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Clinical Laboratories and Pathology Groups
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Clinical Laboratories and Pathology Groups
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Recent Acquisitions by Roche Highlight the Importance of Structured Data and Concerns for Diagnostics Providers and Pathology Laboratories

Aug 27, 2018 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Management & Operations, News From Dark Daily

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 Requires Targeted Cancer Therapies, but Payers Reluctant to Pay for Some Genetic Testing Needed to Match a Patient with Right Drug

Precision Medicine Requires Targeted Cancer Therapies, but Payers Reluctant to Pay for Some Genetic Testing Needed to Match a Patient with Right Drug

Jan 12, 2018 | Laboratory Pathology

Clinical labs and pathology groups know how advances in targeted therapies and genomics far outpace providers’ and patients’ ability to know how best to use and pay for them.

One fascinating development on the road to precision medicine is that many new cancer drugs now in clinical trials will require a companion genetic test to identify patients with tumors that will respond to a specific therapeutic drug.

This implies more genetic testing of tumors, a prospect that challenges both the Medicare program and private health insurers because they already struggle to cope with the flood of new genetic tests and molecular diagnostic assays. However, even as this genetic testing wave swamps payers, some pharmaceutical companies have cancer drugs for rare types of cancers and these companies would like to see more genetic testing of tumors.

Pathologists and clinical laboratory managers will find this to be precisely the dilemma facing specialty pharma company Loxo Oncology (NASDAQ:LOXO), a biopharmaceutical company located in San Francisco and Stamford, Conn.

Loxo is developing larotrectinib (LOXO-101), a “selective TRK inhibitor.” According to a Loxo press release, Larotrectinib is “a potent, oral, and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRK receptors).” In short, the drug is designed to “directly target TRK, and nothing else, turning off the signaling pathway that allows TRK fusion cancers to grow.”

How to Find Patients for This Cancer Drug

While a powerful, new, targeted cancer drug will be a boon to cancer therapy, it is only intended for a relatively small number of patients. Loxo estimates that between 1,500 and 5,000 cases of cancer are caused by TRK mutations in the United States each year. Conversely, according to the National Cancer Institute, the total number of new cancer diagnoses in the US in 2016 was 1,685,210.

An article in MIT Technology Review on larotrectinib notes, “To find patients, Loxo will need to convince more doctors to order comprehensive tests that screen multiple genes at once, including TRK.” And that is where things get complicated.

“These advanced genetic tests, which can cost $5,000 or more, are offered by companies like Foundation Medicine, Caris Life Sciences, and Cancer Genetics. The problem is, insurers still consider the tests ‘experimental’ and don’t routinely cover them, meaning patients are often stuck picking up the bill,” notes MIT Technology Review.

Data for the graph above comes from the National Human Genome Research Institute. The graph illustrates the steep decline in cost for whole genome sequencing over the past 17 years. As the cost of genetic testing drops, development of targeted-drug cancer therapies increases. Clinical laboratories and anatomic pathology groups can expect to be performing more such tests in the future. (Graphic copyright: National Human Genome Research Institute/Simple English Wiki.)

To further confuse the market, the National Cancer Institute states that “Insurance coverage of tumor DNA sequencing depends on your insurance provider and the type of cancer you have. Insurance providers typically cover a DNA sequencing test if there is sufficient evidence to support that the test is necessary to guide patient treatment. Tests without sufficient evidence to support their utility may be considered experimental and are likely not covered by insurance.”

Many reliable sources agree. For example, the US National Library of Medicine Genetics Home Reference states, “In many cases, health insurance plans will cover the costs of genetic testing when it is recommended by a person’s doctor.”

That, however, leads to a different conundrum for drug makers such as Loxo: the majority of doctors are not keeping up with the rapid-fire pace of discovery in the realm of genetics and targeted therapies. Some genes like BRCA1 and BRCA2 are familiar enough to doctors that they know how and why they are important. However, most other genes are less known, and critically, less understood by doctors who must also focus on all the other myriad aspects of patient care.

