Point-of-care diagnostic testing, as the name suggests, is designed to facilitate clinical decisions.
No where is it more important that in emergency rooms and intensive care units where being able to rapidly assess the condition of a patient may mean the difference between life and death.
Now, a Durham, North Carolina startup using protein-engineered technology developed at Duke University is trying to commercialize POCT tests that use sensors responsive to fluorescence. The technology is cheap and the test results rapid, which reduces the conventional laboratory process that takes about 30 minutes to a few seconds, says Lawrence Cohen, CEO of SenGenix.
And in both those respects, the SenGenix POCT tests are different from what is currently available on the market, Cohen declares.
“If a doctor is with a patient and he or she knows that the test is going to take minutes, he or she will go and see another patient and then come back; whereas, if it takes a few seconds, they will do the test,” he said. “That’s one thing. The other thing is cost.We are planning on something similar to a smartphone for the reader, which will cost under a $1,000 and the devices that are currently available are about $10,000, so it is going to be a tremendous cost advantage as well.
Currently, SenGenix is developing two tests: a kidney panel that can test creatinine levels, blood urea nitrogen (BUN) and potassium on a single test strip. The other is a basic metabolic panel that will testglucose, BUN, potassium, creatinine, sodium, chloride, CO2 and calcium, Cohen explained.
The first target will be hospitals. Later, Cohen wants to expand the number of tests offered — such as a lipid panel — which will make them more appropriate to a doctor’s office, for instance.
“Right now, we arefocusing on the hospital and areas within the hospital where actionable information is needed such as the ER, intensive care unit,” he said
A doctor at Duke University Hospital, Peter Kussin, said that by definition critical care units require rapid interventions, something that is not supported by conventional lab testing.
“Turnaround time for laboratory studies in a variety of critical or urgent settings can exceed one half hour,” Kussin said. He added that current point-of-care technologies are expensive. “The concept behind SenGenix is innovative and if realized, would address a critical need.”
To help commercialize that concept, SenGenix will be embarking on a series A fundraising round with a goal of raising $3 million by the end of the year.
Cohen said that although he will file for a 510(k), he expects to run three clinical tests in three locations enrolling 50 to 100 patients in each of them. He expects the trials to be completed within 60 to 90 days. He is also seeking a CLIA-waiver such that the tests can be done at the point-of-care and not a lab.
Cohen believes there is a real opportunity for SenGenix given the current focus on cost containment without sacrificing quality.
“Right now, what is on the market is about the same price as the reimbursement, so a lot of hospitals won’t adopt the point-of-care technology because economically it is not a good deal for them,” he said.
Succeeding of course means not only taking on the market leaders like Abbottbut other competitors like Epocal as well.
[Photo Credit: FreeDigitialPhotos.net]
By Arundhati Parmar
Arundhati Parmar is the Medical Devices Reporter at MedCity News. She has covered medical technology since 2008 and specialized in business journalism since 2001. Parmar has three degrees from three continents - a Bachelor of Arts in English from Jadavpur University, Kolkata, India; a Masters in English Literature from the University of Sydney, Australia and a Masters in Journalism from Northwestern University in Chicago. She has sworn never to enter a classroom again.More posts by Author
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