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Ciphergen Gets Ready to Bring Its Ovarian Cancer IVD to US, Europe

Ciphergen Biosystems continued forging ahead as a specialty diagnostic firm with a series of announcements during the past week. Earlier this week, it announced it had hired the Emergo Group to help its ovarian cancer test win regulatory approval in Europe as an in vitro diagnostic.
The company said it hopes to begin selling the test in at least one European country in 2007.
Ciphergen also said it tapped contract research organization PrecisionMed to support clinical trials in the US for the test, which the company hopes to file for US Food and Drug Administration clearance during the second half of 2007.
And finally, it said it will be working with Mosaic Health Care Consultants to develop reimbursement strategies for the test.
For a company recently transformed from a proteomics tool outfit into a diagnostics firm, the agreements are Ciphergen’s latest efforts in its ongoing push toward financial viability.
Under the terms of the Emergo deal, Emergo will act as Ciphergen’s representative in Europe. In addition to registering Ciphergen’s test with the different health ministries in Europe and acting as a liaison between the company and the ministries, Emergo will assist the company should any issues arise during the approval process or after approval, such as during any recalls of products, said Chris Schorre, director of marketing for Emergo.
Based in Austin, Texas, Emergo does similar work for about 300 companies worldwide, Schorre said. Emergo is an ISO-registered medical device-consulting company with offices also in the Netherlands, Canada, Australia, and China.
Both Emergo and Ciphergen declined to disclose the financial terms of their agreement.
Ciphergen’s ovarian cancer test, based on a panel of biomarkers and the Surface Enhanced Laser Desorption/Ionization technology, is aimed at differentiating ovarian cancer from benign pelvic masses. According to Ciphergen, ovarian cancer kills 14,000 women in the US annually while 23,000 new cases are diagnosed each year.
Ciphergen’s international ambitions for its ovarian cancer test were made public in November when President and CEO Gail Page told analysts that “we expect to be able to offer this test in at least one [other] country next year.”
This week, Ciphergen spokeswoman Daryl Messinger told ProteoMonitor that the company has done some preclinical trials in Europe and, “based on that data, they’ll be filing for a CE mark in Europe this year and hoping to get clearance in at least one European country next year. The US clinical trials will help that submission as well.”
Schorre said because the regulatory process is less cumbersome and less time-consuming in Europe, it makes sense that Ciphergen would seek entry into that market first. In the US, a novel diagnostic product that has no competitors already on the marketplace may have to go through clinical trials to show efficacy and safety. In Europe, however, if such a product meets certain classification guidelines, it can get approval relatively quickly and at a lower cost to the company, he said.
“As long as it meets the classification guidelines, [even] if it’s completely new and novel, it doesn’t matter,” Schorre said. “These guidelines are spelled out ... [and say] ‘OK, if your medical device is this, it falls into this classification.’ And if you, for instance, had a device that didn’t fall into those guidelines, then you, indeed, might have to do clinicals.
“It’s not like you don’t have to do clinicals in Europe in order to get your product approved. But a lot of clients have said that it is easier, and we advise some clients to go the European route first,” Schorre said.
Neither Messinger nor Schorre could say when Ciphergen would be filing for European approval.
Meanwhile, Ciphergen’s deal with PrecisionMed calls for the San Diego-based CRO to “perform the study setup, protocol review, site recruitment, site monitoring, and project management for Ciphergen’s clinical trials,” according to a Ciphergen press release.
John Flax, president of PrecisionMed, said the company will be responsible for sample collection and processing but declined to provide additional details, citing a confidentiality agreement.
Messinger also declined to provide details of the agreement or comment further about the upcoming clinical trials. She said that the trials will be initiated “shortly” and Ciphergen will seek FDA approval during the second half of 2007.
In the company’s release announcing the deal, Page said, “The selection of a CRO to support our ovarian tumor triage test clinical trial program is an important milestone in our product development efforts.”
Founded in 1994, PrecisionMed is a biobanking company. It handles mostly serum and cerebral spinal fluid, but also has DNA material, PAXgene RNA, and urine, among other types of biological samples, Flax said. Its customers include nine of the top-10 drug companies in the world, Flax said.
Meanwhile, Ciphergen said that its partnership with Mosaic would help develop a reimbursement structure, crucial to achieving rapid adoption of the ovarian cancer test by the medical community.
Together Ciphergen and Mosaic will establish strategies to ensure reimbursements from public and private payers.

The company has done some preclinical trials in Europe and “based on that data, they’ll be filing for a CE mark in Europe this year and hoping to get clearance in at least one European country this year. The US clinical trials will help that submission as well.”

Cash Crunch

For Ciphergen, which recently sold its SELDI product line to Bio-Rad [See PM 11/09/06  and 11/16/06] marking its exit fromthe proteomics tools space, the announcements of the past week come as Ciphergen fights to stay afloat.
In November, Ciphergen said that it “does not anticipate having significant revenue until its diagnostic tests are commercialized,” though it has enough cash to maintain operations for at least the next year. Ciphergen said it had around $15 million in cash and cash equivalents as of Sept. 30.
At the time, Ciphergen reported that third-quarter revenues decreased 34 percent to $4.7 million, with most of that revenue coming from sales of its ProteinChip arrays, SELDI instruments, and its biomarker development services, which are now part of Bio-Rad.
That period also saw the company’s net losses decline to $7 million from $7.5 million in the year-ago period. Since the start of the year, Ciphergen’s stock price has fallen by more than a quarter of its value.
In addition to the ovarian cancer test, Ciphergen is working with Stanford University to develop a diagnostic for peripheral arterial disease, and with Ohio State University on a test to detect thrombotic thrombocytopenic purpura.
The company also has a deal with Quest Diagnostics to develop tests based on the SELDI protein array technology. As part of the deal, announced last year [See PM 07/28/05], Quest is developing a diagnostic for ovarian cancer to market as an analyte-specific reagent test.
The deal calls for Quest to pay Ciphergen royalties on fees earned by Quest for applicable diagnostic services. Ciphergen would have to pay royalties to Quest on Ciphergen’s revenues from applicable diagnostic products.

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