By JULIET PRESTON- Med City News, Jan 8,2018

It’s Sunday evening in San Francisco, the night before the madness that is the annual J.P. Morgan Healthcare conference begins.

I meet with a Genalyte representative in the Parc 55 hotel foyer as planned and she escorts me to a fourth-floor room. It’s a small space, but it’s filled with – among other things – two nurses in scrubs, one man in a lab coat, a new-age laboratory station, and a phlebotomy seat. Is this how AI is made? Are they going to remove my brain?

It’s an unusual set-up for JPM, but it’s undoubtedly the best way for Genalyte to show how fast and effective its technology has become. Members of the executive team will be meeting with investors (and the odd journo) over the next few days, drawing their blood and laying the groundwork for a new equity financing round.

It’s not a gimmick; the San Diego, California-based company has now spent 10 years developing its core lab-on-a-chip technology, readying it for blood-based analyses in a doctor’s clinic near you. It began with angel investors, then in late 2016, Genalyte closed a $36 million round led by Khosla Ventures and Redmile Group.

The idea is that, like the hotel room, a compact lab station could be set-up in an everyday healthcare practice. Patients going in for a routine appointment could then have their blood drawn as they get checked-in with the nurse. By the time the doctor is ready to see them, they have the results in-hand.

It’s easy to get excited about the possibilities, but with the rise and fall of Theranos, CEO Cary Gunn is particularly careful and considered. In a discussion after my blood draw, he said Genalyte is picking its battles. It’s sticking to tests that are already FDA-approved and it’s working within the current payment model.

“We wanted to work within the healthcare system,” Gunn assured.

The difference is that the test results are returned in as little as 15 minutes, not several days. Perhaps more importantly, the company’s Maverick Detection System disrupts the economics of blood work. Instead of selling the unit and the test kits, Genalyte has decided to offer its product as a service. And while standard laboratories run each test sequentially, Genalyte’s unit can do 30 at once. And it costs “millicents” to add another, Gunn added. It can even combine skills: In the hotel room, protein-based assays are run alongside complete blood counts, which literally counts different components of the blood, such as white blood cells.

Ultimately, patients may be able to routinely get 1,000 or more blood tests done as they wait to see the doctor. But would that be too much of a good thing? Excessive screening can cause false-positives and become a burden on the patient and the health system.

Gunn paints a different future, using prostate-specific antigen (PSA) tests as an example.

Men are typically tested at age 50. If it’s higher than ‘normal,’ they may be referred for a biopsy. However, what the doctor really wants to know is whether the patient’s PSA is elevated relative to their natural state, he said. If the patient has always had a high PSA, that’s their normal. It’s not a cause for concern.

On the other hand, someone with a very low PSA that shoots up to moderately-high in a short period of time should be investigated further. When handled correctly, with algorithms and automation, larger volumes of data can add clarity, not noise.

Does it work?
Theranos’s problem wasn’t its “vision.” It was that the technology didn’t stack up. So where does Genalyte stand?

Contributing writer Juliet Preston gets ready for a blood drawAfter I signed some consent forms on an iPad, one of the nurses drew a single vial of blood from my arm at 5:18 pm. The rest of the team and I chatted, then at 5:42 pm (24 minutes later), I got an email announcing that my test results were available. I logged in to my new portal and scrolled through the results of 34 tests with Genalyte’s Chief Medical Officer Rick Hockett (aka the man in the lab coat).

Everything was normal apart from my ‘mean corpuscular hemoglobin,’ which was flagged as high. What does that mean? Do I need something amputated? Am I going to die?

“What’s your diet like?” Hockett asked calmly. “Do you eat a lot of red meat?”

This particular blood test is influenced heavily by diet, he explained. My levels were marginally high and – truth be told – I was scarfing down carne asada tacos in Tijuana, Mexico, less than 24 hours before the test. So yes, that stacks up.

And therein lies the final lesson. As Genalyte President Kevin Lo pointed out, having a doctor on-hand when the test results come in means the patient doesn’t have time to unnecessarily freak out Googling what they might mean. For this reason, the company has no intention of putting the machines in pharmacies, despite the ease-of-use. It’s all about speed and efficiency. As far as healthcare goes, that’s plenty of disruption right there.

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