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Genedrive Expects CE-IVD Mark for POC SARS-CoV-2 Test by Fall; Advances Hearing Loss, HCV Assays

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NEW YORK — Even as it has its eye on launching a test for SARS-CoV-2, Genedrive is circling back to its legacy business.

Genedrive aims to have a point-of-care molecular test for SARS-CoV-2 on the European clinical market within the next few months, according to its CEO David Budd. And while the COVID-19 pandemic has drawn its attention, as it has done for most firms in the molecular diagnostics space, Genedrive is renewing its focus on other tests in its menu, he added.

The Manchester, UK-based company had previously planned to have a CE-IVD marked point-of-care SARS-CoV-2 test out by June 30 but informed shareholders earlier this month that it would miss that deadline, citing a "longer than anticipated development time."

"Since we missed the deadline, we had to update the market on our progress," Budd remarked. "It was a line we had previously drawn in the sand."

In its statement, Genedrive noted "significant technical hurdles" in the test's development, as well as its desire to improve the performance specifications of the platform, as the requirements of the SARS-CoV-2 testing market have been evolving, especially related to sensitivity, specificity, speed, ease of use, and scalability.

"In developing these things, half of it is biological, so it's not like building a house where you can buy some timber, screws, and assemble it," commented Budd. "Stuff happens that you don't always have control over, but we managed to do away with a lot of the uncertainty upfront," he said. Budd also noted that there have been scientific advances related to direct PCR that have allowed the company to improve its workflow as it prepares the product for a CE-IVD mark.

Genedrive's test relies on a nasopharyngeal swab as a sample source, and Budd said that Genedrive developed a proprietary lysis buffer to deliver biosafety to the product both before and after the swab is used. Public Health England is currently assessing the biosafety of the method.

The firm's handheld eponymous instrument includes a PCR thermocycling device that provides rapid nucleic acid amplification and detection results and allows users to detect SARS-CoV-2-positive samples in about 10 minutes, with negatives reported after 20 minutes if no signal is detected. The system fits in a user's palm, is 12 cm by 18 cm by 10 cm, and weighs 600 grams, Budd said. The list price for the system is less than $3,000 and normally offered as part of a reagent rental package, he added.

The test targets two genes, N and ORF1ab, in the SARS-CoV-2 genome, and is inclusive of all variants of concern, including the delta variant. An internal validation study found 100 percent concordance with 30 positive and 30 negative samples tested originally with real-time PCR.

The four-step workflow relies on an eye dropper liquid transfer process so that non-technicians can run the test. The company is currently targeting a late September or early October date for achieving a CE-IVD mark. Budd did not think the delay would significantly impact Genedrive's opportunities.

"We are about three months behind," Budd said. "In the good old days pre-COVID, development cycles of these things were three years and now people do them in months," he said. "It's pretty amazing what we have done and pretty amazing what other companies are doing nowadays compared to what they did a few years ago in terms of life cycle."

The market has changed recently, though, as efforts to track and contain SARS-CoV-2 have shifted in some countries from mass testing to more targeted needs, a trend that Budd believes favors adoption of Genedrive's point-of-care offering.

"Curiously, as vaccines are rolled out, and the incidence of COVID-19 declines, the market for our system becomes bigger," commented Budd. "We just spent the last year and a half trying to screen thousands of people a day, but that is not where the market is going," he said. Instead, targeted, rapid testing done at airports, or in offices, will become more of the norm, Budd said.

"Travel was a [nonexistent] market segment a year and a half ago," noted Budd. "And in the workplace, you can imagine, say, C-suite executives as wanting to have access to highly accurate tests."

Genedrive sees its test and instrument as being ideal for such use cases. Budd noted the instrument's tight build, making it both low cost to manufacture and easy to ship worldwide. "You don't need an engineer to come in and install it," he pointed out.

