Mass. company wins FDA testing OK
Hologic gets go-ahead
The FDA has granted an emergency use authorization to a Marlboro company’s coronavirus testing machine that can crank out results in three hours — and it’s not made in China.
Hologic’s “Panther” molecular testing platform is the “gold standard” for detecting COVID-19, said Kevin Thornal, president of the company’s diagnostics division.
“Hospitals in Boston have it,” he told the Herald Friday. “This approval drastically increases testing throughout the United States — and we’re going to do more.”
The company has 1,000 Panther machines — each slightly larger than a wide refrigerator — in 50 states and 800 more around the world. The Panthers are made with some parts from Massachusetts and are built in California and Germany.
They are sold in China, but not made there in any manner, Thornal said declining to comment on calls to bring back production of medical equipment and computer chips to the U.S.
“Testing is the key and highly accurate testing is important,” Thornal said about states moving to reopen the economy. “Test results will help public health officials decide if someone should be quarantined or can get back to work.”
The company’s goal is to pump out 1 million test results nationwide in a week and keep building on that capability. Each Panther costs about $1,128 per 100 test kit unit, according to Hologic sales documentation.
Hologic Inc. stock climbed to nearly $52 a share Friday.
The Panther machine — that drills down to the molecular level to test for COVID-19 — went to market eight years ago to help doctors detect cervical cancer, HIV and sexually transmitted diseases. It’s been quickly equipped to hunt for the coronavirus now and has a success rate of 99+%, the company states.
“All the research and science behind this has allowed us to move more quickly,” said Thornal, who added the Chinese shared the COVID-19 genetic sequence with the world in early January, and in mid-March the first Panther test was conducted and then Friday the machine was cleared to hit a market starved for results, hitting the bullseye as far as meeting a need.
Both Gov. Charlie Baker of Massachusetts and President Trump have stressed that until a vaccine is ready, testing, contact tracing and isolating the sick at home will allow workers and businesses to head back outside again.
Hologic equipment comprises 20% of the 5,000 high-throughput testing machines in the U.S. – the largest molecular testing capacity of any company.