Qiagen gained approval for its companion diagnostic for Erbitux and Vectibix (a therascreen® KRAS genetic test) in July, making it reportedly the only FDA-approved KRAS test for use in metastatic colorectal cancer patients.
According to Weinstein, “Qiagen is getting in front of the curve. It’s partnered with approximately 20 companies and has one of the largest programs, with a focus on oncology.”
It acquired Intelligent Bio-Systems recently, Cellestis in 2011, and a significant portion of Ipsogen. The company also has long-established relationships with research labs that help it tailor solutions to specific needs. Those many partnerships also protect Qiagen from being an acquisition target, Weinstein says.
“There’s no independent diagnostic company with the breadth and depth of Qiagen,” Weinstein continues. By leveraging its position in genetic testing sample preparation, it stabilizes cash flow, which enables it to target higher risks and rewards.
He expects companion diagnostics to contribute approximately $100 million this year to the company’s $1 billion revenues. Its diagnostics revenues are likely to be divided evenly among research use only, contract research revenues, and CE Mark sales. In the second quarter of 2012, Qiagen reported a 9% increase in sales from the same period one year ago. Weinstein estimates Qiagen will generate adjusted earnings per share of $1.14 in 2012.
Genomic Health has a pipeline tightly focused around oncology. Tests already are commercialized for breast and colon cancer, and assays for additional markers involved in those diseases are in development. They include assays to validate mismatch repair status and to identify targeted therapy benefits in colon cancer; to determine the relative benefit of chemotherapy administered with various therapies for breast cancer; and to estimate the post-surgical recurrence risk for renal cancer.
An assay to guide the choice among active surveillance, radiation, or surgery for early-stage prostate cancer is at the clinical validation stage. Assays for melanoma and for non-small-cell lung cancer are in early development.
Product revenue for the six months ended June 30, 2012, was $115.1 million, compared with $100 million for the six months ended June 30, 2011, an increase of 15%. The financial guidance for the full year ending December 31, 2012, projects total revenue between $230 and $240 million and net income between $5 and $8 million before losses.
Foundation Medicine also is centered around cancer diagnostics. In August it announced a collaboration with Clovis Oncology to develop an in vitro diagnostic assay to identify biomarkers to identify the ovarian cancer patients most likely to benefit from rucaparib, Clovis’ poly ADP-ribose polymerase inhibitor now in Phase I/II development.
The goal of the collaboration is to expand the known mutations that are associated with defective DNA repair and thus identify appropriate tumor targets. Foundation Medicine also is working with the Worldwide Innovative Networking Consortium and with Novartis to provide broad genomic information for clinical programs.
Life Technologies is also entering the companion diagnostics space. As O’Bryan says, “Life Technologies has taken initiative to convert its technology for clinical testing.”
It also is beginning to develop genetic assays, acquiring Navigenics and Pinpoint Genetics in the past year. The plan, O’Bryan says, is to validate Life’s products into FDA-approved diagnostic kits.
Life also is working with GSK to develop a qPCR-based molecular diagnostic assay for GSK’s MAGE-A3 cancer immunotherapy candidate—currently in late-stage trials—to identify patients likely to benefit.
“Recently, Life talked about taking technologies into CLIA labs, and has approached Quest Diagnostics and LabCorp,” O’Bryan adds.
Overall, Life Technologies reported a 1% growth for the second quarter of 2012, compared to the same period one year ago. Revenue from its genetic analysis business was $353 million, down 6% from the second quarter of 2011 as customers transitioned between instrument platforms. Excluding their impact, genetic analysis revenues increased 5%.
Roche Molecular Diagnostics also has “an enormous diagnostic franchise in-house,” Weinstein adds. Other companies with smaller initiatives include GenMark Diagnostics, Nanosphere, Novartis and perhaps 100 others.