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Almac, AstraZeneca CDx Partnership Branching Out to New Disease Areas, Drawing on NGS, qPCR


NEW YORK – Almac Diagnostics' new partnership with AstraZeneca will see the Craigavon, UK-based company draw on its next-generation sequencing and quantitative PCR platforms and deep bench of bioinformatics talent to develop new companion diagnostic assays.

The new tests, once developed, will be used for selecting patients who might best benefit from therapies for kidney disease, nonalcoholic steatohepatitis, and respiratory disease.

Michael Sloan, VP of commercial services for Almac Diagnostic Services, said via email that the firm's companion diagnostics business "has always been a core service" for Almac, and that deals such as the one with AstraZeneca, announced last month, form a significant part of its business.

Sloan noted that companion diagnostics remain an "overarching focus" for Almac, which offers a variety of services around biomarker discovery and clinical trials, as there will always be a need to select which patients will benefit from different treatments.

"Ultimately the end goal will always be to enable biopharma partners to take it all the way through to a companion diagnostic," Sloan said.

Part of the Almac Group, Almac Diagnostic Services has partnered with biopharmaceutical partners for years and has gained experience in developing companion diagnostics for oncology programs. In recent years, though, the number of programs in chronic diseases has increased, and Sloan said that Almac is working as much in those diseases these days as in oncology.

Its technology workhorses have evolved, too. Almac Diagnostics was once heavily invested in microarray technology, and even produced a series of Disease-Specific Arrays (DSAs) focused on different indications and optimized for use on formalin-fixed, paraffin-embedded samples. The arrays were manufactured by Affymetrix, later acquired by Thermo Fisher Scientific.

In recent years though, the company, headquartered about 30 miles southwest of Belfast in Northern Ireland, has turned toward other technologies for its companion diagnostics programs.

"As a company we moved away from microarray technology to focus on qPCR and NGS technologies in line with market changes, advances in clinical practice, and demand," said Sloan.

Sloan acknowledged that DSAs are no longer listed among Almac's platforms on its website. He said instead that next-generation sequencing is a main technology for the company for companion diagnostic development, while he characterized qPCR as "extremely important."

"In chronic disease, for example, qPCR is often the most cost-effective approach for diseases that are associated with relatively few gene variants," said Sloan.

Another perk to using qPCR is that the COVID-19 pandemic prompted laboratories worldwide to invest in new equipment to undertake SARS-CoV-2 testing, Sloan pointed out. That means there is now a significant installed base of qPCR diagnostics instruments basically everywhere, including in local hospital laboratories, systems that can support future companion diagnostics, making the technology a "very attractive option" for such assays.

Almac also works with NanoString's platform in its genomic services business, enabling the firm to develop and optimize assays that range from single-gene and multiplex tests to small-, mid-, and large-sized panels. Genomic services support biomarker discovery and include the aforementioned platforms as well as pathology reviews and clinical support.

The company offers a clinical trial assay service in addition to its companion diagnostics service.

Sloan noted the firm has a seasoned data sciences team with expertise in bioinformatics, biostatistics, and software development, which is part of its offering for biodiscovery, as well as a sample management team.

All of these offerings interlock though, and biomarkers discovered via genomic services can be transited to its clinical trial assay services and be run from Almac's numerous global clinical testing laboratories. The same markers can also find their way into companion diagnostics development. Almac has locations scattered around the world, with a new EU headquarters across the border in County Louth, Ireland, and diagnostics services also based in Durham, North Carolina, and Manchester, UK.

In terms of companion diagnostics, Sloan said the company gives clients like AstraZeneca full-service support, including assistance in the development, manufacturing, and commercialization of such assays. This includes regulatory and clinical support, too, he said. Almac can also offer customers single-site and kitted commercial offerings for their companion diagnostics programs.

According to Sloan, AstraZeneca will draw on all of Almac's services for the new collaboration and the resulting assays will be based both on qPCR and sequencing.

A spokesperson for AstraZeneca, which is headquartered in Cambridge, UK, has annual revenues of $37 billion and employs north of 76,000 people, said that the company's focus on precision medicine led it into an alliance with Almac.

She called precision medicine an "integral part" of the company's R&D efforts and said that more than 90 percent of the company's pipeline now has such an approach.

"Our ambition in biopharmaceuticals R&D is to develop precision medicines for chronic diseases that make it possible to diagnose and intervene earlier," the spokesperson said.

The partnership with Almac is an outcome of this turn toward precision medicine, according to the spokesperson. She reiterated that the duo will work on specific companion diagnostics assays in certain disease areas, including kidney disease, nonalcoholic steatohepatitis, and respiratory disease. These will later be implemented into clinical trials, where they will be used to select patients for participation. Later, the same tests could be slotted into routine clinical practice, the spokesperson added, to support the rollout of numerous new therapies worldwide.

Almac's global sweep helped it secure the new collaboration. The spokesperson said that AstraZeneca selects its partners as part of a "rigorous process ensuring their scientific, regulatory, and commercial capabilities." By partnering with Almac, AstraZeneca aims to deliver tests that can be commercialized to enable access to treatment for chronic diseases in a manner that is "consistent with regulatory requirements, across a range of localities," the spokesperson said.

Such partnerships have paid off for AstraZeneca. The spokesperson noted that AstraZeneca and its partners have delivered more than 50 regulatory approved companion diagnostics to market to date. Such assays have been aligned to targeted medicines and in different regions, she noted.

The company has churned out a series of new companion diagnostics deals in recent months, including an agreement with Biocartis related to non-small cell lung cancer announced in June and another with Amoy Diagnostics related to therapies for breast and prostate cancers in April.

For its part, Almac also has a track record in the companion diagnostics space. In 2019, for instance, the company obtained a CE-IVD mark for a sequencing-based test for selecting molecular eligibility in a cancer drug clinical trial undertaken by Turning Point Therapeutics. The same year, the US Food and Drug Administration granted an investigational device exemption for the same diagnostic assay.

The company inked an agreement in January 2021 with Personal Genome Diagnostics to improve opportunities for clinical trial development and companion diagnostic projects. As part of that deal, Almac and PGDx agreed to provide pharmaceutical clients with access to the latter's PGDx elio tissue complete and PGDX elio plasma resolve assays in combination with Almac's genomic services and molecular diagnostic development expertise.