News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Recent Acquisitions by Roche Highlight the Importance of Structured Data and Concerns for Diagnostics Providers and Pathology Laboratories

Data generated by medical laboratories and diagnostic providers takes an increasing role in treatment and precision medicine and allows greater analysis of data and integration of data into the care process

Most anatomic pathologists recognize that the unstructured data that makes up most pathology reports also represents a barrier to more sophisticated use of the information in those pathology reports. One solution is for pathology groups to adopt synoptic reporting as a way to get a pathology report’s essential data into structured fields.

The healthcare marketplace recognizes the value of structured data. In 2012, venture capitalists funded a new company called Flatiron Health. Flatiron’s goal was to access the medical records of cancer patients specifically to extract the relevant—and generally unstructured—data and put it into a structured database. This structured database could then be used to support both research and clinical care for cancer patients.

How valuable is structured healthcare data? Just this February, Roche paid $1.9 billion to acquire Flatiron. At that point, Flatiron had assembled information about the health records of two million cancer patients.

But Roche (ROG.S), recognizing the value of data, was not done. In July, it entered into an agreement to pay $2.4 billion for the remaining shares of cancer-testing company Foundation Medicine that it did not own. Foundation Medicine sequences tumors and uses that genetic data to assist physicians in diagnosing cancer, making treatment decisions, and identifying cancer patients who qualify for specific clinical trials.

Anatomic pathologists play a central role in the diagnosis, treatment, and monitoring of cancer patients. It behooves the pathology profession to recognize that generating, storing, analyzing, and reporting the data generated from examinations of tumor biopsies is a critical success factor moving forward. Otherwise, other players and stakeholders will move past the pathology profession and stake their own claim to capturing, owning, and using that data to add value in patient care.

How Lack of Standards Impact Transfer of Patient Data

DATAMARK Inc., a business process outsourcing (BPO) company headquartered in El Paso, Texas, reports that analysts from Merrill Lynch, Gartner, and IBM estimate unstructured data comprises roughly 80% of the information in the average electronic medical record. This data could be the key to improving outcomes, tailoring precision medicine treatments, or early diagnosis of chronic diseases.

From narrative descriptions of biopsies to dictated entries surrounding preventative care appointments, these entries hold data that might have value but are difficult to collate, organize, or analyze using software or reporting tools.

To further complicate matters, each service provider in a patient’s chain of care might hold different standards or preferred methods for recording data.

“At this point, [standards] are not to a level that helps with the detailed clinical data that we need for the scientific questions we want to ask,” Nikhil Wagle, MD, Assistant Professor of Medicine, Dana-Farber Cancer Institute, Harvard Medical School, and Associate Member, Broad Institute, told the New York Times.

An oncologist at the Dana Farber Cancer Institute in Boston, Wagle and his colleagues are creating a database of metastatic breast cancer patients capable of linking medical records, treatments, and outcomes with their genetic backgrounds and the genetics of their tumors. Despite best efforts, they’ve only collected 450 records for 375 patients in 2.5 years.

Nikhil Wagle, MD

Nikhil Wagle, MD (above), Assistant Professor of Medicine, Dana-Farber Cancer Institute, Harvard Medical School, and Associate Member, Broad Institute, is building databases that link patient outcomes and experiences with their EHRs. But sharing that information has proved problematic, he told the New York Times. “Patients are incredibly engaged and excited,” he said, “[But] right now there isn’t a good solution. Even though the patients are saying, ‘I have consented for you to obtain my medical records,’ there is no good way to get them.” (Photo copyright: Dana-Farber Cancer Institute.)

Additionally, once records are obtained, the information—sometimes spanning hundreds of faxed pages—must still be processed into data compatible with Dana-Farber’s database. And updating and maintaining the database requires a full-time staff of experts that must review the information and accurately enter it as required.

When critical concerns arise—such as a cancer diagnosis—information that could yield valuable clues about treatment options and improve outcomes might be held in any number of data silos in any number of formats.

This doesn’t account for the complexity of organizing such information for researchers who are developing new treatments, applying data to less targeted approaches, or dealing with privacy concerns between care providers.

Moving forward, those who can create and interact with data in a way that requires minimal human touch to make it suitable for analysis, further processing, or archiving, could communicate data more effectively and glean value from the growing trove of data silos created by laboratories around the world.  

Big Pharma Making Big Bets on Structured Data

These are all the reasons why the recent moves by Roche show the importance and perceived value of structured medical records data as it takes an increasingly important role in precision medicine treatments and diagnosis.

With its acquisition of both Flatiron Health and Foundation Medicine, Roche has secured the ability to generate data, convert said data into a structured format to drive decisions, improve core data-related services, and promote the value of their offerings. This positions Roche to maximize the value of its data for internal use and marketing to researchers and other interested parties.

For clinical laboratories, pathology groups, and other diagnostics providers generating untold amounts of data daily, this highlights a critical opportunity to stay ahead of future trends and position themselves as valuable sources of information as healthcare data continues to play an essential role in modern healthcare.

