Illumina, Natera, Ariosa tests win contracts with CA's prenatal Dx program

Natera, Illumina's ($ILMN) Verinata Health and Ariosa Diagnostics have scored major deals to provide diagnostic testing to California women through the state's prenatal screening program, a coup opening the door to wider patient access in the nation's biggest state.

California recently added noninvasive prenatal testing to the program at no cost to patients, which has previously included genetic counseling, an ultrasound exam, amniocentesis and chorionic villus sampling.

Natera, a 2013 Fierce 15 company, said its Panorama diagnostic will become part of the program. Launched initially in March 2013, the blood test looks at cell-free DNA to screen for multiple chromosomal abnormalities. Verinata is adding its Verifi prenatal blood test, which screens for chromosomal abnormalities including trisomy 21 (Down syndrome) or trisomy 18 (Edwards syndrome). Ariosa Diagnostics disclosed that its Harmony prenatal test will now be available "in the majority of California's 28 comprehensive Prenatal Diagnosis Centers," also as part of the prenatal screening program.

The companies did not disclose financial terms, but the potential market is enormous. Verinata noted, for example, that California's prenatal screening program is the largest of its kind in the world and screens close to 400,000 women each year. Vance Vanier, Verinata's vice president of global commercial operations, pointed out that the state is also the first to make broad non-invasive prenatal testing a priority for high-risk pregnant women.

Natera CEO Matthew Rabinowitz said in a statement that the company had already signed agreements with nearly half of California's prenatal diagnosis centers, plus a large part of their satellite facilities. Natera has pushed aggressively to expand the reach of Panorama around the world, having signed distribution deals with Quest Diagnostics ($DGX), BioReference Laboratories and ARUP Laboratories, among others. This year, the company also attracted an impressive $54.6 million in venture funding to back its growth push.

Illumina grabbed Verinata Health earlier in 2013 for $350 million, and it has worked hard this year to expand the test's reach. Verifi can now be used on women who are pregnant with twins, for example. Verinata also won a clinical laboratory permit from the New York State Department of Health. Additionally, Teva ($TEVA) will now market the test in Israel.

Ariosa has also taken strides to promote its Harmony test, and recently won a major patent court battle against archrival Sequenom ($SQNM).

- read the Natera announcement
- here's the Illumina/Verinata release

Special Report: FierceMedicalDevices' 2013 Fierce 15 - Natera