Genedrive is not the only firm that sees an opportunity in delivering point-of-care platforms for SARS-CoV-2 testing. MatMaCorp, Nuclein, GNA Biosolutions, Cepheid, and Mesa Biotech are just a few of the companies working to serve the market.

During the pandemic, Genedrive has also sought to serve the screening market and partnered with Danaher's Beckman Coulter Life Sciences to offer a 96-plex PCR assay on Beckman's Biomek i7 automated workstation. While the company was able to secure a CE-IVD mark for the test, called the Genedrive 96 Sars-CoV-2 Kit, its application for an emergency use authorization in the US is still pending. Budd noted that Genedrive got approval from Indian regulators a month and a half ago. He described the US and India as the two main markets for the assay.

"There is certainly opportunity there," said Budd about India, "but the challenge is pricing. The reimbursement per test in the US is a magnitude higher than it is in India." He noted the ability to run assays on Genedrive's battery-powered system using non-refrigerated reagents, which without a need for air conditioning, make it ideal for use in rugged settings such as India.

As noted, Genedrive expects the market to gradually shift from high-throughput screening assays to more targeted testing in the future. Budd said that the opportunities in the COVID-19 testing market are "very political and geographic" and differ based on how authorities are managing the crisis in each country.

"When it all started it was impossible to say if this would last a year or be a forever market," said Budd. "It is at least a medium- and long-term market," he said. "I think as countries get vaccinated the dynamics of testing will change from mass screening to targeted, lower throughput."

While Europe has been a core market for Genedrive, the company has distribution partners in place to reach other regions. It is also actively engaging for new partners, especially in the US.

"The US remains an attractive market, with good reimbursement levels and more private-based opportunities than exist in many other markets," said Budd. "The opportunities for point-of-care testing extend beyond healthcare, and include travel, education, and occupational health settings," he said.

Hearing loss and HCV

Genedrive has been developing a point-of-care test for antibiotic-related hearing loss for almost three years. Its assay, developed in partnership with the Manchester Center for Genomic Medicine, can be used to detect a genetic mutation in the MT-RNR1 gene that can cause hearing loss in some newborns who have taken gentamicin, an antibiotic prescribed for various bacterial infections. The test has a turnaround time of about 30 minutes.

Genedrive achieved a CE-IVD mark for the test, called the Genedrive MT-RNR1 kit, in 2019. Last year, the UK National Institute for Health Research Manchester Biomedical Research Centre embarked on a clinical trial of the test involving around 800 newborns from sites in Manchester and Liverpool to evaluate its implementation in an NHS setting.

Budd said that Genedrive spent most of 2020 involved in the trial to see if its test could be run while admitting an infant to the hospital without delaying the admission process. "The answer was yes," he noted. "You can get genetic information on a baby that doesn't impact admission."

A manuscript is being written at the moment, and Genedrive now plans a commercial launch of the test in the fall. Based on feedback from users, Genedrive is also improving the instrument interface to better address their needs, Budd said.

Genedrive obtained a CE-IVD mark for its hepatitis C virus assay in 2017 and partnered with Sysmex to sell the assay throughout Europe, the Middle East, Africa, and the Asia Pacific region. Last year, the World Health Organization included the assay in its list of prequalified diagnostics, making it eligible to be included in United Nations agencies' procurement processes.

Budd described the company's HCV test as its business area most impacted by the COVID-19 pandemic.

"HCV is a chronic disease. You can have it for 15 years and not have any symptoms at all," said Budd. "When the world was focusing on COVID, chronic disease was left to the side," he said. 

Despite this temporary setback, Budd said sales have resumed in Africa and Asia Pacific, which he described as the primary markets for the test. "We see more activity picking up, and I think we can feel positive that it's turned around," he said. 

And while the pandemic has arguably diminished HCV assay sales, Budd said that overall, there have been benefits for the molecular diagnostics industry in terms of raising its public profile.

"People are sitting on buses talking about getting PCR tests done," said Budd. "Who would have ever thought that would happen?" he said. "From an industry visibility standpoint, it's been amazing."

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