—Jon Stone

Related Information:

New Cancer Treatments Lie Hidden under Mountains of Paperwork

Unstructured Data in Electronic Health Record Systems: Challenges and Solutions

Pharma Giant Roche Just Made a $2.4 Billion Bet on Cancer Data

Roche to Buy Flatiron Health for $1.9 Billion to Expand Cancer Care Portfolio

Why Drug Giant Roche’s $1.9 Billion Deal to Buy Data Startup Flatiron Health Matters

Roche Acquires the Outstanding Shares of Foundation Medicine for $2.4Bn

New Solutions for Unstructured Data May Help with Clinical Laboratory and Anatomic Pathology Data

Precision Medicine’s Most Successful Innovators to Speak in Nashville, including Vanderbilt Univ. Med. Center, Illumina, Geisinger Health, Northwell Health

Genetic testing, gene sequencing done by clinical laboratories and anatomic pathology groups underpin how first-mover hospitals, health networks are improving patient outcomes

In just a few weeks, an unprecedented gathering will bring together the nation’s most prominent first-mover health networks, hospitals, and companies operating programs that deliver precision medicine daily to patients in clinical care settings.

On Sept. 12-13, 2018, “Breakthroughs with Genetic and Precision Medicine: What All Health Network CEOs Need to Know,” will take place at the Hutton Hotel in Nashville, Tenn. “What differentiates these sessions is the emphasis on each organization’s strategy, how it launched its precision medicine programs, what is improving in patient outcomes, and how payers are reimbursing for these services,” stated Robert L. Michel, Executive Director of the Precision Medicine Institute in Austin, Texas. “This is not about the science of precision medicine. Rather, it is about the practical elements required for any hospital, health system, or physician group to actually set up and deliver a precision medicine service to patients on a daily basis.”

Precision Medicine’s First-Mover Hospitals and Providers to Speak

Health systems and hospitals headlining this special conference are:

Companies scheduled to present include:

  • Illumina;
  • Humana;
  • Sonic Healthcare USA;
  • Genome Medical;
  • CQuentia, and,
  • S. HealthTek.

Exhibitors include the above, plus: Thermo Fisher, Philips, Sunquest, and MyGenetx.

“This meeting will give you the insider’s understanding about delivering precision medicine in real patient care settings that cannot be accessed at other venues,” noted Michel. “The goal is to have first-mover providers share their experiences, thus providing a road map that other hospitals, physician practices, and other providers at this conference can take back and follow with confidence.”

Michel said that sessions will be dedicated to precision medicine strategies, how it is being used in oncology, primary care, the role of pharmacogenomics, and use of healthcare big data. Speakers will describe the clever ways innovative health networks and hospitals are using healthcare big data to inform physicians in ways that improve outcomes, lower the cost of care and, in two real-world case studies, are generating seven-figure reimbursement from shared savings programs with certain health plans.

This year’s keynote address is by Jeffrey R. Balser, MD, PhD (above), President and CEO, Vanderbilt University Medical Center and Dean of the Vanderbilt University School of Medicine, one of the most progressive and innovative health systems in the country. (Photo copyright: Vanderbilt University.)

Using Healthcare Big Data to Achieve Precision Medicine Success, Shared Savings

“Shared savings successes will be one of the breakthrough achievements reported at the Nashville event,” he explained. “We’ve invited two prominent provider organizations to share how they are using healthcare big data to support physicians in achieving improved patient outcomes while at the same time impressively reducing the overall cost of care. To my knowledge, this is the first time these precision medicine case studies have been presented at a national meeting.”

One such presentation will be delivered by Philip Chen, MD, PhD, Chief Healthcare Informatics Officer at Sonic Healthcare USA Austin, Texas. Their precision medicine goal was to use healthcare big data to help physicians better manage diabetes and other chronic conditions in their practices. This program involved a large primary care practice and a major health insurer. Now in its fourth year, Sonic Healthcare USA is earning six- and seven-figure payments as part of a shared savings arrangement with the insurer.

“Shared savings is definitely a Holy Grail for all large health networks and physician groups as payers drop fee-for-service and switch providers to value-based payments,” said Michel. “The experience of Sonic Healthcare in this innovative three-way collaboration with an insurer and a very large physician group demonstrates that a strong data analytics capability and engagement with physicians can simultaneously bend the cost-of-care-curve downward while improving patient outcomes, as measured year-by-year. This is a presentation every C-Suite executive should attend.

Strategic, Business, Operational, and Financial Aspects of Precision Medicine

“This conference—centered upon the strategic, business, operational, and financial aspects of a precision medicine program—came to be because it is the unmet need of every health network CEO and C-Suite administrator,” observed Michel. “Every healthcare leader tasked with developing an effective clinical and financial strategy for his or her institution knows that the real challenge in launching a precision medicine program for patient care is not the science.

