Just what the doctor ordered

By Chonglu Huang

Paul Lem (MD 2002) initially wasn’t that interested in going to medical school, despite the wishes of his traditional Chinese parents. As a kid, he dreamt of being an inventor, creating revolutionary new products that would carve out niche markets around the world.

Thus, it is both with fortune and irony that his medical education at the Faculty of Medicine, coupled with his fierce tenacity, propelled him and his Canadian biotech company—Spartan Bioscience—into the global forefront of personalized medicine, thanks to his invention of a rapid DNA diagnostic machine for on-site patient care.

This machine, called the Spartan RX CYP2C19 System, is a shoebox-sized rapid DNA testing device that detects genetic mutations that may hinder the effectiveness of widely prescribed drugs for treating stroke and heart attack patients upon arrival at the hospital.

Within 60 minutes through the use of a non-invasive cheek swab at the point-of-care, the Spartan device can determine whether a patient carries CYP2C19 genetic mutations, meaning that the person may not respond to 15% of all prescribed drugs, including antiplatelet drug therapy used for heart attack and stroke patients.

Gene variants such as these are proven to be present in about 30% of Caucasian persons and more than 50% of Asian and East Indian persons, leaving these populations more vulnerable to the chance that, if they were to have a heart attack or stroke, they would not respond to a commonly prescribed blood thinner.

“The groundbreaking trend with this DNA diagnostic device is that patients should now get the right kind of treatment for them,” says Dr. Lem, founder and CEO of Spartan Bioscience. “It’s no longer going to be acceptable for you to walk into a hospital and get the same treatment regardless of DNA, knowing that certain drugs don’t work for certain people.”

An international landmark trial backed by the Mayo Clinic

Already backed by regulatory approvals from FDA 510(k) in the United States and CE IVD Mark in Europe and with clearance in South Korea, Spartan RX has most recently acquired Health Canada’s approval as the first near-patient DNA test for personalized medicine for use by doctors, nurses, pharmacists and laboratory technicians.

Currently, over 24 medical care sites in the United States, South Korea and Canada are using the Spartan RX as part of a landmark clinical trial involving 5,270 patients sponsored by the Center for Individualized Medicine at the Mayo Clinic.

“This trial is to answer a very simple question,” says Dr. Lem. “What are your outcomes if you get standard treatment versus personalized treatment for heart attack or stroke? More specifically, what are the rates of deaths through stroke or heart attack versus getting personalized treatment, where the patients get a DNA test and drugs personalized to them?”

Dr. Lem and his team at Spartan Bioscience believe there will be a significant difference in results between the two groups. The trial—involving a number of major Canadian hospitals including the University of Ottawa Heart Institute, Toronto General Hospital, St. Michael’s Hospital, Sunnybrook Health Sciences Centre and the Montreal Heart Institute—is scheduled to end in 2016.

A major milestone for personalized medicine

“This is a major milestone for personalized medicine,” adds Dr. Lem. “With our Health Canada clearance, we also got approval to sell our devices not only to hospitals but also to pharmacies and doctor’s offices, where eventually people will be able to get their DNA results.”

Dr. Lem envisions home-based DNA diagnostic as the final frontier for his Spartan RX CYP2C19 invention.

“Everyone has been trying to achieve this since the start of the Human Genome Project,” he says. “The difficulty is to get the technology working accurately and to get the regulatory approvals.”

In evidence-based medicine, a landmark clinical trial that backs your product is critical to its mass uptake and industry standardization. Dr. Lem hopes that based on the results of the Mayo Clinic trial, the Spartan RX will become the gold standard application for post-stroke and heart attack treatment.

Inventing started in the labs at uOttawa

Despite attending medical school, following the advice of his parents, Dr. Lem continued to pursue his dream of being an inventor on the side. As a student, he would skip classes to go putter around at the University of Ottawa laboratories.

It was during one of these “personal learning sessions” that Dr. Lem thought of inventing a near-patient DNA diagnostic device.

“I spent a lot of time in the lab and saw that a lot of the equipment I used was big, bulky, slow, hard to use…yet very powerful,” he says. “We all know about the change from mainframe computers to personal computers. And home pregnancy tests, blood glucose meters—they all followed the same trajectory. I took note of this trend and ran with it.”

At age 26, he decided to take his fledging idea to Toronto to a business competition hosted by a venture capital firm, where he and his team ended up winning first prize and $1.2 million to start his first biotech company.

“I really believe this is the future, that DNA testing is going to be everywhere. I wanted to give it a shot. I want to look back at my life, and whether this works or not, I want to be able to say I worked on something worthwhile and cool.”

Main photo:
Dr. Paul Lem’s Spartan RX recently received Health Canada approval for use by health professionals and is currently involved in a clinical trial. Photo: Chonglu Huang