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With 9K Tests Ordered, Foundation Medicine Highlights Utility in Patient Care and Drug Trials

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Foundation Medicine said this week at the JP Morgan Healthcare Conference in San Francisco that it received orders for 9,000 of its FoundationOne next-generation sequencing cancer tests in 2013.

The company targets its test to both oncologists to help guide treatment of patients and also to pharmaceutical companies. During a presentation at the conference, CEO Michael Pellini highlighted the test's benefits to both groups and gave an overview of how the company plans to move forward in 2014 and the years ahead.

In December, the company launched its second product, FoundationOne Heme, which analyzes the 236 genes in the original FoundationOne test and an additional 169 genes specific to hematological malignancies, and applies RNA sequencing to 265 genes.

This week, Pellini highlighted two examples of how the FoundationOne test could be used by oncologists in clinical care and by pharmaceutical companies to guide clinical trial decisions.

For example, he said, in 2012 a 58-year old female was diagnosed with non-small cell lung cancer with brain metastases after going to the hospital because of new onset seizures. The brain mass was removed and a PET/CT scan showed a metabolically active abdominal mass. The oncologist started her on four cycles of chemotherapy. A follow-up in September 2012 showed that there was no change to the abdominal mass but found additional nodules. Initial molecular testing showed that the patient was negative for EGFR mutations and negative for ALK rearrangements, but had a KRAS mutation.

The findings did not point to any targeted therapy. The oncologist decided to order Foundation's test, which identified a MET amplification and also confirmed that the patient had a KRAS mutation. The MET amplification led the oncologist to prescribe crizotinib, an ALK and MET inhibitor marketed by Pfizer as Xalkori.

After three months, the PET/CT scan showed a 40 percent reduction in the size of the abdominal mass and minimal metabolic activity. By November 2013, the patient showed complete response, Pellini said. Typically, "median progression-free survival for a patient with this diagnosis is on average three months," he said.

Aside from patient care, Pellini said Foundation's tests can be used by pharmaceutical companies and even have the potential to save clinical trials or make them more effective.

For instance, he said, AstraZeneca announced in December 2011 that a PARP inhibitor it was developing had failed in a phase II trial and that the firm would not progress to phase III trials.

The pharmaceutical company partnered with Foundation Medicine and the companies did a retrospective analysis using the FoundationOne test to molecularly profile patient samples. The analysis "identified a subgroup of patients with somatic BRCA alterations" who had a different response to the drug, Pellini said.

Just three months following that analysis, in September 2013, AstraZeneca announced that it would conduct two phase III trials in ovarian cancer patients with those BRCA mutations.

Market Opportunity

In terms of patient care, Pellini said that the initial market for FoundationOne will be a subset of the 13 million patients in the US with cancer. The company will primarily focus on the unmet need population, estimated at around 1 million patients annually. These include patients with uncommon cancers, like salivary or gall bladder cancers "where there is no standard molecular testing performed," Pellini said. It also includes patients with aggressive forms of cancer like pancreatic cancer and glioblastoma, patients with common cancers that have advanced after an initial line of therapy, and lung cancer patients whose initial molecular workup is negative.

The market for FoundationOne Heme is currently around 100,000 patients annually, as the test will initially target refractory cases, except for myelodysplastic syndromes and some leukemias like acute myeloid leukemia, acute lymphocytic leukemia, and chronic lymphocytic leukemia.

Over the next couple of years, Pellini said the total market for both tests would grow to around 2 million patients annually as the tests expand to greater numbers of advanced cancer patients and as the number of targeted therapies increase.

While Pellini did not break out the market opportunity for clinical trials and pharmaceutical partnerships, he highlighted several planned and ongoing studies and clinical trials that make use of the FoundationOne test, including a study with US Oncology to evaluate the test's impact on treatment decisions for cancer patients. Initial data from that study is expected this year.

The company is also planning a study to incorporate its test into a randomized trial of matched versus unmatched therapy as well as a study looking at the use of its test in earlier stage disease.

Earlier this week, Foundation Medicine pre-reported some of its 2013 fourth quarter results, saying that orders for FoundationOne have increased each quarter since its launch. In the fourth quarter of 2013, it received orders for 3,750 tests, up from 2,577 in the third quarter 2013 and from 878 tests in the fourth quarter of 2012.

It received orders for 9,000 tests for the entire year. Revenue from tests as well as from its partnerships with pharmaceutical companies translated into around $29 million for the entire year, up from less than $11 million for 2012.

Looking ahead to 2014, Pellini said this week that the company expects to deliver between 22,000 and 25,000 clinical reports and to bring in between $52 million and $58 million in total revenue.

Additionally, it plans to expand the FoundationOne test in the first half of the year and add features and outcomes capabilities to its Interactive Cancer Explorer physician portal.

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