PERTH, Australia – Sydney-based Speedx Pty. Ltd. has signed a global distribution deal with Roche AG, through which the latter will sell Speedx’s Resistanceplus MG and Resistanceplus GC molecular tests for detecting antimicrobial resistance to Mycoplasma genitalium (Mgen) and gonorrhea, respectively.

Under the terms of the agreement, Roche will have nonexclusive access to Speedx’s real-time polymerase chain reaction (qPCR) tests to enable a global reach and expansion of its diagnostic products for managing antibiotic resistance in sexually transmitted infections.

“From a win-win perspective, [Roche] is able to supplement its offering in STDs [sexually transmitted diseases], and we’re able to maximize our distribution network with their already established links in a lot of geographical regions,” Speedx CEO Colin Denver told BioWorld.

The two will collaborate on marketing, and Roche will use its direct sales force to promote Speedx’s products. Denver said Speedx will sell the products to its partner at a transfer price, and then Roche will have its own retail price.

Colin Denver, CEO of Speedx Pty. Ltd.

Because it’s a global deal, it’s a “blue sky opportunity right now,” Denver said, adding that the MG test is considered a new indication in many markets.

“Our innovative diagnostic tests go beyond simple pathogen detection and support resistance-guided therapy, providing information on antibiotic resistance to empower clinicians with the information they need to make appropriate treatment decisions.”

As antibiotic resistance rises, these new diagnostics can help clinicians choose the best targeted therapy for individual patients based on the resistance status of their infection. This helps conserve certain treatment options to better control the spread of resistant infections.

Gonorrhea and Mgen are listed by the CDC as key threats, and that’s due to the concerning rise of antibiotic resistance and the limited availability of treatment options. Formal disease management guidelines around the world now focus on the use of resistance-identifying diagnostics to help inform treatment and conserve the use of current antibiotics.

Speedx’s Resistanceplus GC gained breakthrough device designation from the U.S. FDA in June 2019. The molecular test provided ciprofloxacin susceptibility and resistance information to treat N. gonorrhea.

The test already has received the CE mark and has been cleared by Australia’s Therapeutic Goods Administration (TGA). It detects both N. gonorrhea and sequences in the gyrA gene of the bacteria associated with susceptibility or resistance to ciprofloxacin, a previously used frontline antibiotic treatment.

New Australian and European guidelines on managing STDs are driving demand for Speedx’s Resistanceplus MG diagnostic that simultaneously detects the Mgen bacteria and the genetic markers linked to antimicrobial resistance.

"We've seen guidelines for STD management changing globally that are driving adoption of the MG test," Denver said. "Guidelines recommend at the time of diagnosis that patients are tested for the presence of MG, as well as antibiotic resistance, and, in Australia, we are the only TGA-approved option."

A rapid rise in resistant strains of Mgen has led to new international guidelines that recommend testing for macrolide resistance to better inform treatment options.

MG is more prevalent than gonorrhea and causes urethritis, cervicitis and pelvic inflammatory disease, which can lead to serious health complications, including infertility. The bacteria are developing resistance to azithromycin rapidly, with recent studies showing up to 50% of MG-positive patients harboring resistant strains, Denver said.

"We found it's been around for a long time, but because you couldn't culture the bacteria, people didn't know it was there. But now the DNA can be amplified to detect MG."

New COVID-19 test in the works

The company has an influenza multiplex test in development that screens for respiratory syncytial virus (RSV) and other respiratory viral pathogens. That test has been available in the last year, Denver said, and Speedx is getting ready to launch a COVID-19 test. The latter is going through the final testing before a submission to the TGA for an emergency use exemption. He expects that to go through in September at the latest.

“Although we’re not the first company to launch such a test for coronavirus, one of the advantages we’ve had in coming a little later than some of the others is that we’re now basing our designs on [more than] 24,000 genetic sequences that have been uploaded to the database.

“We feel confident with the targets we’ve been able to develop for the coronavirus, and we see that the addition of this into a workflow that includes flu, RSV and other viral targets is the way this is going to go moving forward. Having the flexibility for a lab to run coronavirus on its own or as part of that wider solution is really important moving forward, and we’re in a good position to supply that now.”

Speedx recently inked a distribution deal with Thermo Fisher to bring the Resistanceplus MG test to the U.S. It also signed an agreement with Cepheid to distribute its PlexPCR and Resistanceplus tests in Europe.

Earlier this year, it announced a partnership with Laboratory Corp. of America Holdings in the U.S. to support development activities for infectious diseases.

In August 2019, the private company reported $15 million in series A funding from new U.S. investor, Northpond Ventures. Northpond invested an additional $15 million in a series B round in January.

“We’re in a good spot,” said Denver. “We have nice distribution, money in the bank, and the tests will create positive change.”

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