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NextGen to Offer Mass Spec-based Assays after Transition to Biomarker Business

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By Tony Fong

NextGen Sciences will be making available four multi-protein assays in about a month, the first commercial product launches since it became a biomarker firm a year ago, its CEO told ProteoMonitor this week.

The four mass spectrometry-based assays will consist of one absolutely quantified 21-protein panel from cerebrospinal fluid; a 30-protein panel also from CSF; a 20-protein panel from plasma; and an "a la carte" panel of about 150 proteins derived from plasma, NextGen CEO Mike Pisano said.

The CSF protein panels are for neurodegenerative disease and dementia, while the plasma protein panels are targeted for heart disease. Any company or researcher interested in using the assays would send their samples to NextGen who would run the samples against the assays.

Pricing for the assays has not yet been determined.

For the Ann Arbor, Mich.-based firm, which began its biomarker service business in late 2007, the assays would be the first products to be launched derived from its library of about 1,000 proteins from human plasma, CSF, and urine.

The library is based in part on work the company has done "just taking and mapping plasma, CSF, urine from human samples and them mapping that and then … putting together assays for each of those proteins," Pisano said.

Some of the proteins in the library were also developed from collaborations NextGen has struck with its pharmaceutical, biotech and in vitro diagnostic customers. While the "a la carte" assay will initially have 150 proteins, the number will grow in step with the number of proteins for which NextGen develops assays, Pisano said.

During the next year, the company will develop an "a la carte" assay with CSF proteins, he added. Customers would pick the proteins they want to be investigated.

Other assays being developed for NextGen's clients may also be commercialized.

Eventually, Pisano said, the "off-the-shelf" assay business could become at least as big as NextGen's biomarker services.

"We're still in that phase of biomarker work where people are trying to figure out which biomarkers work," he said. "There are lots of putative markers out there, but there aren't a lot of validated markers, especially in areas such as patient stratification [and] drug development."

NextGen's assays would allow researchers to have a clearer idea about the quality of their candidate markers, he said.

"They don't know where to start," Pisano said. "I can have a list of proteins, but that's meaningless. Now I need to figure out which ones are meaningful in the context of what [I'm] studying. … The lack of assays is the big problem."

Biomarkers Onward

The planned launch of the assays also would represent the continued evolution of NextGen from a technology development company to one focused on biomarker discovery and validation and assay development.

Before Pisano joined the company in 2006 after NextGen acquired Proteomic Research Services, NextGen didn't even have a biomarker service business. Pisano had been CEO and co-founder of PRS. One year later, NextGen added biomarkers to its offerings.

The company started its shift to a full-time biomarker services company in late 2008 when it divested its automation and software business to a company formed by former NextGen employees [See PM 12/11/08]. The transformation was completed when it sold its electrophoresis operations to Sigma-Aldrich a few months later [See PM 03/05/09].

This week, Pisano said that the business, called biomarkerexpress, was "working quite well," though he declined to provide any revenue figures because the company is about to do its audit for full-year 2009.

According to its interim report for the first six months of 2009, NextGen, whose stock is traded on the Alternative Investment Market of the London Stock Exchange, said it posted receipts of $807,769 and a loss of $1.1 million.

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The uptick in the business has come primarily from small to mid-sized pharmaceutical and biotechnology firms. Furthermore, large pharma is again showing a willingness to spend and a renewed interest in protein biomarkers, as evidenced by partnerships and deals NextGen has been able to forge with Japanese pharma during the past year, Pisano said.

Earlier this month, NextGen announced a deal with Takeda Pharmaceutical to develop protein biomarker assays [See PM 02/05/10]. It also has forged deals with other Japanese companies though Pisano declined to identify them, citing confidentiality agreements.

Several years ago, the Japanese pharma sector went through a sharp downturn before US and European pharma saw a similar softness. The Japanese market, however, is emerging from its slumber, and Pisano said that could foreshadow a similar openness to spending by US and European pharma.

"Now we're starting to see interest from large pharma, but really it's a sales cycle thing," he said. "The sales cycle for large pharma is just longer than it is for the smaller companies."

NextGen is not the only one sensing the change. After the dearth of clinical breakthroughs blunted the initial enthusiasm for proteomics about a decade ago, pharmas and biotechs shut down their in-house proteomics operations and many standalone biomarker firms went under.

Recently, there are some preliminary signs that pharma and biotech may be revisiting the biomarker space. Last year, contract research organization Covance established a Biomarker Center of Excellence and entered into a biomarker deal with Rules Based Medicine in response to an increase in demand for the company's biomarker services, Tom Turi, vice president of the BCOE, told ProteoMonitor [See PM 12/11/09].

During the most recent quarterly earnings releases, some mass spec vendors reported better, but still-soft, pharma/biotech business, as those customers started to once again buy capital instruments such as mass specs.

Whether this means pharma/biotech will bring back their protein biomarker work in house is unclear, but Pisano said that drug companies and biotechs no longer have an appetite to do biomarker work and assay development themselves.

"If they can get someone [who] can help them from discovery through clinical trials, that's one vendor versus multiple vendors doing multiple things along the way," he said. "They're moving toward single source, if you will, for everything. Evidence of that is all of these pharma companies are putting together outsourcing groups. That's their sole job — to manage the outsourcing that goes on in the company."

For the future, NextGen is eyeing areas such as biologics that have yet to impact the biomarker space.

"If you look at cancer drugs, the majority of the new cancer drugs are antibodies … and those will have to be monitored and the regulatory agencies will put more and more stringent requirements on them," he said.

Indeed, during the summer, trying to capitalize on biopharma's outsourcing business, Sigma-Aldrich launched a new protein service business. The services offered include protein identification from gel bands, sequence analysis, and glycan analysis. Classic biomarker services, such as discovery, verification, and validation, are not on the menu, however [See PM 06/11/09].

In traditional small-molecule work, increased biomarker research is being directed at predicting and monitoring drug efficacy and patient-drug reactions, which may eventually become another revenue source for NextGen, Pisano said.

For the immediate future, though, the company has its attention on traditional CRO work.

"We've got the discovery side going, we've got the assay-development side going. Now it's time to get the testing side going," Pisano said. "That's what we're really focused on for this year, to get that part up and running."

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