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Almac Diagnostics Sees 'Significant' Pharma Interest in Cancer Subgroup Typing Test

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NEW YORK (GenomeWeb) — Pharmaceutical companies are jockeying to formulate companion diagnostics strategies that involve a new microarray-based assay developed by Almac Diagnostics, according to the company.

The 63-gene test, dubbed the ALM AADx assay, relies on an expression signature to identify high-grade serous ovarian cancer patients who are likely to have a good prognosis following standard-of-care chemotherapy.

However, those same patients show a worse progression-free and overall survival following the addition of bevacizumab, an angiogenesis inhibitor that Roche markets under the name Avastin and is used to treat various cancers worldwide, including ovarian, kidney, lung, and colorectal.

Craigavon, UK-based Almac discussed its validation of the test at the American Society of Clinical Oncology meeting in Chicago in May, and has since experienced a "significant volume of inquiries from pharma companies seeking to develop companion diagnostics strategies" that would rely on the assay to subgroup patients suffering from numerous cancers, according to a statement released last week.

Almac Medical Director Richard Kennedy attributed pharma's response to the assay to the fact that it identifies a "fundamental biology" underlying the disease.

"What is shown is a fundamental biology just like a HER2, ER, or KRAS status," Kennedy told BioArray News. "These biomarkers are associated with response to many drugs that target these pathways," he said. "Similarly the AADx assay should function as a companion diagnostic for any anti-angiogenic therapy."

In addition to bevacizumab, the US Food and Drug Administration has approved a number of other compounds that have anti-angiogenetic activity, including sorafenib, marketed by Bayer as Nexavar; sunitinib, marketed as Sudent by Pfizer; pazopanib, sold as Votrient by GlaxoSmithKline; and everolimus, marketed as Afinitor by Novartis.

The Almac Group, of which Almac Diagnostics is a business unit, serves many of the world's leading pharma firms as a contract research organization, and the company also manufactures, packages, and distributes those companies' drugs. Kennedy said that Almac could make its new assay available to these clients in the context of these existing relationships.

"Almac [has] business models in place to enable partnerships through either partner IP or utilization of Almac-developed IP," said Kennedy.

Almac is apparently keen to see pharma use its new assay. In its statement last week, Almac said that it is "confident that the test will work both for other anti-angiogenic compounds, functioning in a similar manner, as well as for other cancer types."
But just as the company is responding to pharma interest, it is also advancing its own strategy for the test, with the intention of making it available for ovarian cancer patient subgroup typing sometime next year via its CLIA-compliant laboratory, while it pursues CE-IVD marking in the EU and FDA clearance.

Almac is also validating the test in data sets related to other cancer types, with the aim of making it available for subgroup typing those patients in the future.

"What we have found through our subtyping approach is a fundamental biology associated with angiogenesis and this is not limited to any specific disease, similar to the HER2 example," said Kennedy. "We have already carried out some initial validation of the subtype in other diseases and we have seen this molecular subtype in breast, colorectal, and lung cancer," he said. "Further validation of this is part of our ongoing development plan and we plan on validating its utility as a predictive marker for anti-angiogenic agents in these diseases in the next six months."

When Almac launches the assay for clinical use, it will be the first array-based test developed and sold by the company. The company has developed two tests using microarrays that have made it to the clinical market though.

In January, Almac announced that its partner Precision Therapeutics had validated ColDx, the company's 634-gene-signature test for stage II colorectal cancer recurrence, ahead of a planned US launch under the name GeneFX Colon.

Almac has also licensed to Genomic Health a 44-gene-signature test for breast cancer chemotherapy response. Genomic Health plans to make the test available using quantitative PCR and Kennedy said that Almac is working with Genomic Health to "bring the assay forward into the clinic."

Almac developed all of these tests using its menu of Disease Specific Arrays, or DSAs, for breast, ovarian, colorectal, lung, and prostate cancer. Each of the Affymetrix-manufactured chips contains about 60,000 transcripts associated with a particular disease. The firm has also developed a more generic, cancer-focused array called Xcel that Affymetrix distributes globally as a catalog chip.

Like those other chips, the array that is used in Almac's AADx assay is manufactured by Santa Clara, Calif.-based Affymetrix.

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