What is Precision Medicine, and What Does it Mean for Your Clinical Laboratory?

The Benefits of
Precision Medicine

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How Your LIS Can Keep You Competitive

WHAT IS IT?

The medical field involves a surprising amount
of trial and error.

Will this treatment work for this patient? Why does that patient experience these symptoms? While medicine itself is deeply scientific and precision-oriented, the human body is far more complicated. Precision medicine emerged in response to those complications.

As precision healthcare gains more attention across the medical field, many clinical laboratory owners want to know what these new changes mean for them. In this post, you’ll find information on precision medicine, some important uses of precision medicine, and what these changes mean for you as a clinical laboratory owner.

What is Precision Medicine?

No two people’s bodies are exactly the same, so it stands to reason that people will react to medicines and treatments in different ways. While medical treatments can have broad, overall positive results, those results become varied when you examine the results in individual people and even in specific populations.

That’s where precision medicine comes in. Precision medicine is the practice of tailoring medical treatments to specific patients, keeping factors in mind like living conditions, lifestyle factors, and more. A person’s genetic makeup tends to play the biggest part in precision treatment.

This research is garnering a lot of positive buzz when it comes to cancer treatments, but it has multiple other medical applications, too. In fact, precision medicine was being used, to a certain degree, before researchers came up with a name for it. One of the most commonly cited examples is when doctors run a blood test before administering a blood transfusion. Matching the patient’s blood type to the correct transfusion is a form of precision medicine.

What is the Difference between Precision
Medicine and Personalized Medicine?

People sometimes use the terms “precision medicine” and “personalized medicine” interchangeably, but researchers tend to prefer the term “precision medicine” for the practice of tailoring medicine based on the subgroups that a patient belongs to. For instance, a doctor may prescribe a different asthma treatment to an African-American child than they would to a European-American child, based on data that says these children’s genetics may respond differently to different asthma treatment options.

“Personalized medicine” is an older term that some researchers avoid to prevent misunderstandings. Because the term may imply a tailored approach for each individual person, the medical community tends to say “precision medicine” instead.

The Benefits of Precision Medicine

Precision medicine has created a lot of excitement in the healthcare research realm, and it has provided some hope to patients with disorders that are difficult to treat. Researchers and doctors have observed several benefits of precision medicine, including the following.

Better Understanding of Diseases

First of all, precision medicine research can provide better understanding of disease in general. As researchers gain a closer look at genetic factors, they may discover new insights about what causes certain diseases, why some people are more likely than others to develop diseases, and what previously-overlooked factors may play a part.

From Treatment to Prevention

Again, most of the focus of precision medicine is on genetic factors. Precision medicine researchers look for genetic abnormalities that are linked to specific diseases. Thanks to this research, doctors can now treat many of the genetic abnormalities themselves instead of just treating the resulting disorders. This approach tackles the root of the problem, perhaps providing more effective treatments and even cures.

Furthermore, if doctors can treat the abnormalities before they result in diseases, they may prevent those diseases from emerging in the first place. At the very least, they may help their patients to lessen the severity of these diseases by taking a proactive approach.

One example of this proactive approach comes from certain breast cancer treatment drugs. Breast cancer has a strong genetic component, with a percentage of inherited breast cancer cases being linked to mutations in the BRCA1 and BRCA2 genes. Some breast cancer medications target these genetic abnormalities specifically.

Overlooked Treatment Applications

Precision medicine also opens doors into often-overlooked treatment possibilities. By understanding a patient’s genetic tendencies, doctors may notice potential treatment options that will respond better to that patient’s genetic makeup than more widely-used treatments.

Precision treatments and testing may also be applied when dealing with certain cancers or other disorders that resist traditional treatment methods.

Multifaceted Approaches for Complex Disorders

Some disorders, such as heart disease, are highly complex and include multiple factors. Because these disorders are so complex, they often demand a multifaceted treatment approach involving medication, different therapies, and day-to-day lifestyle changes.

However, not every medication, therapy, or lifestyle change will work in the same way for every patient. Precision healthcare can help doctors tailor their prescriptions and recommendations based on each patient’s background and situation, perhaps removing some of the guesswork from these already complex treatment programs.

Potential for Increased Medical Equity and the End of “One Size Fits All”

Precision medical treatments also bring the possibility of better equity in medical care. Generally speaking, medicines are developed, recommended, and prescribed based on how well they work for the average patient. However, thanks to certain biases in the American clinical research field, “average” tends to mean “white and male.”

American cancer drug trials, for example, generally include far more men than women, with breast cancer drug trials being the exception. For example, while women make up nearly half of lung cancer diagnoses, they make up less than a third of lung cancer clinical trial participants.

The problem with this disparity is that medications, in general, affect female bodies and male bodies differently. A drug that seems successful in clinical trials may only truly be successful in treating men, but doctors will still prescribe that medication to female patients who won’t see the same results. Likewise, a supposedly “unsuccessful” clinical trial may actually produce excellent results in majority female groups, and the bias toward male bodies may prevent women from receiving treatments that can work well for them.

