Today, collecting a blood sample for testing typically requires a phlebotomist drawing blood from the patient with a needle at a lab or doctor's office, packing up and refrigerating the sample and shipping it overnight through the mail.
Howard Lee, the founder of Seroclinix, said he's come up with a cheaper and easier way to obtain samples for testing.
Patients using his system would prick their finger at home, or have that done at a pharmacy or clinic and place drops of blood on a card from a diagnostic kit. After that, they would just send the card through the mail in a return envelope to Seroclinix's lab in an Amherst office park.
Seroclinix would analyze the molecules found in as little as one drop of blood, or urine, using a process called mass spectrometry, for drug testing, hormone analysis and to help people better manage chronic diseases.
Lee said the same diagnostic technique could work on samples taken from animals and Seroclinix also will provide diagnostic lab services for veterinarians, farmers and breeders.
The Amherst testing and manufacturing space that opened last year received its license from the state Department of Health late last month. The company has started urine testing and expects to receive approval for blooding testing shortly, Lee said, with manufacturing of the test kits starting this summer.
Seroclinix started in Ontario. But Lee said he sees real potential for growth in the American marketplace, where spending on health care for humans and animals is much higher.
"There's no other market like this, in the world, in terms of the opportunity," Lee said in an interview. "This is where you have to be."
Lee founded Seroclinix in 2010 in Mississauga, Ont. Lee previously worked for ThermoFisher, overseeing its clinical division in Canada.
Seroclinix is his third startup, after he sold the first to ThermoFisher and the second to a private equity firm.
"We knew we wanted to be close to Toronto," Lee said.
He said a connection with Deborah Fritz brought Seroclinix to the Buffalo area.
They met on a conference call three years ago. Lee was so impressed with Fritz he convinced her to join Seroclinix as laboratory manager and relied on her to find the lab location.
It's a big commitment to join the first American outpost of a Canadian startup, Fritz conceded.
"I had faith," she said.
Seroclinix in January 2017 moved into 4,500 square feet of space in Zaepfel Development's Northpointe Commerce Park.
The company has spent its first years laying the groundwork for a new diagnostics and collection process that it says is easier and cheaper and just as effective as the standard process in use now.
Seroclinix can use the process to conduct diagnostics on urine samples collected from cows, horses, sheep and other animals to let their owners know the optimal time to breed them.
The company would use the same dry collection technology of drops on a card to test blood and urine samples from humans, without the needle and blood draw that can intimidate patients.
That would be an improvement from from traditional diagnostic methods, in which collecting the liquid and transporting the samples make up 20 percent to 30 percent of the cost. The U.S. Postal Service allows the cards to be sent through the mail, Lee said.
Technicians using a liquid chromatography/mass spectrometry machine can look at biological indicators in the drops of blood or urine to gain valuable insights in a patient's health, Lee said.
Lee said this "canary-in-the-coal-mine" testing could have a real benefit for people who otherwise would wait until it's too late to go to the hospital.
He said the technology would be used in drug testing, to ensure people with an addiction are complying with their treatment.
It also has potential for wellness testing and in assessing whether a patient's diabetes is under control.
And it is in the very early stages of development for the managing and early detection of neurological disorders, such as concussions and Alzheimer's disease, after patients compare their current state of health to a baseline reading. "It's a rapidly developing area," Lee said.
The company finished a 1,500-square-foot addition to its Amherst facility in November. Between its American and Canadian offices, Seroclinix employs about 15 workers and consultants.
Buffalo will serve as the American headquarters for Seroclinix, which has a partner facility in Dallas and is looking to expand overseas, Lee said.
Lee isn't the first entrepreneur to propose an easier way to collect samples from people. Elizabeth Holmes famously started Theranos on the promise of a pioneering new form of blood testing that only required a finger prick.
The company reached $9 billion in valuation before concerns about its technology, and failed federal lab inspections, put the company on the ropes.
Fritz and Lee said the difference between Theranos and Seroclinix is the well-established technology, including dry collection and mass spectrometry, used in Seroclinix's testing.
"If she had picked mass spec," Lee said, "she still would be a multibillionaire."