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NOWDx Focuses on On-Site Diagnosis

5 min read

Just inside the front door of NOWDiagnostics is a dog bed with a chew toy that is roughly the size of an elephant femur.

The owner of the chew toy bounds up to visitors: Annie, an overtly cheerful 7-month-old Irish wolfhound who belongs to NOWDiagnostics CEO Kevin Clark. Annie, after being petted partially in self-defense, soon lopes off through the office complex to make her rounds at the Springdale facility.

Don’t mistake the casualness of the greeting for a lack of seriousness at NOWDiagnostics. Clark and his staff of mostly Ph.D.-credentialed researchers are doing serious and potentially lifesaving work.

“I personally think this can save the health care industry billions of dollars,” Clark said. “It empowers people to make the right decision sooner, getting results faster and getting treatment started faster.”

NOWDiagnostics manufactures one-step medical diagnosis devices that can generate lab-quality results in minutes. Clark said the company has 36 products in its trademarked ADEXUSDx line in some stage of development for ailments ranging from heart attacks to sexually transmitted diseases.

In August, the company received FDA approval for its ADEXUSDx pregnancy test for use in clinics and hospitals in the United States. NOWDiagnostics has five other tests — two for cardiac markers and three for toxicology levels — that are approved for use in Europe as well.

The pregnancy test works with a drop of blood rather than urine and can detect HCG, the hormone produced after a fertilized egg implants in a woman’s uterus, as soon as two days after implantation. Clark said the results can be obtained in minutes and, because the test detects the hormone so early, without the false negatives associated with urine-based tests.

This is important for many medical reasons. Clark said hospitals and urgent-care clinics are required to test all admitted women of child-bearing age to check for possible pregnancies.

Sometimes these patients can’t cooperate with a urine test — after a traumatic injury that requires emergency care attention, for example — and urine tests, Clark said, don’t detect the pregnancy hormone as soon as two days after implantation. Clark, whose company had created the pregnancy test as a prototype, realized NOWDiagnostics could remedy that problem and got the FDA to fast-track the test’s approval.

“Articles began coming out about problems in emergency rooms about false negatives; it’s a really high number of false negatives in the emergency rooms,” Clark said. “You can understand the liability. When I talk to the emergency room doctors, they say, ‘If you can save me the 20 minutes I have to wait for someone to go pee in a cup, it’s worth an enormous amount.’ That emergency room bed is worth thousands of dollars per minute to them.

“If you think about the average emergency room based on a 300-bed hospital, they’re probably seeing anywhere from 35-100 women for every eight-hour shift. Every woman that has ovaries they test.”

NOWDiagnostics works with state clinics and researchers to test the products. Pete Kohler, the vice chancellor at the University of Arkansas for Medical Sciences Northwest Campus, said the prospect of a near-immediate diagnosis would be a boon for medical professionals.

“I think there is a huge opportunity to be able to quickly get results that now take too long to get back,” Kohler said. “When you see someone in the clinic, what you want is instant lab results. There is usually some delay. The results get sent out and you get them a couple days later and then you follow up with a patient.”

Clark said eventually the company will market the pregnancy test for over-the-counter sales, which he said is an $890 million market annually. Gaining OTC approval would require a ramping up of production at NOWDiagnostics’ facility; Clark said the company would need about $3 million to buy the automation equipment.

Right now, the manufacturing is done by the company’s staff. Once a week, each researcher on staff pitches in for a day to help assemble the test devices, Clark said.

It’s a three-day process to assemble a batch of 10,000 devices, Clark said. The plastic is made in Osceola, and the casings are assembled by PolyTech Plastic Molding in Prairie Grove, which delivers the cases to Springdale.

Clark’s team then painstakingly prints the testing strips, marker line by marker line, drying each before proceeding. When the strips are finished, they are inserted in the plastic casings, labeled and packaged in a low-humidity room until shipment.

“When we need to do a batch, everybody pitches in,” Clark said. “When we get to full manufacturing and sales ramp up, we’ll have to start bringing in those workers. If this thing really takes off and we get to the OTC market, we’ll need 75 or so employees.”

The company recently raised $10 million in funding, part of which it used to buy ZBx Corp. of Toronto, which developed the technology used in the tests. Clark said owning ZBx allows NOWDiagnostics to control the scope and pace of product development.

The money raised will also provide operating capital for the next two years. In late October, NOWDiagnostics hired a full-time CFO, director of sales and director of finance.

Before the hiring of three executives, Clark said, the company had 17 employees who earned an average salary of $70,000. When he advertised earlier this year for 10 positions, he received more than 200 applicants.

“We’re really excited about it,” Clark said. “Now I can focus [ZBx] on our priorities, the 36 products that we want. Their job is to deliver me a prototype, and our scientists here run it through the FDA process.”

Kohler spoke of how useful the tests could be in a clinical setting, but Clark believes they will be equally beneficial for families. Sure, cardiac tests — which determine if a person has or is having a heart attack — may not be used by Mom, but the tests for strep throat or the flu or mononucleosis would be.

All those tests are currently in development at NOWDiagnostics, Clark said. He said it is part of the company’s envisioned Dr. Mom line of products, which would use saliva rather than blood.

“It’s all about empowering the caregiver to make the right decision, to have the knowledge to say, ‘Yes, I need to take my child to the doctor’s office,’” Clark said. “Now, the kid comes home with a sore throat, the mom has to take off work and take the child to the doctor, and they sit around in the doctor’s office with a bunch of sick kids. By the time they get home, they have strep throat. This keeps those people out who don’t need to go in and gets those people in there faster who do need to be there.”

Clark said he is always researching what other diseases can be tested with this technology. His wish list is malaria and dengue fever, two prolific killers worldwide.

“We’re learning more and more every day,” Clark said. “Every day we talk to hospitals we find out another test.”

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