In an article on the Color Genomics $249 Hereditary Cancer Test, which tests for mutations in 30 genes, Timothy Hamill, MD, Professor Emeritus, University of California San Francisco (UCSF) Department of Laboratory Medicine, and former overall director of UCSF’s clinical laboratories, told Wired, “If you talk to docs, they say ‘BRCA, that’s the only thing I’m interested in because I don’t know what to do with the other information.’ Doctors don’t know what to do with it. Patients don’t know what to do with it.”

More Testing Equals More Knowledge

Further complicating the issue, there is an enormous lack of information on how multipanel screenings will affect individuals, public health, and the cost of healthcare in general. Several studies are underway, but they are so new it could be years before any real results become available.

Five years ago, it cost about $20,000 to sequence the whole human genome. Now the average price is $1,500, though there are more and less expensive types of genetic tests. As the cost continues to decline, however, more people will undergo the testing and scientists will learn more about how to identify the best therapy to treat cancers caused by genetic mutations.

—Dava Stewart

Related Information:

Loxo Oncology Announces Positive Top-Line Results from Independent Review Committee Assessment of Larotrectinib Dataset

National Cancer Institute Statistics

Promising New Cancer Drugs Won’t Go Far Unless Everyone Gets Genetic Testing

Tumor DNA Sequencing in Cancer Treatment

Will Health Insurance Cover the Costs of Genetic Testing?

A Single $249 Test Analyzes 30 Cancer Genes. But Do You Need It?

Personal Genome Test Will Sell at New Low Price of $250

 

Top-5 Diagnostics Trends Identified by Kalorama Will Impact In Vitro Diagnostics Manufacturers, Medical Laboratories in 2017

Apr 3, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations

Report states IVD companies are focusing on core lab, seeking China FDA approval, and targeting urgent care

Several of the same powerful trends reshaping healthcare and clinical laboratory services are having equally significant influence on in vitro diagnostics (IVD) manufacturers. In particular, the consolidation of hospitals and physicians, as well as the emergence of new sites of service—such as urgent care centers and retail clinics—are motivating IVD companies to tailor new diagnostic systems to the unique needs of these entities.

Kalorama, a division of MarketResearch.com, has released its list of Top-Trends that will affect IVD developers in 2017. IVDs are at the heart of the medical laboratory industry. Thus, these reports are critical to keeping clinical laboratory managers and pathology groups informed on anything that could affect the production, voracity, and availability of diagnostic testing. (more…)

Genetic Tests and Precision Medicine Start to Win Acceptance by Some Payers; Pathologists and Clinical Laboratories Have Opportunity as Advisors

Mar 14, 2016 | Digital Pathology, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology

UnitedHealthcare to cover Foundation Medicine’s comprehensive genomic profiling assay for solid tumors, but Medicare still reluctant to reimburse for genetic tests

Studies showing success of targeted therapies in cancer care may be having an influence on the decisions by certain health insurers to reimburse clinical laboratories to reimburse for certain genetic tests.

One example that press reports cite is how last December UnitedHealthcare began reimbursing for a certain genetic test for patients with a particular lung cancer, according to a statement from Foundation Medicine (NASDAQ:FMI). Based in Cambridge, Massachusetts, Foundation Medicine describes itself as “a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer.” (more…)

Google Files Patent for Needle-free Blood Draw System That Could Eventually Remove Clinical Laboratories and Pathology Groups from the Process

Mar 7, 2016 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing

Patent filing describes a device that is intended to allow patients to collect their own blood specimens without the need for needles

Google, (now known as Alphabet, Inc.; NASDAQ:GOOG) recently filed an application for another patent that deals with medical laboratory test technology. This patent application is for a needle-free blood draw system that enables patients to perform diagnostic testing on themselves.

The new system is designed to replace painful finger pricks and deliver diagnostic test results digitally to providers’ electronic health record (EHR) systems. Should the technology make it through clinical trials, widespread adoption of such a device could have sweeping implications for pathologists and clinical laboratories across America. (more…)

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