“Rather, the true challenges come from how to support clinical needs with the availability of capital, recruiting experienced clinicians, and putting the right informatics capabilities in place,” he stated. “Most hospital and health network administrators recognize the risk of launching a precision medicine program too early. They know such programs can suck up huge amounts of resources without producing significant improvements in patient care. What adds to the risk is that payers may be slow to reimburse for precision medicine.”

Register today to guarantee your place at “Breakthroughs with Genetic and Precision Medicine: What All Health Network CEOs Need to Know,” (or copy and paste this URL in your browser: https://dark.regfox.com/precision-medicine-institute).

Register by September 1 and save $300 on tuition! Plus, take advantage of our special Team Discount Program, so you and your key team members can get the most out of the conference by attending together.

“Breakthroughs with Genetic and Precision Medicine: What All Health Network CEOs Need to Know” is the gold-standard summit for everyone active or interested in succeeding with precision medicine programs. Don’t miss out—register today!

—Michael McBride

Related Information:

Breakthroughs with Genetic and Precision Medicine: What All Health Network CEOs Need to Know—Full Agenda and Details

Breakthroughs with Genetic and Precision Medicine: What All Health Network CEOs Need to Know—Registration information

Ongoing Growth in Consumer Genetic Testing Pressures Hospitals, Healthcare Networks to Educate and Prepare Physicians

Syapse Creates Precision Medicine Council That Quickly Attracted 200 of the Biggest Hospitals and Health Networks as Members

When Ramping Up Genomic Programs, Health Network/Hospital CEOs and Executives Must Consider Emerging Technologies, Swiftly Rising Consumer Demand

Precision Medicine Success Hinges on Diagnostics’ Clinical Utility

Precision Medicine and Sharing Medical Data in Real Time: Opportunities and Barriers

Ongoing Growth in Volume of Clinical Laboratory Tests That Support Precision Medicine Due to Physician Acceptance; Payers Still Have Concerns

 

Biotech Entrepreneur Ready to Spend $100 Million to Design Cheap and Easy-to-Use Handheld Ultra-sound Scanners That Can be Used in Drugstores

Radiology poised to be disrupted as entrepreneurs work to create smaller, cheaper imaging devices that perform as well or better than big, expensive imaging systems

Handheld ultra-sound scanners that are as “cheap as a stethoscope” is the goal of a $100 million development project. Just as the clinical laboratory industry is seeing entrepreneurs pour hundreds of millions of dollars into projects intended to create miniature medical laboratory testing devices, so also is radiology and imaging a target for ambitious entrepreneurs.

The vision of biotechnology entrepreneur Jonathan Rothberg, Ph.D. is to have patients take a trip to their neighborhood drugstore rather than an imaging center the next time they need an ultrasound or MRI.

Rothberg is the driving force behind a $100 million startup called Butterfly Network. He hopes to disrupt the status quo in radiology by creating an ultrasound scanner that “is as cheap as a stethoscope” and would allow physicians or other healthcare professionals to do imaging studies using a device not much larger than a smartphone, MIT Technology Review reports. (more…)

Finding Genomes with ‘Knockout’ Genes Leads to Development of New Therapeutic Drugs, along with Clinical Laboratory Tests for these Biomarkers

Drugs based on knockout genes are expected to trigger the need for companion diagnostic tests that will be performed by pathologists and medical laboratory scientists

Pharmaceutical companies and other research programs are developing a new opportunity to use information from human genome sequencing to create a new class of therapeutic drugs. These drugs target “knockout genes” and those same genes are expected to be used as diagnostic biomarkers for clinical laboratory testing as a new field of companion diagnostics emerges.

In simplest terms, large-scale DNA sequencing of the human genome is enabling researchers to identify individuals with “knockout” genes and then develop therapeutic drugs based on that knowledge.

The first commercial success story from this partnership of geneticists and the pharmaceutical industry is expected to be a new class of drugs that lowers cholesterol. These drugs may reach pharmacy shelves this year, reported an October 24 Nature article. (more…)

New Medical Laboratory-in-a-Suitcase Detects Ebola in 15 Minutes or Less

Demand for a rapid, accurate diagnostic solution to combat Ebola is motivating research teams in many countries to develop solutions that can be put to immediate use

In West Africa, the outbreak of Ebola in several countries motivated researchers in Germany to develop a fast, accurate, and inexpensive test that could be performed in patient care settings without the need for a centralized medical laboratory.

In these West African countries, lack of electricity and reliable cold storage or diagnostic equipment handicaps clinical laboratory technicians who are testing patients for the Ebola virus. A new test developed by researchers at the German Primate Center (DPZ) in Göttingen, Germany, cuts the time to answer an Ebola diagnosis to just 15 minutes. It requires no electricity and is portable. Previously, the fastest Ebola diagnostics test took three hours to get results and required transporting samples to often-distant medical laboratories. (more…)

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