August 8, 2012

CardioDx has spent three years marketing a new genetic test that can tell when a patient’s chest pain is a sign of serious heart disease, or no big cause for alarm. It still has a long way to go before becoming part of mainstream medicine, but now the company has taken a big step ahead by persuading Medicare, the agency that provides health insurance to Americans over age 65, that its test is worth the money.

Palo Alto, CA-based CardioDx is announcing today that Palmetto GBA, the national contractor for Medicare, has agreed to reimburse the company for its Corus CAD test. CardioDx isn’t saying how much Medicare agreed to pay for the test, but it sells for a list price of $1,195 per patient, CEO David Levison says. The decision effectively means that more than 40 million Medicare patients are eligible for the test, as long as their doctor prescribes it.

CardioDx has spent three years marketing a new genetic test that can tell when a patient’s chest pain is a sign of serious heart disease, or no big cause for alarm. It still has a long way to go before becoming part of mainstream medicine, but now the company has taken a big step ahead by persuading Medicare, the agency that provides health insurance to Americans over age 65, that its test is worth the money.

Palo Alto, CA-based CardioDx is announcing today that Palmetto GBA, the national contractor for Medicare, has agreed to reimburse the company for its Corus CAD test. CardioDx isn’t saying how much Medicare agreed to pay for the test, but it sells for a list price of $1,195 per patient, CEO David Levison says. The decision effectively means that more than 40 million Medicare patients are eligible for the test, as long as their doctor prescribes it.

The CardioDx test, which I wrote about here in November, is attempting to blaze a new trail for molecular diagnostics for heart disease. The Corus CAD test takes a blood sample from a patient, analyzes the extent to which RNA from 23 genes is expressed in the blood, and that says in 72 hours whether a patient is at low risk of coronary artery disease. By using this kind of molecular diagnostic test in patients in non-emergency situations, CardioDx is hoping to help patients and doctors avoid some of the costly and invasive procedures currently used to suss out whether chest pain symptoms are a sign of a larger problem or not.

CardioDx has been marketing this test since June 2009 in a pretty limited way until now. The company has performed the test 30,000 times through a mixture of free offerings, patients paying for it out of their own pockets, or by case-by-case negotiations with private insurers, which Levison calls “hand-to-hand combat.” Winning Medicare reimbursement is a big step in smoothing out that process, which is important, because Medicare is the largest insurer of patients likely to demand the CardioDx product. It’s also important because Medicare’s actions are influential with private insurers.

“This is a very important milestone for the growth of the company. It clearly says our data package is sufficient for a major national payer to reimburse for it for tens of millions of covered lives,” Levison says. “It says the test has clinical utility, and is economically viable. We’ll leverage it.”

The market for a new coronary diagnostic like this is huge, although largely untapped. Heart disease is the leading cause of death in the U.S., and millions of people worry and wonder about whether they’ve got it every year. An estimated 9.2 million people underwent the current standard myocardial perfusion imaging tests in 2005, usually after reporting chest pain, CardioDx says. Those tests typically cost about $800, and take about three hours to yield results. Last November, CardioDx released clinical results that showed its test was better at determining when patients complaining of chest pain don’t have coronary artery disease. The hope is that if doctors feel confident enough to rely on that kind of finding, they could help patients and insurers avoid costly and invasive catheter-based procedures.

CardioDx has fewer than 100 employees today, and a small sales force of 10, although it expects to build up its sales force following the Medicare approval, Levison says. The company isn’t profitable, but it is well-financed for this push, as it pulled in a $60 million equity financing in May 2011. Its backers include J.P. Morgan, Longitude Capital, Acadia Woods Partners, Kleiner, Perkins, Caufield & Byers, Mohr Davidow Ventures, TPG Biotech, Intel Capital, Pappas Ventures, DAG Ventures, Asset Management Group and GE Capital.

Getting Medicare to reimburse for the test is an important step for CardioDx’s effort to get cardiologists to start adopting the test, but there are other hurdles still to clear, says Eric Topol, the chief academic officer at Scripps Health in San Diego, and the lead investigator of a CardioDx trial called Predict.

“Reimbursement is part of the story. Another big part will be about whether cardiologists are willing to change their normal operating procedures,” Topol says. “And I emphasize procedures,” he says, because many cardiologists have deeply ingrained habits for diagnosing coronary artery disease through invasive procedures.

