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Clinical Laboratories and Pathology Groups

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

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Scientists Encode Malware with Synthesized DNA That Targets DNA Analysis Software Commonly Found in Gene Sequencers Used by Clinical Laboratories

Researchers demonstrated it was feasible to encode digital malware onto a strand of synthesized DNA and infect the gene sequencers and computer networks used by medical laboratories

As if anatomic pathology groups and clinical laboratory leaders don’t already have enough to think about, here comes a security vulnerability right out of a sci-fi thriller. Researchers at the University of Washington (UW) have used synthesized DNA to encode digital malware into a physical strand of DNA capable of establishing a remote connection to the computer network on which the sequenced DNA is read!

Stated differently, researchers have now demonstrated that is possible for bad guys to hack into a medical laboratory’s instrument systems and computer network using a physical strand of synthesized DNA that is encoded with digital malware.

Another Threat to Clinical Laboratories, Pathology Groups?

Does this translate into an immediate security issue for medical laboratories? For now, the threat is only theoretical. While researchers did succeed, their study findings should provide some comfort to pathology groups or medical laboratories worried about the implications of DNA-based malware. The UW researchers published their findings at the 2017 USENIX Security Symposium.

Synthetic DNA Malware Exploit is More Proof-of-Concept than Immediate Threat

At its core, computer code (AKA source code) is similar to DNA in that it is composed of a set number of states—with binary, zeroes, and ones. This led UW researchers to question whether they could translate the AGCT elements (adenine, guanine, cytosine, and thymine) of DNA into binary code capable of hacking DNA sequencers and accessing the information they contain.

In an article in The Atlantic, Tadayoshi Kohno, PhD, Short-Dooley Professor in the Department of Computer Science and Engineering at UW, who led the research team, noted that, “The present-day threat is very small, and people don’t need to lose sleep immediately. But we wanted to know what was possible and what the issues are down the line.”

Complexity of Engineering a DNA-Powered Computer Virus

To begin the process, researchers needed to create a specific DNA strand encoded with the exact proteins that would later convert into their exploit. An article in ArsTechnica suggests this would be a challenge due to the physical properties of DNA’s double-helix design.

In the article, John Timmer, PhD, wrote, “DNA with Gs and Cs forms a stronger double-helix. Too many of them, and the strand won’t open up easily for sequencing. Too few, and it’ll pop open when you don’t want it to.”

The study shows it took multiple attempts to find a DNA sequence that would both carry the malware code and withstand the synthesizing and sequencing processes. Even then, researchers needed an exploit for the software used on sequencers in clinical laboratories and other diagnostics providers to prove their theory. Study authors used their own modified version of an open-source sequencing software, adding an exploit they could target, instead of a version of the software already publicly in use.

Lee Organick (above left), Karl Koscher (center), and Peter Ney (right) worked with Luis Ceze and Tadayoshi Kohno, PhD, at the University of Washington to develop the DNA sequence containing the malware code. The researchers determined that it was feasible for the gene instruments used by clinical laboratories to be infected with the malware, which could then move to infect a clinical lab’s computer network. (Photo copyright: University of Washington.)

With their proteins synthesized and customized software in place, researchers still faced challenges getting the code to trigger. “With reads randomly appearing in an FASTQ file,” the researchers noted, “we would expect the modified program to be exploited 37.4% of the time.”

As with genetic code, the binary code of a program is highly sensitive to errors. Any misread bases or splitting of the code resulted in failure. When sequencers only read a few hundred bases at a time, ensuring the code doesn’t hit one of these splits is a challenge.

One unique difference between binary and genetic code also caused trouble—genetic sequences aren’t direction dependent, while binary sequences are. If the code is read in reverse, it won’t execute properly.

Future Concerns for Clinical Laboratories and Genetic Researchers

Today, the threat to medical laboratories and the sensitive data generated by sequencing is minor. However, tomorrow that threat could be more common.

In a WIRED article on the subject, Jason Callahan, Chief Information Security Officer for Illumina stated, “This is interesting research about potential long-term risks. We agree with the premise of the study—that this does not pose an imminent threat and is not a typical cyber security capability.”

