NEW YORK (GenomeWeb) – Diagnostics firm Applied Proteomics is shifting is business strategy to rely more heavily on deals with outside partners to commercialize its protein-based tests.
The company has determined that "it may not be in our best interest to stand up our own sales force," said CEO Premal Shah, noting that API plans moving forward to focus its resources on test and assay development as opposed to test commercialization.
This shift begins with commercialization of its second-generation SimpliPro Colon test, a proteomic colon cancer test aimed at increasing colonoscopy compliance in symptomatic patients. The company published a validation study of this test last month in Clinical Proteomics and is now exploring potential commercialization partners.
Shah declined to name any specific companies API was in talks with, but said it is "interested in working with people who have a commercial infrastructure already in place who are able to take this test to the customers, the primary care physicians."
API launched the original SimpliPro Colon at the end of 2015. Shah said that the shift to increased reliance on outside commercialization partners was not due to the company's experience selling the first-generation SimpliPro Colon. He declined to give sales figures for the test since its launch, but he said that on a per-sales-representative basis, sales volume was on par with "other leading companies" in the space in their first three to four quarters after launch.
Deciding between handling commercialization in house and partnering with an outside firm has proved challenging for proteomics companies in the past. Most prominently, Vermillion several years ago ended its licensing agreement with Quest Diagnostics for its OVA1 ovarian cancer test after determining that the company was not well suited to selling that product. At the time, Vermillion's then-CEO Thomas McLain suggested that the sales support needed to drive adoption of the test "is not typical of a reference lab sales force, which generally is advancing a menu of tests and trying to get people to purchase tests on volume."
Since bringing OVA1 sales in house, Vermillion has achieved significant increases in revenue per test, but volumes have remained largely flat, and the company is currently exploring agreements with outside labs to offer the test.
API had previously targeted a launch of the second-generation SimpliPro for this summer, but the timing of its launch will now depend on the how the company's search for a commercialization partner progresses, Shah said.
The new test improves upon the first version primarily in terms of specificity. In the Clinical Proteomics study, the company and its collaborators looked at blood samples from 4,435 patients from seven Danish hospitals with symptoms of colorectal neoplasia who had been scheduled for first-time colonoscopies. Using Meso Scale Discovery's electrochemiluminescence immunoassay platform, they measured the levels of 27 proteins in these patients, using 3,099 to build the new test panel and 1,336 for validation.
Based on the Clinical Proteomics work, the new test is able to distinguish between patients with and without colorectal cancer with sensitivity of 80 percent, specificity of 83 percent, positive predictive value of 36.5 percent, and negative predictive value of 97.1 percent. This performance was consistent across all stages of disease, the authors noted. The original test detected stage I and II CRC with 75 percent sensitivity and 78 percent specificity, and stage III and IV CRC with 88 percent sensitivity and 78 percent specificity.
While colorectal cancer has been API's focus since its launch in 2007, the company is now considering other uses for its mass spec platform, Shah said. He cited areas like cardiology and Alzheimer's saying that the company had done feasibility studies looking into these spaces.
One route a number of proteomics firms have taken is offering their platforms to pharma for fee-for-service or other work to generate revenue while they continue to pursue internal diagnostic development programs. Shah said "that is obviously a potential application" for API, but he added that the company has "not to date engaged in those conversations with pharma companies."
Shah said the company is also exploring building dried blood spot-based mass spec panels of proteins already in common clinical use, with the aim being to compete with existing immunoassays to these proteins.
API has recently presented several posters covering its work using mass spec to measure proteins in dried blood spot samples. Dried blood spots have in recent years emerged as a notable area of interest among proteomics researchers. Typically consisting of microliter volumes of blood spotted and dried on filter paper, dried blood spots can be stored and shipped without refrigeration, meaning they can be sent through standard mail. Conventional blood draws, on the other hand, require rapid, cold shipping via services like FedEx, which are significantly more expensive.
And while dried blood spots' limited sample volume makes them poorly suited to panels of immunoassays, mass spec can measure relatively large multiplexes of proteins in such samples. Proponents of the approach suggest that using mass spec for multiplexed measurement of existing protein markers could significantly reduce assay costs while also allowing for more flexible patient sampling, enabling people to, for instance, prepare a sample in their own home and mail it directly to a lab without having to go to a doctor's office or clinic for a blood draw.
Shah said API has developed more than a dozen mass spec assays for measuring US Food and Drug Administration-cleared protein biomarkers, demonstrating, he said, that it can "develop clinical grade assays off a single dried blood spot that are the equivalent, if not better, than FDA-approved immunoassays."
In this the company is following the lead of researchers like Leigh Anderson, CEO of SISCAPA Assay Technologies, who has been exploring a similar notion for several years. In an interview earlier this year, Anderson, who is not affiliated with API but has collaborated with the company in the past on mass spec workflow development, said he thought API's exploration of dried blood spot samples "makes a lot of sense," and added that he believed the technology is now "clinically workable."
According to Anderson, SISCAPA has built five- to 20-plex dried blood spot protein panels with coefficients of variation in the range of 5 percent or less.