Although molecular diagnostics have made headway in oncology in recent years, it hasn’t caught on as quickly in cardiology, Topol says. One other company, Brisbane, CA-based XDx, has won Medicare approval for a molecular diagnostic of a heart-related ailment, but it’s focused on determining whether patients aren’t rejecting a transplanted heart.

Topol says he likes the way the CardioDx test can save time and money by enabling patients to forgo certain invasive tests. “If it comes out with a low score, the confidence level you’ll not miss someone is high. You will have done someone a great favor by not putting them through a heart [catheterization] test,” Topol says.

Topol says he isn’t aware of any competitor with any test like CardioDx’s in the works, and there’s a lot of potential for such a test. But it can’t answer every question a cardiologist or primary care physician might have about a heart patient, and while it will enable some patients to avoid invasive tests, it won’t replace them. “This is a really nice alternative, but whether it will be widely embraced is hard to predict. Reimbursement has been an issue until now,” Topol says.

CardioDx’s Levison acknowledged a slew of other challenges ahead. Private insurers will want to see a steady stream of data to show the test is effective, and save them money on unnecessary procedures in the short-term and long-term. Doctors will continue to have questions about which patients are right for the test, and which aren’t. And since chest pain is such a widespread symptom that masses of primary care doctors see every day, CardioDx has to get the word out about its test to a lot more than just a couple thousand thought-leading physicians like Topol. The company has been “cautious and deliberate” to not over-promote the product, Levison says, but now CardioDx intends to get the word out a little more now that it has the validation of Medicare under its belt. “This is what we were looking for,” he says.

Corus CAD Wins at the Edison Awards Gala; Awards Celebrate 25 Years of Honoring Innovators and Innovation

PALO ALTO, Calif. – April 30, 2012 – CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced that Corus® CAD has been honored as a gold winner in the Science & Medical category of the internationally-renowned 2012 Edison Awards. The awards, which were presented last week at a gala in New York, symbolize the innovation personified by Thomas Alva Edison, inspiring America’s drive to remain at the forefront of creativity and ingenuity in the global economy.

Click here to read the full press release.

 
November 15, 2011

Chest pain is one of the big reasons people go to the ER or to see their primary care doc. Often when people get there, it’s hard to tell who has serious heart disease or something less serious. Now Palo Alto, CA-based CardioDx is presenting study results that say its new blood test, in certain situations, can help doctors tell the difference.

CardioDx said today that its test, called Corus CAD, was more effective than standard imaging techniques in a study of 537 patients. The study found that the gene expression test, which relies on a blood sample, was better than standard myocardial perfusion imaging (MPI) at ruling out the patients who don’t have coronary artery disease. The results, from a study called Compass, are being presented today at the American Heart Association’s scientific sessions in Orlando, FL.

Chest pain is one of the big reasons people go to the ER or to see their primary care doc. Often when people get there, it’s hard to tell who has serious heart disease or something less serious. Now Palo Alto, CA-based CardioDx is presenting study results that say its new blood test, in certain situations, can help doctors tell the difference.

CardioDx said today that its test, called Corus CAD, was more effective than standard imaging techniques in a study of 537 patients. The study found that the gene expression test, which relies on a blood sample, was better than standard myocardial perfusion imaging (MPI) at ruling out the patients who don’t have coronary artery disease. The results, from a study called Compass, are being presented today at the American Heart Association’s scientific sessions in Orlando, FL.

The company is hoping that studies like this one will help convince doctors to start sending in samples into its lab for a new kind of gene expression test, in hopes of avoiding other expensive and invasive procedures that end up being a waste. And there’s a huge amount of waste in cardiology that doctors, patients, and insurers would like to reduce. Of 400,000 people studied who underwent elective angiographic procedures, almost two-thirds (62 percent) were found to have no coronary artery blockage, according to a separate analysis published last year in the New England Journal of Medicine. The CardioDx test won’t be able to eliminate all the unnecessary procedures, but it should be able to reduce them significantly when used in combination with other diagnostic tools.

“We now have a blood test for coronary artery disease, which we never had before,” said Gregory Thomas, a professor of medicine at UC Irvine, who’s presenting the results today in Orlando. “It’s not perfect, but it can provide a very powerful opportunity for physicians to evaluate patients who may have heart disease.”