Don Rule, founder of Translational Software, agrees. When asked about the threat posed to clinical laboratories, he said, “… if you have to pre-introduce the hack in the analytics program, this is a pretty circuitous way to take over a computer. I can see how it is feasible and right now Norton Antivirus is not looking for viruses encoded in the AGCT code set, but we are right not to lose a lot of sleep over it.”

However, as genetic sequencing becomes a common part of medicine, attackers might have increased reason to disrupt services or intercept data. The UW researchers cite “important domains like forensics, medicine, and agriculture” as potential targets.

While their successful attack was highly engineered, their research into open-source sequencing software revealed a range of common security weaknesses. Many clinical laboratories and anatomic pathology groups also run proprietary analysis software or use hardware with embedded software.

They recommend that medical laboratories work to centralize software updates and create ways to verify data and patches through digital signatures or other secure measures.

Already, genetic researchers take care to avoid synthesizing potentially dangerous sequences, and to contain tests and data. But this study shows that not all threats come from within the research or clinical laboratory environment. Both engineers of sequencing technology and hardware—and the medical laboratories using them—will need to optimize operations and monitor trends closely to see how security issues evolve alongside sequencing capabilities.

—Jon Stone


Related Information:

These Scientists Took Over a Computer by Encoding Malware in DNA

Computer Security and Privacy in DNA Sequencing

Computer Security, Privacy, and DNA Sequencing: Compromising Computers with Synthesized DNA, Privacy Leaks, and More

This Speck of DNA Contains a Movie, a Computer Virus, and an Amazon Gift Card

Researchers Encode Malware in DNA, Compromise DNA Sequencing Software

Biohackers Encoded Malware in a Strand of DNA

The Ultimate Virus: How Malware Encoded in Synthesized DNA Can Compromise a Computer System

Researchers Hacked into DNA and Encoded It with Malware

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

Every medical laboratory ready to begin the move away from fee-for-service payment and towards value-based reimbursement needs to start offering lab tests that support the practice of precision medicine

Nearly every clinical laboratory and pathology group in America today is aware of the opportunity to provide medical laboratory tests that enable physicians to successfully practice precision medicine. The goal of precision medicine is to enable a patient to get a more accurate diagnosis, receive the most appropriate therapy, and have his/her condition monitored with unprecedented insight during the course of treatment.

The good news for the clinical laboratory industry concerning precision medicine is that it is the fastest-growing sector of lab testing and these are the tests that contribute the greatest value in patient care. For example, molecular and genetic tests are revolutionizing the diagnosis and treatment of infectious disease. These are the clinical lab tests that enable a physician to identify the specific subtype of the bacteria or virus, then help him or her select the therapeutic drug that will have maximum benefit for the patient.

Clinical Laboratories Support Cancer Diagnosis with Companion Diagnostic Tests

It is equally true that the diagnosis and treatment of cancer is undergoing a major transformation. Genetic knowledge is being used to develop both diagnostic tests and new therapies that enable physicians to better diagnose cancer, and then treat it with the drugs identified by a companion diagnostic test as having the best potential to cure the patient or slow the progression of the disease.

But if there is an area of precision medicine with immense potential, it is pharmacogenomics and its associated testing.

In 2015, the Kaiser Family Foundation reported that more than four billion prescriptions were filled in the United States. As science understands more about the human genome, proteome, metabolome, and microbiome (to name just a few of the “omes”), it becomes possible to design clinical laboratory tests that:

1. Contribute to a more accurate diagnosis;

2. Identify which prescription drugs will be of the greatest benefit; and

3. Inform the physician as to which drugs will not be effective and may even be harmful to the patient.

More Good News for Medical Laboratories

There is even more good news. Many clinical laboratories, hospital labs, and pathology groups already have lab instruments capable of performing the tests used in precision medicine. For these labs, no major up-front investment is needed to begin offering tests that allow physicians to practice precision medicine.

