Spokane Journal of Business

PAML offers prenatal test to detect genetic concerns

Spokane-based diagnostics lab partners with Californiacompany for new screening

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Pathology Associates Medical Laboratories LLC, the Spokane-based diagnostics laboratory, says it has begun offering a new noninvasive prenatal test to check for genetic fetal abnormalities, such as the one that causes Down syndrome.

PAML says it's offering the test, marketed under the brand name verifi, through a partnership with Redwood City, Calif.-Verinata Health. The test, it says, can help detect the Down, Edward, and Patau syndromes, as well as sex chromosome abnormalities.

"It's the first test (PAML has offered) where we're able to analyze the baby's chromosomes without entering the womb," says Carmen L. Wiley, PAML's chief scientific officer.

Verifi is a blood test that analyzes genetic material naturally found in a pregnant woman's blood to detect the most common fetal chromosome irregularities. When ordered by a physician, the verifi test can be offered as early as 10 weeks into pregnancy to women at high risk of having a child with a disorder caused by an abnormal number of chromosomes.

The availability of the verifi prenatal test represents a major advance in prenatal testing by providing pregnant women with genetic information about their fetus without the risks associated with invasive testing, such as procedures known as amniocentesis or chorionic villus sampling, Wiley says.

The verifi prenatal test offers improved sensitivity and specificity over traditional screening methods, and for a majority of high-risk women it can provide reassurance that their fetuses aren't affected with the most common genetic abnormalities, Wiley says. In this laboratory context, sensitivity refers to the test's ability to measure true positive results, while specificity refers to its ability to measure true negative results, she says.

"We believe that by adding this test to our prenatal care regimen we will continue to provide the best patient care, minimizing the anxiety associated with the multistep prenatal screening process for our high-risk patients," she says.

PAML offers three other noninvasive prenatal serum tests, but they're made available to all women regardless of risk factors, whereas this one is not, Wiley says. Pregnant women who generally are considered to be at high risk are those over age 40 or who have had a child in the past with chromosomal abnormalities, she says.

Of the consideration that women give to whether or not to have such tests performed, she says, "It's a very personal choice. Some women will just have the test because they want to know if they're at risk."

The verifi prenatal test is covered as an in-network, contracted benefit by many health plans providers, Wiley says. Results are returned to the physician who ordered the test in three to six business days.

Wiley emphasizes that verifi is a screening test and doesn't replace invasive procedures, but says it could reduce the number of unnecessary invasive procedures performed.

Verinata Health's main focus is developing and offering noninvasive tests for early identification of fetal chromosomal abnormalities through its proprietary technologies. It is a wholly owned subsidiary of Illumina Inc., a San Diego-based company that describes itself as a "manufacturer and marketer of life science tools and integrated systems for large-scale analysis of genetic variation and function."

Illumina employs more than 2,500 people around the world and reported 2012 revenues of about $1.15 billion.

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