This article has been updated to clarify that Guardant Health's CE mark was only for the sample collection process of its test.
NEW YORK (GenomeWeb) – Guardant Health has partnered with Labco Quality Diagnostics, which is part of Synlab Group, to distribute its Guardant360 test in some European and South American countries, beginning first with Spain, the company said today.
Labco will serve as the exclusive sales, reimbursement, and distribution partner for the next-generation sequencing-based pan-cancer liquid biopsy assay in selected countries, and as a non-exclusive distributor in other countries it covers.
Guardant Health CEO Helmy Eltoukhy told GenomeWeb that the agreement with Labco covers several countries in both Europe and South America, but the firm will launch "in a staged way" beginning first with Spain. Eltoukhy said that Labco made a good partner for Guardant Health because it is not only one of the largest international test distributors, but also because Labco would be more than just a distributor, working with payors in other countries to help secure reimbursement for the test.
In addition, the firm said that it received the CE mark for the sample collection portion of its test, which involves a blood draw. That allows it to distribute in European countries and run the assay from its CLIA-certified, CAP-accredited Redwood City, California laboratory.
Eltoukhy declined to disclose whether the company would eventually look to market the assay as a kit or to license out its technology so that laboratories could run assays themselves. For now, the company will continue to provide Guardant360 as a service. Shipping samples internationally has been "surprisingly very efficient," and typically takes around 48 hours, sometimes 24 hours, Eltoukhy said.
Eltoukhy said the firm is also considering bringing the test through US Food and Drug Administration clearance. Aside from selling the liquid biopsy test to oncologists to make treatment decisions for their patients, Eltoukhy said that the firm has seen a lot of interest from pharmaceutical companies that are interested in developing a liquid biopsy test as a companion diagnostic, although he declined to elaborate. For that purpose, the test would need to be brought through FDA clearance, he said.
The firm also is collaborating with the National Cancer Institute-funded SWOG cancer research consortium on a prospective study to use the Guardant360 assay to identify mechanisms of resistance and potential treatment options in non-small cell lung cancer patients.
In the clinical space, Eltoukhy said the company has seen a lot of interest from oncologists and patients for Guardant360, particularly for later-stage patients, for whom performing a tissue biopsy may be difficult or just too costly and invasive, and even for some early-stage patients for whom a tissue biopsy has failed.
The test can be run on patients with any tumor type, although Eltoukhy said the "sweet spots" were lung, colorectal, breast, and melanoma tumors, since they have well-validated actionable alterations.
Eltoukhy said that the firm is in discussions with various payors about reimbursement, but so far, both US and international patients are primarily paying the $5,400 list price out of pocket.
Guardant Health first launched Guardant360 in 2014, and earlier this year published clinical validation data demonstrating the test had a specificity of 99.9999 percent and a sensitivity of 100 percent when compared with tissue sequencing results. In addition, it showed that of its first 1,000 commercial patients, the vast majority had an actionable result.