Category Archive: PGx

Posted by Teresa Becker on

Richard Roth’s Credentials:

Richard Roth has been working in the lab business since 2001, first with AmeriPath where he worked with GIs, OB gyns urologists, and oncologists. After 6 years at AmeriPath, Richard ventured into a water filtration company (yes, you read that right)! But Richard wanted to get back to the lab space, and missed having a direct impact on improving the patient care experience. This time, he wanted to focus on genetic testing. The term “personalized medicine” had just come about, and was gaining increasing popularity due to the positive effects genetics testing and personalized medicine was already having on patients.

Since then, Richard has now owned 2 PGx labs, both have since been sold. Now Richard and his wife, Christy, own a consulting company Roths Genetics Resources to help labs implement genetic testing in their current lab or help ambitious individuals build a new lab.

Richard’s Focus Areas:

“What I found when I started my first lab was that it was extremely difficult to find someone to help,” explained Richard. “I was in a brand new space and had little experience with the nuances of setting up a lab – especially a PGx lab. Even the manufacturers couldn’t help me and only had so much information to offer. And candidly, the information I did get from manufacturers was throw away – it didn’t help me at all.”

PGx Labs Face Difficulties With:

  1. Developing panels and chips by determining which genes and corresponding mutations to include
  2. Using translation software to interpret test results into an easy to read report that can be interpreted by the referring physician or group
  3. Advising on laboratory developed tests (LDTs), since sales reps and manufacturers can’t legally advise and cannot provide validation or methodology

What Does Your Consulting Practice Entail?

Because of all the moving parts a new lab (or existing lab that wants to get into PGx or more complex genomics testing), need a resource that can help them navigate the nuances and unknowns of starting or growing a lab. In as little as 6-8 weeks, Richard and Christy help PGx labs accomplish what would take months, if not a year on their own. They help labs with necessary steps, big and small:

  • Order equipment and supplies
  • Build out or design lab configuration
  • Develop panels for target markets such as cardiology, pain management, psychiatry, oncology and wellness
  • Validate methodology and tests to ensure analyzer consistency
  • Write protocols for analyzers
  • Quality control
  • Train staff on equipment
  • Hiring/staffing
  • Standard Operating Procedures (SOPs)
  • Initiate LIS through Pathagility
  • Develop patient education materials

Reimbursements: The Hottest Issue For PGx/Genomics Labs Today

A Brief Reimbursements History:

Prior to 2013, reimbursements used “Stacked Code”. With stacked codes, different Current Procedural Terminology (CPT) codes were designated to different parts of the testing process. In this scenario, the extraction of DNA was one code. The amplification was another code. And on and on.  By the time a sample was processed, multiple codes were billed totaling an exorbitant rate. Collectively, there needed to be a decision for how to proceed – another way to handle this issue.  Medicare vowed to modify the billing and reimbursements by the start of 2013, instead new CPT codes weren’t determined until October 2013.  From January to October, labs were not reimbursed by Medicare for PGx testing, causing some to go out of business.

Medicare and private insurances solution was to give a CPT code for each relevant gene tested.  In theory, that’s ok, but Richard explains one of the problems:

“If a lab tests 5 genes and each one has a CPT code associated with it, the reimbursements were so high that individuals with no knowledge of the industry cut corners and flooded the market like a gold rush to start labs and conduct genetic testing, all with the goal of making money from these tests. For example, CYP2D6 is a complex gene responsible for the metabolism of dozens of medications.  A lab could test CYP2D6 only running 2-3 mutations but getting reimbursed the same as a lab testing 17 mutations for the same gene.”

In Short, What’s the Issue With Reimbursements?

Eventually, Palmetto stopped reimbursing along with others (like Blue Cross). Too many labs were testing PGx and the reimbursements were too high for insurance providers to keep up. The problem is Medicare isn’t government run – it’s privately run – so they look at short term savings vs long term. According to Richard, “If you get the patient on the right medication the first time, it will cut costs in the long run (reduced Dr. visits, less money spent on medication, less testing, etc), but Medicare hasn’t looked at it that way.”

What Do You Think Will Happen to Reimbursements?

