Stillwater Medtech Firm Playing Key Role In Battle Against Spread Of Zika Virus

Diagnostic kit-maker DiaSorin tapped by U.S. to roll out test, process results.

Minnesota is emerging as a major player in the Obama administration’s efforts to control the spread of the Zika virus and to establish an emergency preparedness response to its potential public health threat.
 
The local piece of the story is the Stillwater manufacturing facility of the Italian biotech company DiaSorin S.p.A., which makes a crucial diagnostic test kit used for early detection of the virus. The company also makes an advanced, high-capacity analyzing system that can process up to 120 samples at a time and is capable of delivering the results within an hour.
 
The Stillwater biotech, located in a business park north of Hwy. 36, has roots going back to the mid-1970s when a former University of Minnesota professor founded a startup called Immuno Nuclear Corp. to manufacture diagnostic test kits for medical labs and hospitals. Now, 40 years later, its multinational owner is being counted on by the U.S. government to provide a first line of defense against Zika.
 
The World Health Organization is blaming the mosquito-borne virus for thousands of babies being born with microcephaly, a severe birth defect, and for some adults developing neurological conditions in Brazil and elsewhere.
 
President Barack Obama in February requested $1.9 billion in emergency funding to combat the spread of virus in the United States, but the U.S. Congress failed to agree on the proposal before its summer recess.  In response, Obama ordered the U.S. Department of Health and Human Services to repurpose $374 million from other programs to fund domestic Zika preparedness and response activities, even as reports of the virus emerged in Florida, Colorado, Mississippi and South Dakota.
 
HHS says that as of this month, it has allocated $231 million of that total, including $43 million directed to the Biomedical Advanced Research and Development Authority (BARDA) to develop Zika vaccinesdiagnosticsblood screening tests, and pathogen reduction technologies with private-sector partners such as DiaSorin.
 
BARDA announced last week that $2.6 million has gone to the company to “further develop a Zika virus test that may help physicians determine more quickly whether a patient was infected recently with Zika virus.” The tests are made to be processed in DiaSorin’s Liason XL high-throughput incubator/analyzer, which allows for continuous loading of blood samples and reagents.
 
“Such rapid, high capacity diagnostic tests are urgently needed in the global fight against Zika,” the BARDA announcement said.
 
The ability to process many blood samples is crucial because only one in five infected people ever exhibit any symptoms, and even those that do experience only a mild illness, thus it is necessary to carry out widespread screening even among people who feel healthy. BARDA said it favors DiaSorin’s test because it is serological, meaning it looks for early-response antibodies produced by the body’s anti-virus immune system.
 
The federal funding will go toward further developing the tests, which DiaSorin confirmed in a statement will indeed be produced in Stillwater. The funds will also be used for “manufacturing preparations and clinical trials that could support its application for FDA clearance.”
 
Company officials in Italy did not respond to inquiries seeking more information about the Minnesota facility, but Stillwater Community Development Director Bill Turnblad told TCB that as of 2010, DiaSorin (FTSE Italy: DIA) reported 250 employees working at the local facility. The multinational, headquartered in Saluggia, Italy, and with branches in the U.S., Germany and the United Kingdom, had 1,620 employees worldwide in 2014.
 
The history of the diagnostic kit-making business in Stillwater stretches back to 1975 when former U of M medical professor and Washington County resident Arnold Lindall founded Immuno Nuclear Corp there. Renamed Incstar Corp., it was credited with revolutionizing diagnostic testing, especially in the areas of reproductive and metabolic hormones, and with an IPO became a local stock star in the early 1980s.
 
But by 1987, flagging fortunes resulted in Lindall’s ouster from the company’s board. The Italian connection was forged two years later when Sorin Biomedia S.p.A. — then a subsidiary of the automaker Fiat — bought a controlling interest in the company. Shortly afterwards, Fiat divested Sorin and its diagnostic testing division, DiaSorin S.r.l.
 
In 1997, both Sorin and the remaining minority interest in Incstar were purchased by American Standard Corp. of New Jersey, the manufacturer of plumbing equipment, Trane air conditioners and auto brakes, in a deal worth $212 million. Incstar was delisted from the AMEX and its identity was subsumed by the DiaSorin brand.  
 
Its present ownership was established in 2000 when American Standard sold DiaSorin to a group of top managers: Carlo Rosa, Antonio Boniolo and Chen Even, who are still leading the company from Italy. The management buyout was financed by the private equity firm Iniziativa Piemonte of Turin, GE Capital Interbanca of Milan and the Italian manufacturing company SNIA.