When LabCorp announced an expanded range of genetic testing for breast cancer, one question immediately popped up: How does what LabCorp’s offering differ from self-administered 23andMe tests that the FDA cracked down on last week?

Burlington-based LabCorp cites several major differences.

In response to a query from WRALTechWire, F. Samuel Eberts III, the firm’s chief legal officer and senior vice president of corporate affairs, responded:

“Thank you for your inquiry regarding our new test offering of BRCAssure breast cancer mutation tests.

“The BRCAssure tests are not direct-to-consumer tests, but rather offered to physicians to order for their patients if clinically appropriate.

“In conjunction with the physician-ordered tests, LabCorp also has 145 genetic counselors on staff, offering the broadest team of professionals trained to analyze, assess and interpret genetic test results.”

LabCorp is targeting BRCA1 and BRCA2 genetic mutations.

Genetic tests for cancer and other ailments are becoming more common almost on a daily basis. But last week, the Food and Drug Administration lowered the boom on 23andMe, which is backed by Google.

As WRALTechWire reported:

“23andMe, the Google-backed DNA analysis company co-founded by Anne Wojcicki, was told by U.S. regulators to halt sales of its main product because it’s being sold without “marketing clearance or approval.”

“The Saliva Collection Kit and Personal Genome Service, or PGS, tells users whether they carry a disease, are at risk of a disease and would respond to a drug. Most of the uses fall into the category of a medical device and require Food and Drug Administration approval, the agency told the California-based company in a Nov. 22 letter made public today.

“The FDA said the company has failed to show that the technology is supported by science.”

LabCorp noted in its announcement that it has been involved in genetic testing AND counseling “for more than 25 years.”

And as Eberts pointed out: The tests are physician ordered

The FDA smack-down of 23andMe has likely sparked a lot of concern about the genetic testing business even as Angelina Jolie’s own remarkable decision to have surgery based on her own risk of cancer based on genetics raised awareness of the issue.

LabCorp;s latest series of tests are designed to help screen for breast, ovarian and other cancers.

No doubt, this is serious, serious business.

“The vast majority of individuals with hereditary breast and ovarian cancer syndrome, as well as a significant percentage of all diagnosed breast cancers, exhibit mutations in the BRCA1 and BRCA2 genes. In addition, men and women with mutations in BRCA1 or BRCA2 may also have increased risk of other cancers, including pancreatic, prostate, melanoma, stomach, esophageal and bile duct cancers,” LabCorp noted.

However, the company insists tests will involve “full gene sequencing” and supported by “145 genetic counselors.”

“The National Comprehensive Cancer Network and the American College of Obstetricians and Gynecologists recognize the importance of screening for BRCA 1 and BRCA2 mutations, and LabCorp’s BRCAssure panels will make this testing more available,” said Dr. Mark Brecher, LabCorp’s chief medical officer, in announcing additional tests. “LabCorp’s comprehensive, full gene sequencing BRCAssure tests will give healthcare providers the mutation information necessary to assist in patient counseling.”