Sex isn’t the only factor involved in clinical trial disparities. American clinical trials also lack representation among racial minorities. One ProPublica analysis found that clinical trials for cancer treatments often have little representation of Black patients, even when the cancer being studied disproportionately impacts Black people over other racial groups.

ProPublica gives the example of Ninlaro, a drug for the treatment of multiple myeloma. The drug was approved after a successful clinical trial. However, that clinical trial had a glaring issue:

One out of five people diagnosed with multiple myeloma in the U.S. is black, and African Americans are more than twice as likely as white Americans to be diagnosed with the blood cancer. Yet of the 722 participants in the trial, only 13 — or 1.8 percent — were black.

The study did not, therefore, examine whether Ninlaro may impact Black patients differently than white patients.

Just like sex-based underrepresentation, racial underrepresentation can keep some patients from getting the treatment that will work best for them. Overall, this “one-size-fits-all” approach to medicine doesn’t always work. The medical field needs more varied clinical studies to gain a more accurate perspective, and those variations should include the aforementioned factors as well as other underrepresented factors, like disability and sexual orientation.

Precision medicine may someday put an end to the “one size fits all” approach to healthcare. By taking genetic factors into account, it can provide more accurate predictions about which treatments will work best for specific patients. This approach will help doctors find the right treatments for their patients more quickly, and it will save many patients from the frustration of the “trial and error” method.

Cost Effectiveness in Healthcare

It’s no secret that Americans are struggling with the cost of healthcare. A portion of those costs comes from diagnostic testing, repeat doctor’s office visits, and switching medications when the previous medication doesn’t work.

Precision healthcare may help American patients cut back on those costs. When a patient leaves the doctor’s office, they are still expected to make their copay, whether or not they got any answers from the visit. They still have to pay for their medication, even if that medication doesn’t ultimately help them.

But what if those patients could receive an accurate diagnosis with fewer tests and office visits? What if they received the right treatment plan the first time, without all of the trial and error that sometimes comes with medical care? In this case, patients could spend far less money on copays and medications, and doctors could work more efficiently.

It’s a possibility with precision medicine. Precision healthcare can tell doctors how likely a patient is to have a specific disease or disorder. It reveals potential disorders that are rare in the general population but more common among specific subgroups. It can also help doctors figure out which medications are more likely to work for specific patients, depending on those patients’ genetics and environments.

Because precision healthcare can help provide more answers in fewer office visits, it can potentially decrease the burden of medical treatment costs.

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Precision Medicine Uses and Types

Up until this point, we’ve talked about precision medicine in a general sense, but what are some specific types of precision medicine? Below are some methods, uses, and initiatives involving precision healthcare. These uses give us a glimpse at how precision healthcare may impact the future of medicine.

The All of Us Initiative

An important initiative has emerged in precision healthcare: the All of Us Initiative, also called the Precision Medicine Initiative. This project is taking big steps toward more precise healthcare for patients.

The All of Us Initiative is a research program run by the National Institute of Health (NIH). President Barack Obama started the initiative in 2015. It’s an initiative based on overcoming the challenges listed above, specifically the challenge of going beyond the “average” patient. The program brings together volunteers from various races, backgrounds, genetics, abilities, and environments, and it uses information from those volunteers to build a database of genetic and healthcare information.

So far, the project has provided insights on genetic risk factors for diseases, treatment options for people who don’t fit the “average” patient mold, and technology innovations in healthcare treatment.

Examples of Precision Medicine

Precision healthcare has several categories and sub-categories. Researchers within all of these categories work together to create a more tailored approach to healthcare treatments. Here are a few examples.

Cancer Genomic Testing

In the past several years, genomic testing has made a big difference in cancer care. Now, not only can doctors examine the DNA of cancer patients, they can also run genomic tests on the cancer itself. As a matter of fact, this kind of genomic testing has become standard for certain cancers, including some breast cancers, colon cancer, and others. These tests can reveal the most effective treatment methods for those patients, increasing their chances of success.

Pharmacogenomics

Pharmacogenomics is important to precision medicine. Pharmacogenomics tests can reveal how a person’s body is likely to react to certain medications, based on their DNA. As these tests become more advanced and widespread, they can cut back on the “trial and error” approach to medication.

Pharmacogenomics may save time and money across several disease and disorder treatments. Consider certain mental health treatments, for example. With Major Depressive Disorder, for example, the current treatment practice is to prescribe a medication and monitor the patient’s progress to see if it works. If the medication does not work, then the doctor will prescribe a new medication, and the cycle will continue until something finally works.

“Most patients…don’t get full remission on the first medication they are put on,” said psychiatrist Sean Hood, as quoted by Rhiannon Shine in a piece for Australia’s ABC.

The process can become extremely frustrating to depressed patients who simply want to feel better, and considering the fact that antidepressants generally take 6 to 8 weeks to reach their full effect, this process can potentially last for years before a patient finally finds what works.

Pharmacogenomic testing, however, can cut through the trial and error process, helping patients find what works in fewer tries. Patients can save a lot of time, money, and frustration in the process.

