Claritas Genomics
Claritas Genomics

Claritas Genomics, the genetic diagnostic lab spun out of Boston Children’s Hospital in 2013, has ceased operations.

Claritas’ demise was confirmed to Clinical OMICs by a spokeswoman for the New York State Department of Health, which had approved six of the company’s tests.

Jill Montag said Claritas contacted the Department by phone on Thursday to inform it of the shutdown; the Company was instructed to provide in writing the effective date of closure, the date that any final test reports would be issued, the location where records would be stored, and the name of a contact person who would be available to address any questions from patients.

“As of January 23, 2018, the Department has not received any written communication from Claritas Genomics,” Montag said. “Claritas Genomics did not indicate why they are ceasing operations. Claritas Genomics has not provided any specifics regarding the availability of the lab manager. The Department does not have any information pertaining to a company, institution, or entity that will continue the research and clinical work of Claritas.”

In the most recent approval, announced by Claritas on June 14, the New York State health department approved the company’s inherited Bone Marrow Failure, HLH/MAS, and Nephrotic Syndrome Regions of Interest tests; as well as the Claritas Clinical Exome companion Mitochondrial DNA analysis service.

In January 2017, the state health department approved Claritas’ Clinical Exome and Pediatric Neurology Region of Interest diagnostic tests. Earlier, the Department approved Claritas Clinical Exome, a first-line test for patients with complex, multi-systemic symptoms, and the Pediatric Neurology Regions of Interest test. 

The shutdown of Claritas was also discussed publicly in a LinkedIn post by the company’s former chief commercial offer, Patrick F. Terry, and in a published report, both on Friday.

“By 2018, the challenges of a competitive environment, third-party reimbursement headwinds, clumsy operational execution, difficulties associated with a diverse and misaligned investor group, along with the lack of high-caliber leadership spelled doom for the venture,” Terry stated.

Robert West, Ph.D., an emeritus professor at State University of New York Upstate Medical University, patient advocate and observer of personalized medicine developments, commented on Twitter that Claritas’ size was a challenge it could not overcome: “Competition, regulation, reimbursement- favors larger #genomics co.”

Neither Claritas’ client services unit nor Boston Children’s Hospital, which remained Claritas’ majority shareholder, responded at deadline to emailed queries from Clinical OMICs seeking additional information. Also not responding at deadline was WuXi NextCODE, which invested in Claritas’ $15 million Series B financing, completed in 2015.

Boston Children’s partnered with Life Technologies to form Claritas in January 2013, with the goal of using the company’s Ion Torrent sequencing technology to develop genetic and genomics-based pediatric diagnostic tests for inherited pediatric diseases.

The partners spun off the hospital’s genetic diagnostic lab less than a year after launching a collaboration designed to incorporate next-generation sequencing into their clinical workflow.

“The testing platform involved the use of two different types of capture methods and sequencing technologies— the Ion Proton (ThremoFisher) and MiSeq (Illumina),” Terry recalled. “Data from both platforms were merged and only variants seen by both were considered, providing orthogonal validation—the most informative exome available.”

“Boston Children's and Cincinnati Children's were Claritas' primary customers, though it had orders from over 100 other hospitals,” Terry added. 

According to Crunchbase, Claritas disclosed two financing rounds: One was the $15 million Series B, in which Wuxi NextCODE joined Series A round investors Boston Children's Hospital, Cerner Corp., and Cincinnati Children's Hospital Medical Center. According to Claritas’ LinkedIn profile, clinical experts from Cincinnati Children’s and Boston Children’s Hospital partnered with Claritas to develop its tests, which the company said numbered more than 100.

“Through the integration of market-leading sequencing platforms from Illumina and Life Technologies with Cerner’s laboratory operations, analysis and reporting solutions, we perform diagnostic testing designed to provide pediatric patients and their families with answers in weeks,” Claritas stated. “With our partner WuXi NextCODE, we have built the infrastructure, tools, and connectivity needed to bring patient information to the investigators who can use the information individually to care for a specific patient and in aggregate to discover correlations that lead to enhanced clinical trial design and new treatment development.”

The size of the Series A financing was not disclosed.

“They have a great idea of what they want to do but have struggled to implement a structured plan of how to get there,” an anonymous former employee wrote October 26, 2016, on the job and recruiting website Glassdoor.

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