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A Year After Divesting Proteomics Biz, Vermillion Plans to Debut its First Dx

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Almost one year to the day after setting out on its transition from a proteomics outfit to a molecular diagnostic company, Vermillion is ready to launch its first test.
 
This week, the company once called Ciphergen announced it has licensed its assay for thrombotic thrombocytopenic purpura to Ohio State University, which will develop it as a laboratory test and offer it in its reference lab by the end of the month.
 
Financial terms of the agreement were not released.
 
Vermillion also said this week that the US Patent and Trademark Office has issued a reexamination certificate for a patent related to the surface enhanced laser desorption ionization technology, entitling the company to a $2 million payment from Bio-Rad Laboratories, which bought the technology from Vermillion a year ago.
 
A year ago, Vermillion left the proteomics business by selling its SELDI business to Bio-Rad and refocusing its efforts exclusively on its nascent diagnostics business [See PM 08/17/06]. Since then, its revenue stream has evaporated, and in filings with the US Securities and Exchange Commission the company has warned that it faces imminent threat of having to shut down its business if it cannot remedy the situation.
 
Its fortunes have hinged on commercializing tests for three diseases: ovarian cancer, peripheral arterial disease, and TTP, which is a clotting disorder. At an analyst conference this week, CEO Gail Page reiterated expectations that Vermillion plans to submit data for its ovarian cancer triage test to the US Food and Drug Administration by the end of the year.
 
In the meantime, the TTP test would represent the first diagnostic commercialized by Vermillion. OSU was a co-developer of the test, which measures the levels of the enzyme ADAMTS13. Loss of the enzyme causes platelet clumping and red blood cell destruction, leading to neurological abnormalities and abnormalities in kidney function, Vermillion said in a statement.
 
Vermillion and OSU entered into the two-year collaboration to develop the test in October 2006. The agreement has automatic renewals for two additional one-year terms. During the first 15 months of the agreement, Vermillion would pay the university $150,000 for costs incurred to develop the test, according to documents filed with the SEC.
 
“Having this test available to patients marks a significant milestone for Vermillion as we continue to build our high-value molecular diagnostics business,” Page said in a statement. “This diagnostic test is a testament to the power of our diagnostic technology and development capabilities.”
 
About its blood-based ovarian cancer triage test, a panel of seven protein biomarkers that has been in development for more than three years, the company recently said it had finished enrolling 550 patients for its clinical trial for the test, which will be performed at 27 sites [See PM 10/25/07].
 

“We hope that it’ll all be finalized by the end of the year, and then we will submit to the FDA rapidly thereafter, and we’re certainly working on preparing our submission as we speak today.”

The sites are currently doing the testing, Page said this week. “We hope that it’ll all be finalized by the end of the year, and then we will submit to the FDA rapidly thereafter, and we’re certainly working on preparing our submission as we speak today,” Page told analysts this week.
 
The test trial was designed with the help of the FDA, she said, to increase its chances of getting market approval. The company is hoping approval will come in early 2008, Page said.
 
The third test in the pipeline, for PAD, is being developed in collaboration with Quest Diagnostics. A four-protein biomarker panel, the blood-based test could be launched in early 2008 as a laboratory-developed test, Page said. The test is targeted at primary-care physicians who will administer the test with regular blood workups.
 
Vermillion will be working on market development for the PAD test while Quest will do the actual marketing. Quest will “drive the ordering at the physician-practice level and we will be targeting advocacy groups and the PAD coalition,” Page said.
 
This week also, Vermillion said the USPTO has issued a reexamination certificate for US Patent No. 6,734,022. As a result, Bio-Rad Laboratories is expected to pay the company $2 million as part of its total $20 million purchase of the SELDI technology from Vermillion last year.
 
The patent relates to a fundamental process of SELDI, involving the “capture of an analyte from a sample on the surface of a mass spectrometry probe derivatized with an affinity reagent, applying matrix, and detecting the capture analyte by laser desorption mass spectrometry,” Vermillion said in an SEC document. If the USPTO did not issue a reexamination certificate, Bio-Rad could have withheld the $2 million payment.
 
The payment would represent a crucial capital infusion to cash-strapped Vermillion, which faces delisting from the Nasdaq exchange for being non-compliant with a rule that its bid price be at least $1 per share for at least 30 consecutive days. Vermillion has until March 4, 2008, to regain compliance.
 
In September, the company netted $20.6 million after closing a private placement of common stock [See PM 09/06/07].

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