Immunology

Immunological lab tests also have their place in precision medicine. These tests can detect blood types, pregnancy, disorders that impact the immune system, and even certain cancers.

Perhaps the most obvious connection between immunology and precision healthcare is the blood test. As mentioned, blood tests are one of the most common forms of precision health.

However, immunology could have other connections to precision medicine, too. Immunological tests can provide healthcare providers with a more complete profile of their patient’s immune system, helping them gauge potential adverse treatment reactions and tailor a healthcare plan based on immune responses. Together with pharmacology, immunology can remove much of the guesswork from the prescription process.

Precision Medicine and Clinical Laboratories:
How Your LIS Can Keep You Competitive

Of course, none of the above innovations would be possible at all without clinical laboratories, particularly molecular labs. These laboratories provide the DNA sequence tests that detect genetic abnormalities, determine a patient’s genetic makeup, and highlight the traits that can make a difference in the patient’s treatment plan.

If you own a molecular laboratory, you don’t have time to wait for your lab to catch up with the times, especially when it comes to precision medicine. Precision medicine is here now, and it’s here to stay. It shows no sign of slowing down. In fact, the precision medicine software market is expected to be worth $2.8 billion by 2027. Because clinical laboratories have an important part to play in these innovations, it’s important for laboratories to prepare themselves.

Clinical Laboratory Software Capabilities

Most importantly, clinical laboratories will need the right instrumentation, testing capabilities, and software. All of the following tests can make a difference for precision medicine purposes, so if you want your clinical laboratory to have its space in the precision healthcare world, then your software should be able to integrate with these tests:

  • DNA sequencing
  • PCR
  • FISH
  • Karyotyping
  • Immunology
  • Pharmacogenomics

Prepare for High Volumes

Your laboratory instrumentation and software should also be able to handle high volumes of tests. Whatever that means for your laboratory — whether it’s faster workflow support, highly organized batching, or whatever else it takes — you’ll want to make sure that your laboratory can keep up with demand.

As precision medicine’s capabilities grow, so will the demand for corresponding tests. The market is growing at a remarkable rate. Your laboratory should have the right supply to keep up with demand.

Comprehensive Reporting Capabilities and Fast Communication

Next, your software should have comprehensive reporting options that you can deliver in a fast, simple, and organized way.

Precision medicine has a lot of potential uses, and many of those uses involve treating very serious diseases and disorders. For example, oncology has seen some of the biggest advances in precision healthcare, particularly with cancers that can be harder to treat than others.

As a result, those who seek precision healthcare techniques will need their results and recommendations as quickly as possible. It’s important for doctors and patients to get some solid answers so that they can move on with definitive treatment plans.

The most in-demand labs, therefore, will be the labs that can provide fast, well-communicated results. Your clinical laboratory software can make a difference. The stronger its reporting capabilities, the more your lab will be empowered to communicate well with its clients.

Specimen Storage Management

For work with precision medicine, your laboratory software should include excellent specimen storage management. When it comes to running an effective laboratory, organization is key, and you’ll want your lab to be as effective as possible to stay competitive in precision healthcare testing. With the right specimen storage management capabilities, you should be able to locate and access specimens quickly.

nucleoLIS Ē.finity for Precision Medicine Laboratories

The nucleoLIS Ē.finity software is well suited for those who want to add a precision medicine focus to their laboratories. nucleoLIS Ē.finity includes all of the elements listed above and more for a well-organized genetic laboratory system.

Precision Workflow Automation

Psychē’s nucleoLIS Ē.finity comes with precision workflow automation, which makes a big difference for laboratories that take part in precision medicine testing. This automation lets you streamline your laboratory’s workflow, making tasks simpler and faster from one day to the next.

The streamlined automation also speeds things up by freeing your lab techs from busywork and smaller tasks. Those little tasks may not seem like much on their own, but they can interrupt flow, and the time that they take to accomplish can really add up. By moving these tasks out of the way, you empower your lab techs to focus on the more complex aspects of their work without interruption.

As a result, you’ll get your lab’s workflow moving quickly, which means that you can always deliver results on time. A timely lab is a preferred lab, and a preferred lab gets more business.

Customizable Report Formatting

nucleoLIS Ē.finity comes with several customization options. One of those options is in its customizable report formatting. Communication is vital to precision medicine, and your communication will work best if you can customize it to make it work for your laboratory.

Linking Complete Patient History

Because genetic history is so important to precision medicine, nucleoLIS Ē.finity lets you link to complete patient history, including familial relationships. This capability is a key component for precision medicine diagnostics and treatment recommendations. It provides more predictability for outcomes, which can translate to clearer answers for patients.

Contact Psychē Systems to Build Your LIS Today

nucleoLIS Ē.finity is quickly becoming the software of choice for laboratory owners invested in precision medicine.
From startup labs to major laboratory corporations, Psychē Systems has a host of laboratory software options to fit various needs.

If you have questions about how NucleoLIS
and precision medicine intersect, contact us.

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