Solomon Moshkevich, VP of marketing and business development at prenatal gene-testing startup Natera, has a simple advice for those seeking to commercialize products overseas, especially in emerging markets like BRIC nations.
Don't believe everything you hear when it comes to regulations overseas.
Natera, based in San Carlos, California, has developed the Panorama non-invasive test for prenatal test using DNA fragments that is far accurate than the conventional blood screening to search for chromosomal disorders like Down Syndrome and others. Because the test uses fetal DNA found in maternal blood, it is non-invasive compared to amniocentesis and other invasive screening methods, which have a potential for miscarriage. The company does other kinds of tests too including miscarriage testing and genetic carrier screening.
The company has a CLIA-certified lab in California where tissue and blood samples are sent for the testing, but when executives went to countries like Brazil, Russia and India, they were met with the same response. They needed to have an IVD strategy - in other words, the tests needed to be run locally at a hospital or lab.
“Here’s the story,” Moshkevich said in a recent phone interview. “When you go in at first, everybody wants to do the test by themselves. They want tech transfer to the local countries, but in fact the only country where that is necessary is China. China does not allow the export of blood or any tissue samples unless it is for specific research purposes that have been approved. When you first walk in to Brazil, Russia and India, they tell you the same thing, but it is not true. It is complex and you have to overcome these logistical hurdles but when the demand is strong enough and the product is strong enough like Panorama is, people find a way to deal with the logistical complexities.”
In August, Natera announced that it was partnering with DASA Group, a large diagnostic and clinical analysis lab in Brazil, to offer the Panorama test. DASA would collect the blood samples and sent them to Natera’s lab Stateside.
Natera has partnerships with other Brazilian labs and hospitals as well. The company sends collection supplies to these locations where they are used to collect the blood sample before being returned to the U.S.
“They are a box and special glass tubes which can preserve the fetal DNA that’s found in the maternal blood (of pregnant women who are at least nine weeks pregnant),” Moshkevich explained. “These tubes are not available in Europe, or Russia and Brazil.”
Currently the test costs about $1,000 in Brazil and Russia, where reimbursement isn’t yet available, and customers pay out of pocket, he said.
“If you give a woman a choice to have a non-invasive totally risk-free blood test at nine weeks pregnancy which is like the earliest they can ever do and to give a sensitivity of over 99% for trisomy 21, trisomy 18, trisomy 13 and ... it’s unheard of. People are lining up to pay 1000 out of pocket," he declared.
Eventually, though, the goal is to approach insurance companies and government to have some coverage in place.
“$1,000 is expensive for a lot of people,” he said. “Our initiative as a company is to improve families’ chances of to have healthy children around the world and to increase access to this technology. So we don’t want to keep this for people who can afford a $1,000 test….but it will take time.”
In the U.S., multiple insurance companies - Aetna, Cigna,- have issued positive coverage decisions, he said.
Regardless of the state of reimbursement, however, the bigger lesson for Natera is that you don’t have to set up a lab in Brazil, Russia and India in order to offer the test.
Like in Brazil, Natera has partnerships in Russia. Local partners include Mother and Child (also known as the MD Medical Group), a woman’s health company to offer its test. The company expects to launch its prenatal test in India soon after realizing that companies like Quest Diagnostics have daily airlifts from that south Asian nation.
But in the future, Natera believes it will offer testing locally because most countries will not want to reimburse a company that has foreign labs.
“It’s going to be critical for us to enable our partners to run the test in its own lab. In order to do that, we have to make the shift from a CLIA lab into an IVD distributor," Moshkevich said.
That might be prudent even in the U.S., as some FDA-exempt labs are coming under the agency's scrutiny.
Identifying and overcoming regulatory challenges in BRIC nations will be a topic of discussion at the IVD Business Strategy Conference in San Diego, Nov. 6-8. The event is being hosted by the publisher of MD+DI.
Correction: An earlier version of the story misspelled Moshkevich's name.