Novacyt Regulatory News (NCYT)

NOVACYT EXPANDS DEVELOPMENT PARTNERSHIP

WITH IMMUNEXPRESS

Extension of contract continues multi-year assay

design and development program

Paris, France and Camberley, UK - 8 April 2019 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, today announces its molecular testing division, Primerdesign Ltd. (Primerdesign), has expanded its assay development contract with Immunexpress, Inc. (Immunexpress), a U.S.-based molecular diagnostic company with the first FDA cleared host response test for suspected sepsis patients, to further support the development of rapid diagnostic assays for the detection of sepsis.

Primerdesign has been working in partnership with Immunexpress for over three years. This expansion reaffirms Immunexpress's confidence in Primerdesign's development capabilities and highlights the division's pivotal role in assay development as it grows its relationships with leading diagnostics companies.

Sepsis is a potentially life-threatening complication in which a person's immune system inappropriately responds to an infection by triggering a broader inflammatory response, which could cause damage to multiple organs and ultimately lead to death. Left undiagnosed or untreated, a patient could die within a matter of hours.

Early diagnosis of sepsis is a serious and challenging health care issue, which the Centre for Disease Control (CDC) estimates affects 1.7m people in the US per year and is responsible for 270,000 deaths. Annually, sepsis affects an estimated 27-30 million people worldwide2 and represents a major unmet medical need. Sepsis is the most expensive condition treated in U.S. hospitals3 with a mean cost per severe sepsis patient of $US 24,638. Similar mean hospital costs per patient for sepsis have been determined in Europe ($US 37,424)4. In the U.S., between 2005 and 2014, the total annual cost of sepsis hospitalization increased from $22.2B to $38.1B5. 

Rolland Carlson, PhD, CEO of Immunexpress, commented:

"Our continued partnership with Novacyt supports our joint efforts to deliver multiplexed assays that improve the management and clinical outcomes of sepsis patients around the world. We are committed to developing diagnostic tests to enable clinicians to manage patients with sepsis or suspected sepsis and we have been impressed with Primerdesign's ability to rapidly develop assays and their track record of CE marking diagnostic tests in a timely manner."

Graham Mullis, Group CEO of Novacyt, added:

"I am delighted that we are entering into our sixth agreement with Immunexpress to aid clinicians in patient management with sepsis. This contract expansion adds further momentum to our business-to-business segment and provides further validation of the expertise our clinical assay development service offers.

"I am pleased with the team's progress converting a rich pipeline of business-to-business opportunities into commercial contracts. We aim to become the development partner of choice for molecular diagnostic companies who wish to efficiently deliver complex multiplexed assays."

Financial terms of the agreement have not been disclosed.

[1] https://www.cdc.gov/sepsis/datareports/index.html

2 World Sepsis Day Factsheet 2018, available at https://www.worldsepsisday.org/sepsis. .

3 C. Paoli, et al. Epidemiology and Costs of Sepsis in the United States - An Analysis Based on Timing of Diagnosis and Severity Level, Critical Care Medicine 2018; 46: 1889-1897.

4 H. Arefian, et al., Hospital-related cost of sepsis: A systematic review, Journal of Infection, 1-11 (2016).

5 M. Rubens, et al., Increasing Sepsis Rates in the United States: Results From National Inpatient Sample, 2005 to 2014, J Intensive Care Med, 885066618794136 (2018).

- End -

Contacts

Novacyt SA

Graham Mullis, Chief Executive Officer

Anthony Dyer, Chief Financial Officer

+44 (0)1223 395472

Stifel Nicolaus Europe Limited (Nominated Advisor and Joint Broker)

Jonathan Senior / Fred Walsh / Ben Maddison

+44 (0)20 7610 7600

WG Partners (Joint Broker)

Nigel Birks / Chris Lee / Claes Spång

+44 (0) 203 705 9330

FTI Consulting (International)

Brett Pollard / Victoria Foster Mitchell

+44 (0)20 3727 1000

brett.pollard@fticonsulting.com / victoria.fostermitchell@fticonsulting.com 

FTI Consulting (France)

Arnaud de Cheffontaines / Astrid Villette

+33 (0)147 03 69 47 / +33 (0)147 03 69 51

arnaud.decheffontaines@fticonsulting.com / astrid.villette@fticonsulting.com

About Novacyt Group

The Novacyt Group is a rapidly growing, international diagnostics business generating an increasing portfolio of in vitro and molecular diagnostic tests. Its core strengths lie in diagnostics product development, commercialisation, contract design and manufacturing. The Company's lead business units comprise of Primerdesign and Lab21 Products, supplying an extensive range of high quality assays and reagents worldwide. The Group directly serves oncology, microbiology, haematology and serology markets as do its global partners, which include major corporates.

For more information please refer to the website: www.novacyt.com 

About Immunexpress Inc.

Immunexpress is a Seattle-based molecular diagnostic company committed to improving outcomes for patients suspected of sepsis. Immunexpress' SeptiCyte™ technology rapidly quantifies, directly from whole blood, specific molecular markers from the patient's own immune system - the 'host response'. SeptiCyte™ LAB, recently cleared by the FDA, is the first of its kind in using the host immune system to differentiate systemic inflammatory response syndrome (SIRS) and sepsis. Detecting the host's response to infection has the potential to differentiate infection earlier, faster and more accurately than finding the invading pathogen because it is independent of whether or not the pathogen is present in the sample. Immunexpress' pipeline includes several sample-to-answer assays for near patient testing. For more information visit http://www.immunexpress.com/.

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