Novacyt launches new 'Winterplex' test, lateral flow tests delayed

Clinical diagnostics specialist Novacyt issued a research and development update on Thursday, including the launch of a new CE-marked ‘Winterplex’ polymerase chain reaction (PCR) test to diagnose Covid-19, respiratory syncytial virus (RSV) and types of influenza.

The AIM-traded firm also announced the launch of a new CE-marked ‘Escapeplex’ PCR test to diagnose four key Covid-19 variants, as well as the development of ‘CO-Prep’ to further automate and streamline the workflow process of its near-patient ‘PROmate’ test.

It also updated shareholders on its ‘PathFLOW’ lateral flow test (LFT) portfolio.

The company said that as the northern hemisphere approached the 2021-2022 flu season, Novacyt had carried out an analysis of recent influenza genome sequences using its specialist bioinformatics surveillance expertise to determine how significant the genetic drift was in the virus from the previous year.

Through that analysis, it said it had detected “significant” mutations in published sequences of the influenza B virus, and developed a new Winterplex test to address the new strain for the 2021-2022 winter flu season.

The new test combined flu B, three-gene Covid-19, flu A and RSV assays in a single kit, to provide clinicians and laboratories with a comprehensive testing solution.

Novacyt said the test was designed for use in central laboratories with open PCR platforms.

Additionally, the company said that following the successful launch of Escapeplex as a research-use-only (RUO) test in April, it had launched a CE-mark version of the test to meet demand for clinical use.

Escapeplex included gene targets for four key mutations, or ‘variants of concern’, of SARS-CoV-2, enabling clinicians and laboratories to detect the most significant virus variants in a single kit.

The test identified four escape mutations known to be associated with the most significant variants, with Escapeplex also designed to be used in central laboratories with open PCR platforms.

In line with the company's strategy to build on its capabilities in near-patient testing through improved workflow solutions, Novacyt said it had also co-developed CO-Prep, which it described as an instrument for sample handling automation.

CO-Prep was designed to automate the liquid handling steps of the company's near-patient PROmate test.

The workflow included a small footprint for use on benchtops or in containment hoods, and as a result, CO-Prep would offer laboratories increased capacity, automation of repetitive manual pipetting, increased accuracy, reduction in intra-sample contamination risk, and time for technicians to concentrate on other work.

Finally, and in addition to the announcement on 29 June, the company confirmed there was a delay in the launch of PathFlow Covid-19 Rapid Antigen, a self-LFT to detect SARS-CoV-2 antigens, previously expected in the third quarter.

It said the delay was due to increased demand for self-test approvals causing a backlog of tests currently under review by its notified body.

The notified body had communicated a delay of up to six months, and thus it was also evaluating other approved options for a Covid-19 -19 self-LFT.

Its PathFlow SARS-CoV-2 SMART IgG LFT, expected to launch in the third quarter, was also delayed.

That was due to the company's partner being unable to secure sufficient supplies for Novacyt to launch the test.

Novacyt was thus evaluating additional LFT options to detect and differentiate between SARS-CoV-2 IgG antibodies.

“The launch of two new CE-marked tests, Winterplex and Escapeplex, to address the approaching winter flu season in the northern hemisphere and key mutations of Covid-19 in a single kit, respectively, reinforces Novacyt's ability to address evolving needs in the diagnostics market,” said chief executive officer Graham Mullis.

“Novacyt's continued focus on innovation is demonstrated by the development of CO-Prep to provide further workflow solutions for clinicians and laboratories testing for Covid-19.

“This automated instrument technology can also be leveraged for future disease areas to support the company's growth beyond Covid-19.”

At 0919 BST, shares in Novacyt were down 2.09% at 280.61p.