Genomic Health Targets European Cancer IVD Marketplace With Biocartis Deal

ROCKVILLE, Md., Sept. 18, 2017 /PRNewswire/ -- At least one market research firm thinks that Genomic Health's deal with Biocartis may not only assist the company with reaching European markets past competitors, but also foster a trend in the IVD market. Genomic Health announced on September 13th that they have entered into an exclusive agreement under which they will develop an in vitro diagnostic version of Genomic Health's Oncotype DX breast cancer test on Biocartis' Idylla platform. Kalorama Information, a market research firm with a specialty in in vitro diagnostic market, has predicted in the past that companies may convert lab-developed tests (LDTs), performed at the company-owned laboratory, into in vitro diagnostic products that are sold to laboratories to perform themselves. Kalorama Information has covered the LDT market in its report The World Market for Molecular Diagnostics.

Under the terms of the agreement, Genomic Health will gain exclusive worldwide rights to develop and commercialize its Oncotype DX Breast Recurrence Score test on Biocartis's Idylla platform, with the option to expand the collaboration to include additional tests in oncology and urology. Unlike Genomic Health's current laboratory developed tests, which users have to send out to the company's central lab, the new IVD would allow customers to perform the Oncotype DX assay locally in their own facilities.

"Molecular point-of-care technology is key here," said Bruce Carlson, Publisher of Kalorama Information.  "Advanced cancer testing labs have begun establishing operations in the European market and found rapid growth in the region, but there is competition and in moving to an IVD platform, it's a way to bring their test technology to new customers that aren't accustomed to the IVD company-owned lab model."

The Oncotype DX Breast Recurrence Score measures the activity of 21 genes in patients' tumor tissue, providing a score that indicates risk of recurrence and helping to guide decisions about whether to use adjuvant treatment. Biocartis' Idylla platform provides a fully automated sample-to-answer, real-time PCR cartridge system Genomic Health intends to enable local pathology labs to generate Oncotype DX Breast Recurrence Score results with minimal labor, efficient turnaround time, and the consistent high quality and clinical utility that physicians and patients have come to expect when making treatment decisions with Oncotype DX.

Genomic Health will make a payment of approximately $3.3 million to Biocartis as part of the agreement. Media reports indicate that Genomic Health's plan is to launch the breast cancer IVD in Europe, beginning with France and Germany in 2019.  

Kalorama notes that company-owned test service business model is primarily a phenomenon of the U.S., where there is a long history for the commercialization of highly specific assays as test services. U.S. reference labs were first to launch many groundbreaking tests in the areas of viral load testing, anatomical pathology special analyses and molecular assays. This sensitized the medical community to the value of these test services. Competition is intense for such tests in the European market. Although Genomic Health has made progress in gaining payment for the LDT version of Oncotype DX internationally, having a product more suited for Europe's decentralized lab model may help it compete more aggressively with other assays like Nanostring's Prosigna and Myriad Genetics' EndoPredict. NanoString Technologies' Prosigna Gene Signature Assay and nCounter Dx Analysis System was provided a positive assessment by Blue Cross Blue Shield (BCBS) Evidence Street in January 2017. The organization under BCBS uses scientific criteria and clinical evidence to assess medical technologies.  

"Lab-developed test to IVD conversion is a trend that Kalorama has predicted in some of our past studies, though I suspect that in the U.S., the laboratory-developed test is here to stay," Carlson said.

The test service model has become a major route for highly sophisticated and specialized tests. The most successful company owned test services involve anatomical pathology (histology/cytology) and molecular assays, primarily in situ hybridization (ISH) and PCR analysis of biopsied tissue for cancer analysis  The U.S. FDA's attempted implementation of an LDT approval process on par with IVD is postponed indefinitely following industry and political backlash at regulatory expansion.  

About Kalorama Information

Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.

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SOURCE Kalorama Information