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Cepheid Pipeline Update Focuses on Tests for CT/NG, Cancer, TB

NEW YORK (GenomeWeb News) – Cepheid this week updated its test pipeline with a focus on gonorrhea and chlamydia, cancer, and tuberculosis over the next few years.

Speaking at two investor conferences, Cepheid CEO John Bishop outlined his company's plans to expand its testing menu through 2017, when if all goes according to plans, the company would have a total of 42 tests available globally.

While the expansion of its testing menu ranges widely and includes tests for HIV, hepatitis C and B, norovirus and others, Bishop directed most of his comments at three disease areas. For CT/NG, especially, he said that the firm's tests, Xpert CT/NG and Xpert CT, will be game changers. The tests received CE-IVD marking in Europe a few weeks ago and Cepheid expects to file its 510(k) submission with the US Food and Drug Administration this week, Bishop said.

In Europe CT/NG testing represents a $120 million market opportunity, with Roche capturing about a 47 percent share. Cepheid's go-to-market strategy there will vary country by country due to "big differences in symptomatic versus asymptomatic testing," Bishop told investors at the Jefferies 2012 Global Healthcare Conference, which was webcast.

Already, he noted, interest is high in the scalability of Cepheid's product in both the high-throughput GeneXpert Infinity system as well as the lower scale systems "as this product is immediately applicable to STD clinics in that marketplace."

In surveying physicians in Europe, he said, Cepheid found that half expressed the need for a 90-minute test and 70 percent wanted on-site testing capabilities. "So we feel that we're very well positioned at this point in time to penetrate the European market," he said.

In the US, where Cepheid hopes to receive FDA clearance by the end of this year, Gen-Probe is the market leader. The focus of sales efforts will then be on the approximately 2,000 laboratories that already perform molecular testing.

About one-third of these labs send out their CT/NG tests. Cepheid has about 1,100 system placements in the US, and the immediate strategy is to target those labs that have a Cepheid system and are sending out their CT/NG tests, followed with efforts at labs with a Cepheid system but are using a competitor's CT/NG test in house. Lastly, the company will target labs without a Cepheid system and are sending out their CT/NG tests.

Bishop also highlighted the fact that Cepheid's tests are moderately complex, compared to the high complexity of competing products, which will allow them to go immediately into group practice laboratories that can conduct moderately complex tests.

"That has been an aspect of the market [that] has been overlooked with our whole go-to-market strategy … and I think that that's going to add substantively, relative to where we will be going and market penetration for the future," Bishop said.

At the Goldman Sachs 33rd Annual Global Healthcare Conference, he also identified tuberculosis testing as a key initiative for Cepheid in the US in 2013. The US has a low rate of TB incidence, but still represents an opportunity of between 400,000 and 500,000 tests annually, he said, and added that interest and demand for Cepheid's test runs high, resulting in the downgrade of the classification of its test from a premarket approval device to a 510(k) de novo device.

Cepheid plans to file its TB test with FDA by the end of the year with a targeted launch during the first half of next year.

Additionally, the company is working through the regulatory process for the test in China where Cepheid anticipates it becoming available by the end of the year.

Longer term, the firm will take a "big step up" in tests targeting oncology, specifically bladder, breast, and colon cancers, Bishop said. The bladder cancer products will be for diagnosing and monitoring the recurrence of the disease and are expected to launch in the 2014-2015 timeframe.

In 2016-2017, Cepheid plans to expand its test menu to include breast cancer and colon cancer. In breast cancer, Cepheid intends to offer products for stratifying patients for treatments, while for colon cancer its products would be for monitoring the test, including the monitoring of polyps that develop into cancer.

While Cepheid's deployment of capital will go mainly to the build-out of its product pipeline, in the area of cancer, the company plans to shop for M&A opportunities that will increase the value of its oncology franchise, Bishop said.

"Our knowledge today of markers that really are making a difference in oncology, we're at the very, very beginning, so we, like everybody else, are going to be opportunistic as discoveries are made relative to content with regard to those markers," he said at the Goldman Sachs conference, which also was webcast. "And we are very much going to plan to be attuned to the market, integrative in that area, and then where we need to deploy capital to pick up access to targets, we'll definitely do that," he said.

During 2013, the company plans to launch five new tests in the US, bringing the total of tests available to 22: Mycobacterium tuberculosis; a CLIA-waived test for the flu; Group B Streptococcus type lb; and vaginitis.

Next year, Cepheid also plans to bring to market four new tests outside of the US, bringing the total to 16. The roster includes tests for multi-drug resistant organisms; norovirus; human papillomavirus; vaginitis; and a new version of a test for monitoring the BCR-ABL oncogene.

Moving into 2014-2015, nine test launches are targeted for the US and seven are planned for outside the US. By the end of 2017, Cepheid plans to have 37 tests available in the US and 36 tests elsewhere.