What the officials say is going to happen: in 2017, instead of a local coverage determination (LCD) where each MAC jurisdiction decides reimbursements, officials will unveil a national coverage determination (NCD). All will reimburse the same amount. From what Richard has heard, he believes this reimbursement will be around $300- $400 per test.

How Should PGx/Genomics Labs Prepare For the Future?

Labs that want to innovate and prepare for the future should look closely at the technology they are using. For instance, Richard explains that if your lab did sequencing 5 years ago, it would cost upwards of $1,000 per patient. Now, cost per test is way down because of technology advancements. If you run tests on an entire genome, the information that comes from the tests is days and days long. He explains that you have to have some sort of bioinformatic translational software that translates the data for desired testing result.

The PGx and genomics space is changing so fast and many more genes are constantly being identified . If you aren’t constantly researching and educating yourself, you are already behind.  It’s equally important to keep up on lab technology to help your lab improve efficiencies, quality, and positively affect the patient care experience, which is the entire reason for PGx and genomics testing in the first place. The patient should always, always be first.

 

 

Posted by Teresa Becker on

lab-test

A high volume clinical laboratory based in Louisiana specializes in advanced PGx and Toxicology testing. The lab receives test samples from around the United States to process in their CLIA certified lab.

Opportunity

With testing so sophisticated and unique, the lab needed a better way to provide clean and easy to interpret reports to referring physicians or groups that could be customized by case types, as well as branded to specific groups. The former LIMS system the lab used, which was an in-house system, was not able to expand with their growing testing capabilities and couldn’t meet the lab’s needs. The lab’s previous LIMS system also required a sizable IT team to support the system.

Solution

The team selected Pathagility as their new LIMS provider in the summer of 2015. Pathagility, which is a customizable laboratory reporting solution built to adapt across any type of test, device or laboratory, has the flexibility to serve the lab as the LIMS or Interpretive Reporting Software – or both. In partnership with Pathagility, the lab had the new platform in place and fully implemented in just over 2 months.

Results

The lab’s former in-house system was only able to analyze 50 tests across toxicology and PGx. With Pathagility, the lab is now able to analyze over 95 different tests – with the ability to analyze even more as the lab continues to expand testing.

The team is now able to format reports by any number of factors, including case types. Previously providing two separate reports to referring physicians and groups, Pathagility now allows the lab to create just one easy to interpret visual report. In addition, the team can now work alongside marketing to rapidly integrate unique logos and color for each group it serves for branding purposes.

Additionally, the lab’s administrators are able to track which staff member logged in to the Pathagility platform and are now able to track the actions of uniquely identified staff members with date and time stamps. Administrators can also monitor which actions were taken to create additional accountability and control across the lab for compliance purposes.

Download the entire case study to learn more about this high volume PGx lab and its results.


For more information on how your lab can prepare for tech advancements, check out these recent Pathagility resources:

How Top PGx Labs Are Utilizing Tech – And How to Keep Up

2016 Resolutions For the Advanced Laboratory

To learn more about how Pathagility can help your lab can keep up with the changing technology landscape, request a 30-minute demo.

 

 

Posted by Teresa Becker on

PGx Blog Image

Over the last 10 years, it has come to public knowledge that genes do not necessarily have to express themselves. Integrative doctors have brought to our patients’ attention that genes are turned on or off by our environment. Our environment includes the food we eat, the nutritional supplements we take, the thoughts we have, the exercise we do… Wow, the power of science!

What is Pharmacogenetics?

Pharmacogenetics is the study of how genes affect a person’s response to drugs. This relatively new field allows us to combine pharmacology and genomics to determine effective and safe medication dosages which are specific to an individual’s DNA makeup. This means minimizing side effects from the drugs! According to a recent article, at present there are over 770,000 injuries or deaths due to drug reactions per year in the United States. Pharmacogentics gives us the promise of significantly lowering this number.

In recent years, new technologies have emerged that can analyze DNA and see which biochemical pathways may be impaired, allowing  labs to cross-reference this with all the drugs that require that pathway to break them down. The laboratories then uses a LIMS system or reporting solution, like  Pathagility, to provide beautiful and, more importantly, comprehensible charts and reports that detail  which drugs a patient is able to break down in the normal fashion. These reports also provide insights into which drugs the individual will not be able to break down in the normal fashion.

