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MDx/CDx Focus: Verastem, LabCorp Ink CDx Pact; Foundation Medicine Raises More Cash; and more

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Verastem, LabCorp Collaborate to Personalize Mesothelioma Drug

Verastem and the Laboratory Corporation of America announced they were working together to validate biomarkers associated with response to Verastem's lead focal adhesion kinase inhibitor, VS-6063, and to develop a companion test for the drug.

Verastem plans to use certain biomarkers to stratify ovarian cancer and meshothelioma patients receiving VS-6063 in a clinical trial slated to begin later this year. By using the biomarkers to identify a best-responder population, Verastem is hoping to accelerate development and regulatory approval of VS-6063.

According to Verastem, research led by company cofounder Robert Weinberg has shown that FAK signaling is linked to the process by which cancer stem cells drive tumor growth. VS-6063 blocks FAK signaling which in turn kills cancer stem cells.

Additionally, early proof-of-concept trials suggest that mesothelioma patients lacking the tumor suppressor Merlin may be particularly responsive to FAK inhibition. Approximately 50 percent of mesothelioma patients lack Merlin, Verastem estimates.

According to Verastem, the company is planning to initiate multiple clinical trials in 2013 invovling VS-6063, including possibly a pivotal study in mesothelioma.

LabCorp will be responsible for developing a companion test to pick out which mesothelioma patients lack the tumor suppressor.


Foundation Medicine Raises $13.5M in Expanded Series B Funding Round

Having netted $13.5 million in additional Series B funds from investors this week, Foundation Medicine said it plans to use the cash to expand commercial and clinical trial efforts, grow laboratory capabilities, and develop genomic profiling and information services.

Last year, Foundation launched its first targeted cancer sequencing test, FoundationOne. According to the company, 700 oncologists from 21 countries have ordered FoundationOne.

The Series B founding round brought in new investors, including Bill Gates, Evan Jones, and Yuri Milner. Existing investors included Deerfield Management Company, Casdin Capital, Redmile Group, Roche Venture Fund, WuXi Corporate Venture Fund, and Laboratory Corporation of America Holdings. Other investors in the company include Third Rock Ventures, Google Ventures, and Kleiner Perkins Caufield & Byers.

In September, Foundation Medicine raised $42.5 million in the Series B round. The new financing brings the total raised in the round to $56 million.


Qiagen to Develop Tests to Personalize Treatment for Rheumatoid Arthritis, Colorectal, Lung Cancers

Qiagen this week made several deals to expand its portfolio of molecular diagnostics for rheumatoid arthritis, colorectal cancer, and lung cancer.

First, the firm made an equity investment in Drug Response Dx, giving it the option to obtain worldwide rights to biomarkers associated with rheumatoid arthritis patients' response to TNF-alpha inhibitors. Between 60 percent and 70 percent of rheumatoid arthritis patients are likely to benefit from TNF-alpha inhibitors, but doctors often can't discern which patients are responders until after six months on treatment.

"A companion diagnostic to predict which rheumatoid arthritis patients are likely to respond to TNF-alpha inhibitors would improve quality of life for patients through tailored and earlier use of the most effective drugs, while also decreasing costs due to failed treatments," Qiagen said in a statement. Qiagen and German investor High-Tech Grunderfonds are together funding Drug Response Dx.

Second, Qiagen licensed exclusive global rights from Insight Genetics for the RET, ROS1, and DEPDC1 biomarkers associated with non-small cell lung cancer. Although the prevalence of the individual markers is small in NSCLC patients, when considered together, these markers show up in one out of ten cases, the company said.

Patients with ROS1 mutations have shown in early studies to respond well to ALK inhibitors, such as Pfizer's Xalkori (PGx Reporter 6/6/2012). However, "there are no regulatory-approved commercial tests to reliably and efficiently identify these biomarkers," Qiagen said in a statement.

Qiagen and Insight are already working together to develop companion tests that gauge rearrangements in ALK.

Third, Qiagen Marseille has gained exclusive worldwide rights from the French National Institutes of Health and Medical Research technology transfer office for mutations in the HSP110 gene. These markers can be used to identify colorectal cancer patients with microsatellite instability, which occurs in 15 percent of patients with the disease. Also, one-third of colorectal cancer patients with MSI have Lynch syndrome, which places them at heightened risk for developing a second cancer.

"Qiagen intends to develop the biomarkers into a diagnostic test for routine use in the diagnostic work-up of colorectal cancer patients," the firm said.

The Scan

UK Team Presents Genetic, Epigenetic Sequencing Method

Using enzymatic DNA preparation steps, researchers in Nature Biotechnology develop a strategy for sequencing DNA, along with 5-methylcytosine and 5-hydroxymethylcytosine, on existing sequencers.

DNA Biobank Developed for French Kidney Donors, Recipients

The KiT-GENIE biobank described in the European Journal of Human Genetics contains DNA samples, genotyping profiles, immune patterns, and clinical features for thousands of kidney donors or transplant recipients in Nantes, France.

Cardiometabolic Disease May Have Distinct Associations With Microbial Metabolites in Blood, Gut

By analyzing gut microbes in combination with related metabolites in feces and blood, researchers in Nature Communications found distinct cardiometabolic disease relationships at each site.

Study Reveals New Details About Genetics of Major Cause of Female Infertility

Researchers in Nature Medicine conducted a whole-exome sequencing study of mote than a thousand patients with premature ovarian insufficiency.