New At-Home Prostate Cancer Diagnostic Test Breaks Down Barriers

By Matt Phillion

A new diagnostic at-home urinalysis kit, set to ease the struggle with patient compliance with prostate cancer screenings, can now be ordered by physicians, is available to patients, and eligible for Medicare reimbursement.

The kit, from Lynx Dx, works by analyzing the expression of 18 unique gene transcripts associated with prostate cancer. A recent study from the University of Michigan Medicine and Vanderbilt University Medical Center showed that MyProstateScore 2.0 (MPS2) significantly outperformed traditional prostate-specific antigen testing by identifying up to 53% of men whose biopsy would be negative, while maintaining a 91% to 94% sensitivity for high-grade cancer.

“The development of MPS2 has been a lengthy and diligent process,” says Spencer Heaton, MD, CMO of Lynx Dx. “The problem we’re trying to solve is that screening for prostate cancer has a really useful biomarker called PSA. It’s very useful in that most cancers don’t have something that you can get from a blood draw where you can get a marker and ask: what are your chances? Lung cancer doesn’t have this, for example.”

The problem, Heaton explains, is that PSA screening is recommended for all men at 45-50 years of age, and if it comes back elevated, you’re considered to be higher risk.

“There are a lot of reasons why our PSA could be elevated outside of cancer. It could be as simple as you went on a 30-minute bike ride the day before the blood draw, or it could be inflammation, an infection, sexual activity,” Heaton says. “You’ll get millions of men in the U.S. with an elevated PSA and a million of those men historically have been taken to a prostate biopsy to determine if their elevated PSA is because of cancer, and those biopsies are not fun. It’s not a pleasant experience, and there are lots of opportunities for infections and other side effects.”

The challenge here is that 80% of those biopsies come back as negative for clinically significant prostate cancer.

“So, what we’re trying to solve Is those 800,000 biopsies every year that come back negative. We’ve designed a test that can predict the likelihood your biopsy will come back negative with enough confidence you can defer the biopsy,” says Heaton.

Reasons patients avoid assessment

One of the challenges the MPS2 test recently overcame was that, if you are going to measure prostatic biomarkers, historically the most effective way to do that involves a digital rectal exam in which the physician manipulates the prostate to manually express some of the fluid.

“The big challenge for the last 20 years is that for all these urine-based tests, you have to convince the patient they need the exam, and people don’t like it. They don’t want to do it. It’s a huge barrier,” says Heaton. “But it was a necessary step to get enough prostatic fluid to get a good biomarker.”

Lynx Dx has spent years finding a way to not require that digital rectal exam.

“You can now just provide a urine sample, and more importantly, you can get that kit sent to your home,” Heaton says. “It blows the opportunity open for patient access.”

Their proprietary process looks at how strong a biomarker signal is, and they have reached the point where they can now get a better signal with the new test than previously was possible with the digital rectal exam.

“It’s not like we sacrificed some of the accuracy of the test to be more convenient,” says Heaton. “It’s actually more convenient and provides a stronger blueprint.”

Provider feedback has been strong, Heaton says.

“Physicians in this space are looking for tests that can accurately predict the risk of prostate cancer across all their patients, not just a few,” he says. “Some of the problems we’ve solved here have plagued this industry in the past. If you look at other tests performing a similar risk prediction, they all measure between one and four biomarkers, and we’ve expanded that panel to 18 biomarkers, and the test results are applicable across different populations.”

Physicians so far have gravitated toward the option to send the kit to the patient’s home, Heaton says.

“We’ve found exceptional patient compliance,” says Heaton. “Physicians are able to say, ‘Look, I’ll order a test. You don’t have to go to a special lab, you don’t have to get a blood draw. It just arrives at your house, and you provide a urine sample in a cup and FedEx will send it back to us.’ Men are willing to participate in this screening, which is the most important point here.”

The arguments for are often the arguments against

The arguments for a screening are often the same arguments men give to not participate, Heaton explains.

“You tell them you’ve got to get your PSA checked because if it’s elevated you might need a biopsy and they’ll say the last thing they want is a biopsy,” he says. “Imagine taking all of that out. If you’re low risk, you’re off the hook.”

Depending on the research, the rate of infections after a prostate cancer biopsy is anywhere from 5% to 7%, and some reports say 1% to 3% result in some form of hospitalization.

“This is a test that could avoid all of that risk, and you can do it from the comfort of your home,” says Heaton. “That’s the kind of breakthrough that can cause change at a larger scale.”

Prostate cancer is the second-most common cancer worldwide, and it becomes increasingly common as patients age.

“It’s hard for men to outlive the risk of prostate cancer. It gets bigger and bigger as you age, and dealing with this is a huge unmet need,” says Heaton.

Raising awareness

There’s a threefold need to raise awareness of the test, Heaton explains. Urologists and other providers, including the PCPs who refer patients to specialists, need to know the option exists. Lynx Dx will present at the American Urological Association this spring and continue to find other ways to reach that core audience.

They also know that there is an obligation to help patients understand what options are available to them.

“This can happen through patient safety and advocacy groups, men’s health organizations, and of course a large element in men’s health is that much of their care is managed through their partner,” says Heaton.

Lastly, it’s critical to gain the support of payers.

“Financial access is just as important as the tangible access,” says Heaton.

While patient care always comes first, there’s an opportunity to help lower healthcare costs as well through preventive care.

“It’s not often you have an opportunity to improve care and lower costs, but we can do that as the cost of our test is lower than a biopsy,” he explains.

Heaton says Lynx Dx hopes to see MPS2 become the standard rather than the exception when it comes to screening.

“The version of the test we can use at home has been on the market” since late February, Heaton says. “But ordering has exploded. If you step back and look at the country as a whole, it’s a lot of work to shift the standard of care. We want men everywhere—and the people who support the men in their lives—to understand what this is and when someone says what their prostate score is, to have that mean something to them.”

Matt Phillion is a freelance writer covering healthcare, cybersecurity, and more. He can be reached at matthew.phillion@gmail.com.