The Future of PGx

Although pharmacogenomics has the potential to radically change the way healthcare is provided, it’s really only in its infancy. In the future, pharmacogenomics could find uses along the entire drug discovery and development timeline, beginning with target discovery late-stage clinical trials, according to a recent article. Beyond that, pharmacogenomic tests could eventually be used as an integral part of a routine visit to the doctor’s office as a means to get the right medicine to the right patient at the right time.

The Technology Behind PGx

Technology is  evolving to transform rapid genetic testing – especially in the advanced PGx labs. While portable devices are being engineered for robust diagnosis of disease that will improve patient experience and management, labs also see a great need for a superior, customizable laboratory reporting solution that can adapt across any type of test, device or laboratory. Often times, LIMS and reporting systems – especially those built in house – can be limiting to the types of tests they can analyze. PGx lab executives need a central laboratory reporting solution that will adapt across any type of test, device or laboratory to provide their lab, referring physicians and patients with the enhanced reporting that modern labs now require.

Today’s advanced labs need a platform that can easily integrate with their existing systems and interpret data from existing EMRs, LIMS, billing systems, lab instrumentation, and middleware systems; while affording them flexibility to report through multiple channels.

PGx Use Case

The lab’s former in-house system was only able to analyze 50 tests across toxicology and PGx. With Pathagility, the lab is now able to analyze over 95 different tests – with the ability to analyze even more as the lab continues to expand testing.

The team is now able to format reports by any number of factors, including case types. Previously providing two separate reports to referring physicians and groups, Pathagility now allows the lab to create just one easy to interpret visual report. In addition, the team can now work alongside marketing to rapidly integrate unique logos and color for each group it serves for branding purposes.

Additionally, the lab’s administrators are able to track which staff member logged in to the Pathagility platform and are now able to track the actions of uniquely identified staff members with date and time stamps. Administrators can also monitor which actions were taken to create additional accountability and control across the lab for compliance purposes.


For more information on how your lab can gain complete control, check out these recent Pathagility resources:

How Top PGx Labs Are Utilizing Tech – and How to Keep Up

Pathagility: Built For the Lab of Today

To learn more about how Pathagility can help your PGx lab can keep up with the changing technology landscape, request a 30-minute demo.

 

Posted by Teresa Becker on

You know just about everything there is to know about your lab. You understand the technology you use and how it works, you know each member of your staff and the roles they play, you know backwards and forwards all of the tests your lab equipment can read, and you can predict what TaT times are for each hour of the day. But for just a moment as you’re reading this post, forget everything you know about your medical lab. While you’re reading this post, you’re the patient. You’re the one that went to the your family physician and had important tests done earlier this week – blood work to determine why your body hasn’t been functioning properly the last couple months and why your medicines are reacting the way they are. You’re uneasy about the results, your family keeps asking if you’ve heard anything, and you’re anxious to get the tests back, whatever answers they may hold. You just want to know, and you want to feel better.

This scenario is an everyday occurrence for thousands of patients across the nation each day who have tests performed, for whatever the reasons may be. And they count on a series of events happening efficiently and effectively so they can determine what’s next, with the help of their referring physician.

Your lab, no matter your specialty, plays an integral role in the patient experience, whether you have direct interaction with the patient or not. So what can your lab do to directly improve the patient experience? Here are 3 ways:

  • Provide Referring Physicians or Groups With Intuitive Information

Your referring physicians see upwards of 10 patients a day – often times, even more than that. Because their time is in such demand, the more readable your reports and intuitive your data and results, the better your referring physicians will be able to help the patient. As a lab, you can create beautiful, easy to interpret reports by using a LIMS system like Pathagility that can help your lab determine the types of tests and reports you need and help determine the algorithms to process the interpretive reporting. Remember: the better the reports, the better the diagnosis or recommendation, and the more satisfied (and healthier!) the patient.

