Health officials investigate East Haven start-up COVID test maker
EAST HAVEN — As Connecticut works to increase coronavirus testing to meet explosive demand, 12-15 Molecular Diagnostics, located in an industrial area on Panagrossi Circle just off Commerce Street, would appear to have a sought-after product: an easy-to-administer, saliva-based test that delivers fast results.
Town officials see it as a local success story.
But the start-up company's bid to gain federal Food & Drug Administration approval for its rapid test hit at least a temporary stumbling block this week when a team from the state Department of Public Health showed up and demanded information regarding the company's testing protocols.
"They called it an inspection," said Raymond G. Baldwin Jr., the town's interim chief administrative officer and director of economic development. "From what I gather, they told them to cease their operation until they could complete their investigation.
"There was no involvement or notification of anyone from the town of East Haven," other than some police officers who were dispatched to make sure everything was under control, Baldwin said.
The East Shore District Health Department also was not informed until after the fact, said Baldwin and East Shore Health Director Michael Pascucilla.
Pascucilla said that was unusual.
DPH spokesman Av Harris would not comment, except to say, "This matter is under investigation, so we cannot comment."
"DPH is a regulatory body that oversees licensed health care providers," Harris said. "We can do an inspection of a facility as part of an investigation."
12-15 Molecular Diagnostics President and CEO Saion Sinha, an expert in nanotechnology who is a professor of physics, biomedical and electrical engineering at University of New Haven, said the company is still operating while the investigation proceeds.
"We are not closed, but ... we are not offering any service to the general people," said Sinha.
"Unfortunately I can't tell you much," but "we are definitely cooperating with the Department of Public Health," Sinha said. "We apologize if there is any misunderstanding about it."
DPH "asked for information" and "we are working on getting it to them," he said.
The company was not yet officially offering testing services, Sinha said.
"We were gathering information for the FDA" filing, Sinha said. "We were not offering testing to the public. We were gathering data for our FDA approval process."
12-15 Molecular Diagnostics' patented "point of care" technology, which uses digital nanosensors to detect the virus, also can be used for other viruses besides COVID-19, Sinha said.
"Our test is very quick, it's very reliable. ... That's all true — and we have a lot of data to back it up, too," he said. "... You can test the saliva right in front of you," he said.
The company is very close to filing its FDA application, Sinha said. "We are working to get" FDA approval.
Baldwin said he and Mayor Joe Carfora visited the facility in September and "the director was very upfront that they were not yet FDA approved but were just gathering information. ... We didn't have any problems with their operations," Baldwin said.
In fact, Baldwin and Carfora both got tested there as part of the company's effort to gather information in advance of filing for FDA approval.
"They offered their services to our Fire Department, Police Department — and we availed ourselves of them," Baldwin said.
"Would we like to see them be successful? Absolutely," Baldwin said. "We would love to see them be successful — and we'd like to help them in any way that we can.
"We'd be honored to have a company that was at the vanguard" of keeping people safe from COVID-19 in East Haven, he said.
Stories that may interest you
New Hampshire school districts are losing money because the state’s funding formula is based on metrics heavily affected by the coronavirus pandemic
The alleged ringleader of a group accused of stealing about $700,000 worth of excavators, boats, personal watercraft, all-terrain vehicles, and trailers from dealers in four New England states has been captured in Florida
Police in Connecticut say a 17-year-old boy shot to death in Waterbury was one of several teens who tried to rob another youth, who opened fire at his attackers
All of our stories about the coronavirus are being provided free of charge as a service to the public. You can find all of our stories here.
You can support local journalism by subscribing to The Day.