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'DNA Day' planned for Ravens' game undergoes federal and state scrutiny

A Massachusetts biotech firm still intends to give away DNA test kits to fans at a Ravens game this season, according to the team, but the promotion first must undergo scrutiny from a federal agency and the state.

The “DNA Day” event, scheduled for last Sunday’s Ravens-Cleveland Browns game at M&T Bank Stadium, was postponed after the federal Centers for Medicare & Medicaid Services raised questions with the state about approvals, state and federal officials said.

The federal agency said Monday that Boston-based Orig3n may be required to obtain federal certification to conduct such testing.

The agency, part of the U.S. Department of Health and Human Services, said in a statement that it is “working to determine whether any of the testing being offered by Orig3n is subject to the requirements of the Clinical Laboratory Improvement Amendments of 1988,” which include standards for laboratory testing of humans.

Orig3N, a new Ravens sponsor this season, had billed Sunday’s event as an opportunity for tens of thousands of fans to learn about their genetic makeup. Fans attending the game were to receive test kits and, if they chose to participate, swab the inside of their cheek, drop the sample into a bin at the stadium and register with the company online to receive a free analysis.

The value of direct-to-consumer genetic testing is the subject of scientific debate, and some organizations say the mass collection of DNA samples also raises privacy concerns.

Orig3n chief operating officer Kate Blanchard calls DNA “one of many important things you can know about yourself, no different than a scale to measure your weight or a cuff to measure your blood pressure.”

The Maryland Department of Health said Monday it is looking at Orig3n’s plans.

“There are pertinent state laws as well,” said Brittany Fowler, a department spokeswoman. “While the matter could not be remedied in time for (Sunday’s) game, the state health department is working with both the Ravens and Orig3n collaboratively to help resolve this issue.”

Direct-to-consumer lab testing is generally prohibited in Maryland. Genetic testing is permitted when ordered by a physician or other authorized person and conducted by approved labs.

Orig3n’s event has not been scrapped, a Ravens’ spokesman said Monday.

Orig3n “is working with the Maryland Department of Health,” team spokesman Kevin Byrne said. “Orig3n is confident it can receive the proper approvals and plans to have a fan giveaway later this season at one of our games.”

In a statement on Sunday, Orig3n also said DNA Day will be rescheduled.

“We are working to address questions from officials from the state of Maryland,” the statement said. “We received an overwhelmingly positive response to the first-ever DNA Day, and we remain committed to our mission.”

An outside spokeswoman working with Orig3n indicated the company would have no further comment on Monday.

jebarker@baltsun.com

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