  • Improve Turnaround Times (TaTs) of Lab Tests

There’s nothing worse than getting lab work done and not hearing results back for days or weeks on end. What’s worse, when a patient calls their physician to find out, they are told they don’t have an answer and aren’t sure when they’ll hear. As a patient, you can relate to the frustration and fear that creates in the patient.

For your lab, you play an enormous part in improving this step in the patient experience, and ensuring all systems are integrated across your lab is a key element. As a lab executive, you need a central laboratory reporting solution (such as a LIMS) that will adapt across any type of test, device or laboratory. In addition, today’s advanced labs need a platform that can easily integrate with other existing systems such as EMRs, LIMS, billing systems, lab instruments, and middleware to ensure that all data is available in one single, secure location.

How does this affect the patient experience? When all lab data is stored in a central environment, it allows lab staff to act quickly and with supreme accuracy when creating reports or compiling data for referring physicians or groups. With fewer interruptions, lab staff can stay focused on the important tasks before them and ensure they are delivering the best information back to the referring physician or group, and thereby helping to answer the patient’s questions sooner and with more accuracy.

  • Create an Environment Where Everyone’s Voice is Heard

While you or your peers may oversee the entirety of lab operations and be responsible for quality and other measures, often times technicians and others working in the lab have firsthand insight into processes that can be optimized. In a lab where preciseness, quality, efficiency, volume, and timing all matter greatly, it’s important to find every area across lab operations that can be improved. And what better place to look for guidance than your employees?

Lab technicians, operations managers, and others in your lab may have valuable opinions and reasons to suggest new ways for your lab to do business. For example, perhaps one of your technicians notices that a step is being repeated and isn’t necessary. Or maybe the reports are created by your reporting solution, but aren’t delivered to the referring physician in the most timely manner. By allowing every lab employee to speak up and raise concerns or suggestions, you are empowering your lab staff, and thereby improving the end results for both referring physicians, as well as patients. And maybe even your lab’s own bottom line.


Without exception, labs should strive to ensure the patient remains the primary focus above all else, with the absolute goal of delivering premier care.

For more information on how your lab can gain complete control, check out these recent Pathagility resources:

The Evolution of the Lab

3 Ways Tox Labs Are Innovating

How Top PGx Labs Are Utilizing Tech – and How to Keep Up

To learn more about how Pathagility can help your lab establish best practices, request a 30-minute demo.

Posted by mark on

Spring is naturally a time to freshen up and start new things.  In that spirit, we are launching a fresh, new pathagility.com!  Our team is inspired by start-up labs and existing laboratories that are developing new tests.  We know how challenging it can be.  We love to help by providing a cost effective Software-as-a-Service that feels like a custom systemWhy Pathagility you ask?  Out of the box, Pathagility provides “Case Types” for Toxicology, Infectious Disease (IFD), Pharmacogenetic (PGx), Anatomic Pathology (AP), Women’s Health and other types of Molecular Diagnostic (MDx) testing.  Case Types represent the data management and report generation surrounding a particular type of lab test.  Custom case types can be developed to support more specialized, proprietary tests.  Oh, and the entire system (not just the lab report) can be custom branded because we KNOW branding is important to labs.  We hope you’ll check out how it works and discover that Pathagility has the flexibility to serve as the LIMS or Interpretive Reporting Software or BOTH.  Another item worth reading if you are developing a new lab test is this case study called LIMS + Interpretive Reporting for Personalize Medicine.

We certainly look forward to your feedback.  Let us know if you have questions; and as the days start getting a little longer, we hope you enjoy the freshness and newness of spring…

Posted by mark on

Over the past few weeks, Pathagility has been a part of several written pieces on the Pharmacogenetic (PGx) testing market.  We appreciate this coverage and continue to be excited about the healthcare benefits of PGx testing – and our role in it.  Below are links to some of the articles and blog postings…

ABpic

Pathagility Taking On Pharmacogenetics Market – Arkansas Business (Mark Carter)

Innovate Arkansas Blog – Pathagility’s PGx pivot really not a big one

KA+A Newsletter – Check out the cool things they’re working on

Kristian Andersen Big On Arkansas Startup Scene

Little Rock Firm Blazes Its Own PGx Testing Path