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Sera Planning 2015 Launch of PreTRM Proteomic Test to Assess Preterm Delivery Risk

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NEW YORK (GenomeWeb) – Sera Prognostics plans this year to launch its PreTRM proteomic test for assessing pregnant women's risk of preterm delivery, company Chairman and CEO Gregory Critchfield told GenomeWeb this week.

The firm is currently in the process of validating the test in a 5,500-patient cohort collected through its Proteomic Assessment of Preterm Risk clinical study and expects results of the study to be available in the second quarter of 2015 with commercial launch of the test following around mid-year, Critchfield said.

Sera plans to offer PreTRM through its CLIA lab using multiple-reaction monitoring mass spec on a triple quadrupole instrument. Assuming the test launches on schedule, it will be only the second multiplexed proteomic test to go to market using MRM on a triple quad, following the launch of Integrated Diagnostics' Xpresys Lung cancer test in 2013.

Sera said this week that it closed $20 million in Series B financing that will go towards commercialization efforts. The round followed a $19.3 million Series A round in 2011 and was led by European investment firm Chione, which is a new investor in the firm, and included current Sera investors Domain Associates, InterWest Partners, Catalyst Health Ventures, UpStart Life Sciences Capital, and Osage University Partners.

Based on intellectual property licensed from the University of Utah and Brigham Young University, Sera's preterm birth panel consists of three proprietary peptides plus six additional proteins. The test measures the proteins in pregnant women's blood early in the second trimester to assess their risk of preterm birth.

Critchfield said that final accuracy numbers for the test would not be available until the company had completed validation but that early feasibility studies had put the specificity and sensitivity of the panel in the 80 percent range.

In a study published in the November 2010 issue of the American Journal of Obstetrics and Gynecology, the test demonstrated sensitivity of 86.5 percent and specificity of 80.6 percent for preterm birth at 28 weeks of pregnancy. In February 2011, the company presented data at the Society for Maternal-Fetal Medicine's annual meeting in which the test predicted preterm birth at 24 and 28 weeks gestation with 94 percent sensitivity and 85 percent specificity.

The basic value proposition, Critchfield said, is that by identifying women at risk of preterm delivery, clinicians can take steps to more carefully monitor high-risk patients and intervene before labor begins, after which, he said, there are few options for treatment.

Research has suggested that such interventions can prolong gestation by around 1.2 weeks, Critchfield said, adding that this saves health care costs by reducing the amount of time premature babies must be kept in neonatal intensive care units and by improving baby and child health in general.

Critchfield said that Sera has been discussing the test with payors for more than two years, seeking to lay the groundwork for its launch. "We have gone through the economics and modeled it very carefully with payors, and they understand the value proposition," he said.

Once the final validation data is in hand, Sera plans to "begin talking in earnest about getting coverage decisions and contracts with major payors," he said, adding that the company would start with a small targeted launch and then build out its sales force as it obtains coverage for the test.

Critchfield cited his experience at Myriad Genetics, where he served as president from 1998 to 2010, as a potential asset in terms of the PreTRM launch.

"I did this before at Myriad, and this is a similar type thing in many ways," he said. "You start with some key geographies, some early adopters that are involved in helping you generate data on how the test performs in actual practice, and then as the demand grows and people are aware of it you add the sales force."

Critchfield noted another potential similarity to his Myriad experience – the decision to make use of an emerging clinical technology, in the case of Sera, mass spec-based proteomics.

Because of its ability to provide both definitive identification of target molecules along with quantitative data and its potential for multiplexing, mass spec has for years been considered a technology well-suited to clinical proteomics. It has been bedeviled, however, by limitations in workflow throughput, sensitivity, and reproducibility.

In the last several years, however, many of these challenges have been overcome, and, with the 2013 launch of Indi's Xpresys Lung test, the technology officially made its way into the clinic.

It remains far from widespread, but, Critchfield said, just as the sequencing field experienced great leaps in practicability during his time at Myriad, mass spec-based clinical proteomics could see similar advances in the near term.

Upon launch of the test, Sera will be able to deliver results with a turnaround time of roughly a week. However, Critchfield said, the company is looking at various technologies "that will be able to significantly scale up throughput," and sees "a clear path" to doing so.

He noted that from the time Myriad first began its clinical sequencing efforts to 2006, it saw a 4,300-fold improvement in throughput. "I expect that mass spectrometry technologies will follow a similar pathway for improved throughput."

Using mass spec for clinical proteomic assays is attractive, Critchfield said, because the same analytic platform can be used for discovery, validation, and commercialization. The technology also holds out the possibility of more accurate measurements than immunoassays as well as the potential for lower costs through multiplexing.

He noted that the perception of mass spec as a clinical tool has changed in recent years, in part due to Indi's success with the technology. Critchfield is a member of Indi's board and Indi co-founder and board member Leroy Hood is a scientific advisor to Sera.

Sera also this week said it had appointed to its board Mansoor Raza Mirza, chief oncologist at Copenhagen University Hospital. Calling Mirza a talented clinical scientist, Critchfield said that he would be helpful to Sera's plans to ultimately expand intoEurope.

He said the company had no definitive timetable for moving into Europe, but that it would be providing information in upcoming months about its plans for this market.

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