Quest Diagnostics has made a $15 million equity investment in Ciphergen Biosystems, giving Ciphergen's diagnostic platform a huge endorsement, and perhaps putting a dent in lingering doubts about the potential for proteomic biomarkers in molecular diagnostics.
As part of the deal, which gives Quest a 17-percent stake in Ciphergen and operating control of the company, the diagnostics behemoth will develop three diagnostic assays selected from Ciphergen's pipeline, but neither company would name the three assays to be carried on to further development and commercialization.
However, if Ciphergen's preference can be used as a gauge, the firm's ovarian cancer diagnostic is in the running. During a conference call with investors, Gail Page, president of the firm's diagnostic division, described that program as Ciphergen's most advanced. If that's the case, Ciphergen seems to have its work cut out for it; researchers in the field have described it as less than perfect.
"It's simply premature [to say which three diagnostics interest Quest], and all it does is set unrealistic expectations for people," said Gary Samuels, a spokesperson for Quest. "It is fair to say that both companies will play a role in clinical validation, but as far as what the outcomes will be in terms of a product, it just doesn't make sense for us to start speculating."
"There are significant resources in Quest, and [Quest] doesn't seem to get involved in things that aren't going to be worthwhile."
But its large investment in Ciphergen suggests that Quest certainly sees future value. "We think that proteomics technology will be very important in patient care in the long term," Samuels said. "We feel strongly enough that we put our money where our mouth is." Quest was not ready to reveal further details beyond the alliance, but "what we want to tell people is that there's more to come," he said.
"There are significant resources in Quest, and [the company] doesn't seem to get involved in things that aren't going to be worthwhile," said Oliver John Semmes, an associate professor of molecular biology at the Eastern Virginia Medical School, in an interview with ProteoMonitor.
In the past, Ciphergen has emphasized its work in proteomics biomarker discovery and validation for Alzheimer's disease, prostate cancer, and breast cancer, in addition to its flagship ovarian cancer test. According to company officials, Ciphergen has identified a panel of protein biomarkers that can predict Alzheimer's with 86 percent accuracy. As recently as last fall, Ciphergen researchers were completing an 1,100-sample validation study for prostate-cancer biomarkers, and a 176-patient validation study for breast-cancer biomarkers.
Quest spokesperson Samuels also declined to say whether a potential diagnostic coming out of the agreement would even use Ciphergen's SELDI technology. Other options include immunohistochemical testing and mass-spectrometry pattern analysis without SELDI.
But judging from what Ciphergen has to say, SELDI seems a likely option. "What I can say is that the [tests'] performance is best achieved with the SELDI ProteinChip platform," said Page during the conference call.
In addition to buying 17 percent of Ciphergen's stock, which gives Quest controlling interest in the company, the lab giant also agreed to loan Ciphergen up to $10 million to fund certain development activities. The loan would be forgiven based upon achieving certain milestones, the companies said. According to Page, Quest will have an exclusive license to the companies' co-developed diagnostic tests for three years following FDA approval.
Asked if Ciphergen's ovarian cancer test is currently good enough to be commercialized, Andrew Berchuck, a professor of gynecological oncology at Duke University, told ProteoMonitor in May [see PM 5/13/2005] that all of the ovarian cancer tests being developed, including Ciphergen's test, have a long way to go before they can be used to screen for early-stage ovarian cancer. A suitable test should have a specificity of at least 99.5 percent, Berchuck said.
According to Rebecca Caffrey, a former business development manager in the infectious disease department at Ciphergen who spoke to ProteoMonitor last November [see PM 11/5/2004], preliminary analysis of results from a 436-sample validation study showed that the ovarian-cancer test scored between .88 and .91 in specificity and sensitivity, respectively.
Access to Quest's resources and experience, as well as its breadth of clinical samples, should "clearly quicken the process of optimization and validation" for Ciphergen's diagnostic tests, said Semmes, the Eastern Virginia Medical School associate professor. Semmes is also a member of the National Cancer Institute's Early Detection Research Network.
However, Semmes added, the test is "still only as good as the discovery."
"You go through the process of validation and [the results] don't get any better; they often get worse," said Semmes. "If you are a pessimist, you might say that [validation] resources are the resources that help you fail quicker."
On the other hand, a diagnostic can be improved by adding secondary biomarkers, Semmes noted. For example, biomarkers that can be used in conjunction with the standard PSA test for prostate cancer to distinguish false positives from true positives could be of great benefit to health care.
In addition, using a combination of different diagnostic tests for the same disease might improve overall test results as well, Semmes said. If this is the case, the OvaCheck test developed by Correlogic another company in which Quest has an equity investment might play a complementary role to Ciphergen's ovarian cancer test.
Samuels said that Quest is not ready to talk about when it expects a diagnostic test from Ciphergen to reach the clinic, or whether Ciphergen's current diagnostic tests can be improved.