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Biotech / Medical : Ciphergen Biosystems(CIPH): -- Ignore unavailable to you. Want to Upgrade?

To: bunn who wrote (455)	10/15/2006 1:57:56 PM
From: tuck	Read Replies (1) \| Respond to of 510

[Preanalytical and analytical variation of surface-enhanced laser desorption-ionization time-of-flight mass spectrometry of human serum] I don't know exactly what step to take, but it has to be something. The company has said snap-freezing, which most clinical diagnostic labs are not rigged for, was not required. But it's clear that deterioration of the serum sample through clotting or whatever must be stopped if they expect to get consistent, clinically relevant results. I think it's been shown that snap-freezing would do the trick, but it apparently isn't commercially practical. What, then, Ciphergen? The one bit of good news here is the senstence "The protein peaks in serum in healthy individuals showed no variation with gender, age, fasting, or diurnal rhythm." >>Clin Chem Lab Med. 2006;44(10):1243-52. Preanalytical and analytical variation of surface-enhanced laser desorption-ionization time-of-flight mass spectrometry of human serum. Albrethsen J, Bogebo R, Olsen J, Raskov H, Gammeltoft S. 1. Department of Clinical Biochemistry, Glostrup Hospital, Glostrup, Denmark. Background: Surface-enhanced laser desorption-ionization time-of-flight (SELDI-TOF) mass spectrometry of human serum is a potential diagnostic tool in human diseases. In the present study, the preanalytical and analytical variation of SELDI-TOF mass spectrometry of serum was assessed in healthy individuals. Methods: Serum and plasma were obtained from healthy human individuals. Protein peaks in human serum and plasma were determined by SELDI-TOF mass spectrometry. Results: The protein peaks in serum in healthy individuals showed no variation with gender, age, fasting, or diurnal rhythm. The intensity of protein peaks changed significantly during clotting of serum from 30 to 60 min, followed by smaller changes from 60 to 120 min. The intensity of protein peaks changed after 60-min storage of serum at room temperature, whereas no changes were observed for storage on ice. The number of reproducible protein peaks in serum was determined on WCX2, SAX2, and IMAC30 arrays as 29, 34, and 36, respectively. The average coefficient of variation (CV) of the mass value of protein peaks was 0.03%. The intra-assay CV of peak intensity on IMAC30 arrays was 16% (10%-36%, n=8) for 36 peaks, inter-assay CV was 18% (6%-34%, n=4) for 16 peaks, and inter-individual CV was 38% (16%-56%, n=16) for 20 peaks. Conclusions: The pre-analytical and analytical conditions of SELDI-TOF mass spectrometry of serum have a significant impact on the protein peaks, with the number of peaks low and the assay variation high. Consequently, SELDI-TOF mass spectrometry of serum needs further evaluation before application in clinical diagnostics. << Maybe this is the hold up at Quest. Maybe they can't figure out how to practically stop deterioration of the samples. Until Ciphergen publicly and squarely addresses this, I'll be looking for the exit. Go ahead an submit the relevant patent app, but then tell us about it, please. Cheers, Tuck

To: bunn who wrote (455)	9/7/2007 5:09:50 PM
From: tuck	Respond to of 510

>>Vermillion, Inc. Announces Receipt of Notice of Noncompliance From Nasdaq Friday September 7, 5:00 pm ET FREMONT, Calif., Sept. 7 /PRNewswire-FirstCall/ -- Vermillion, Inc. (the "Company") (Nasdaq: VRML - News) today announced that on September 6, 2007 it received a notice of noncompliance from The Nasdaq Stock Market ("Nasdaq") indicating that the Company fails to comply with the minimum bid price requirement for continued listing set forth in Marketplace Rule 4310(c)(4). The letter gives the Company notice that the bid price of its common stock has closed under $1.00 for the last 30 business days. Pursuant to Nasdaq Marketplace Rule 4310(c)(8)(D), the Company has been provided an initial period of 180 calendar days, or until March 4, 2008, to regain compliance. The letter states the Nasdaq staff will provide written notification that the Company has achieved compliance with Rule 4310(c)(4) if at any time before March 4, 2008, the bid price of the Company's common stock closes at $1.00 per share or more for a minimum of 10 consecutive business days. If the Company cannot demonstrate compliance with Rule 4310(c)(4) by March 4, 2008, the Nasdaq staff will determine whether the Company meets The Nasdaq Capital Market initial listing criteria set forth in Nasdaq Marketplace Rule 4310(c), except for the bid price requirement. If the Company meets the initial listing criteria, the Nasdaq staff will notify the Company that it has been granted an additional 180 calendar day compliance period. If the Company is not eligible for an additional compliance period, the Nasdaq staff will provide written notice that the Company's securities will be delisted. At that time, the Company may appeal the Nasdaq staff's determination to delist its securities to a Listing Qualifications Panel.<< snip Note that they got this letter yesterday, but chose not disclose it until after the market closed today. Trustworthy management team, huh? Not. Cheers, Tuck