Gregory Thomas

CardioDx is backed by a cast of big name investors, who are betting that this test will work its way into mainstream medical diagnosis, and that insurers will figure it’s worth the $1,195 price tag. CardioDx raised $60 million last May, and has raised cash from the likes of J.P. Morgan, Kleiner Perkins Caufield & Byers, Mohr Davidow Ventures, TPG Biotech, Intel Capital, Pappas Ventures, and GE Capital, among others. At the time of the May investment, CardioDx said its test had been used for 13,000 patients, and a company spokeswoman now says that figure has grown to 20,000.

The potential market for a new coronary diagnostic like this is huge—an estimated 9.2 million people underwent the standard MPI tests in 2005, CardioDx says. Those tests typically cost about $800, and take about three hours to yield results, Thomas says.

Today’s test results, for sure, will go toward helping the company make its case for broader adoption. Patients in the study were considered stable, but had symptoms suggesting they might have coronary artery disease—a warning sign for future heart attack or stroke. They gave blood samples for the CardioDx test, which analyzed the extent to which RNA from 23 genes was active or inactive. The patients then got the usual myocardial perfusion imaging (MPI). Both of those readouts were compared later with the gold standard diagnostic findings from invasive angiography or CT angiography.

Researchers found that the new test was superior to MPI in what’s known as negative predictive value, which helps doctors rule out coronary artery disease. The CardioDx test was able to rule out coronary artery disease 96 percent of the time, compared with 88 percent of the time for MPI imaging. The difference was statistically significant.

The CardioDx test separated patients into two categories—those with high or low probability of having coronary artery disease. Researchers found that 46 percent of patients had a low score, and 54 percent had a high score. The results meant the most for patients who have the low score, because for them, it means that 96 percent of the time they be confident they don’t have coronary artery disease, says CardioDx chief medical officer Mark Monane.

Still, there’s a fair bit of uncertainty among those with a high score. CardioDx suggests that those with a high score go on to get a follow-up MPI test, Monane says. By layering those two tests on top of each other, doctors can hope to weed out many more patients who would otherwise get unnecessary invasive coronary procedures, he says. Even so, by adding in the CardioDx test, a majority of patients (53 percent) are still expected to get invasive procedures when they don’t have coronary blockages, Monane says.

The CardioDx test has its limits. It can’t be used in emergency situations, because it only provides an answer in a 72-hour turnaround time from the company’s Palo Alto lab. It’s an open question whether in the real world, physicians who get a low score will trust the data, and forgo further tests that add costs. And it isn’t for patients with diabetes, who already have higher coronary risks, Monane says.

But today’s findings could help CardioDx appeal to a broad group of primary care physicians and cardiologists who are looking for ways to better diagnose chest pain in a convenient way.

“We think our test is validated, it’s easy to use, it’s a blood draw, it can be done immediately, and it doesn’t require people to go out and buy an expensive piece of equipment,” Monane says.

Thomas, who is presenting the results today at the American Heart Association meeting, said there is a lot of interest among his peers in the data. But it will take time before people start actually incorporating it into their practice. He isn’t sure whether it will reduce healthcare costs, because some doctors may like the technology enough to use it on broader groups of patients than intended. Further in the future, the technology could also find additional uses, like as a monitoring tool in clinical trials to see whether drugs like cholesterol-lowering statins are working or not, he said.

“Physicians will want to see other physicians using it, and want to see it embedded in clinical guidelines,” Thomas says. “This doesn’t change medicine tomorrow, but it’s one step in potentially changing heart care.”

Researchers report a key step for the first gene test aimed at reducing unnecessary angiograms — expensive and somewhat risky procedures that hundreds of thousands of Americans have each year to check for clogged arteries. Most of these exams, done in hospital cardiac catheterization labs, turn out negative.

GE Healthcare, the healthcare business of GE (NYSE: GE) and CardioDx, a pioneer in cardiovascular genomic diagnostics, announced today that the companies have entered into a strategic alliance to advance and co-develop diagnostic technologies to improve the care and management of patients with cardiovascular disease. Building on the alliance, the GE Healthymagination Fund (www.healthymaginationfund.com), a new equity fund that makes investments in highly promising healthcare technology companies, has invested $5 million in CardioDx as part of a Series D round that the fund is leading. The alliance between the two companies aligns with GE’s healthymagination initiative which focuses on reducing cost, increasing access and improving quality in healthcare. This marks the first investment for the HealthymaginationFund. Otherfinancialtermswerenotdisclosed.

 

March 1, 2010

CardioDx is one of several molecular diagnostics companies founded by a well-known trio of West Coast VCs to be fast finding itself in the spotlight.