and reimbursement structure.
The FDA Breakthrough Device Designation process will be invaluable in mitigating study design risks associated with bringing a novel test such as this to the U.S. market where no predicate device exists with which to align study designs to.
Together with our in-place partnership with a multi-state physician led clinical partner with neonatal services expertise covering the majority of U.S. states we look forward to affordable, collaborative and timely progress through the FDA De novo process.”
Today’s news has seen a substantial increase in trading of the group’s shares, with some 82m dealt within the first two hours.