“Many of our lab clients got started in this way,” stated Don Rule, MBA, Founder and Chief Executive Officer of Translational Software in Bellevue, Wash. “They realized that their existing lab instruments could run some of the lab tests physicians use when practicing precision medicine. This would be a low-cost way to enter the precision medicine field and they could, on a small scale with minimal risk, begin offering these tests to gain experience, learn more about the market, and identify which such tests would have highest value to the physicians in the communities they serve.”

Is Your Pathology Group Interested in Supporting Precision Medicine?

“For a lab that is serious about understanding the current and future clinical demand for precision medicine tests, several careful steps are recommended,” he continued. “One step is to build demand by educating clinicians and their staffs about the best ways to use these tests to improve patient care. Keep in mind that more of a physician’s reimbursement is now keyed to the patient outcomes they deliver. These doctors recognize that labs helping them do a better job with precision medicine are also helping them demonstrate greater value in the patient care they provide.

“There are other steps required to launch an effective, clinically successful precision medicine testing program,” Rule noted. “For example, labs need to understand how to be paid by the health insurers in their region. That includes getting in-network and teaching physicians and lab staff how to follow each payer’s clinical and coding criteria so that clean claims will be paid in a timely manner.

“Another step is to build the market in a careful fashion,” he emphasized. “For example, labs should identify the thought leaders among their clients and work with them to demonstrate the clinical utility of tests performed in support of precision medicine. And above all, it’s important to focus on patients that are most likely to get some insight from testing. When your lab starts with the right population, it’s remarkable how often you will uncover actionable issues.”

Clinical Labs Can Enter Precision Medicine by Initially Referring Tests

“It’s also feasible for a lab to start its precision medicine strategy by referring out testing in the early stages and using third-party experts to do the interpretations,” Rule advised. “Then, as specimen volume increases, and the lab’s clinical team gains more experience with these molecular and genetic tests, it becomes easy to bring that testing in-house to develop the market further with faster turnaround times and in-house expertise that local physicians appreciate.”

Every clinical lab, hospital lab, and pathology group that is considering how to support precision medicine will want to participate in a special webinar, titled, “What Molecular and Genetic Testing Labs Need to Know to Succeed with Commercialization of Their Precision Medicine Products.” It will take place on Wednesday, March 22, 2017 at 1 PM EDT.

Two expert speakers will cover the essentials that all labs should know about building a market presence in precision medicine. First to present is Don Rule of Translational Software. Rule currently provides a variety of services to more than 80 lab clients, which includes the annotation and interpretation of gene sequences. In addition, Rule and his team provide consulting expertise to help labs develop their strategies for precision medicine, identify the best tests to offer physicians, and develop the steps needed to obtain network status with payers.

Webinar Will Present the Best Successes of Molecular, Genetic Testing Labs

Rule will share the experiences and best successes of the molecular and genetic testing labs he has worked with since 2009. He will discuss the types of lab tests used in precision medicine in different specialties, identify the fastest-growing sectors, and note which instruments already found in most clinical laboratories can be used to provide lab tests used for precision medicine.

Don Rule (above left), Founder and CEO of Translational Software, and Kyle Fetter (above right), Vice President of Advanced Diagnostics at XIFIN, will share their unique insights, knowledge, and experience at developing a precision medicine lab testing program for clinical laboratories that want to build more market share, make the billing/collections team more effective, and increase revenue. (Photo copyright: Dark Daily.)

Don Rule (above left), Founder and CEO of Translational Software, and Kyle Fetter (above right), Vice President of Advanced Diagnostics at XIFIN, will share their unique insights, knowledge, and experience at developing a precision medicine lab testing program for clinical laboratories that want to build more market share, make the billing/collections team more effective, and increase revenue. (Photo copyright: Dark Daily.)

As one example, a growing number of long-term care facilities are using tests to practice precision medicine—and paying for these tests under value-based arrangements—because so many of their patients are taking from 10 to 15 prescriptions each day. If a lab test indicates that the patient may not be getting therapeutic benefit from a specific drug (or that there are negative side effects from the polypharmacy), then the long-term care facility is money ahead because of less spending on drugs and the decreased care costs from patients who remain healthier. In the extreme case, the care facility might lose a patient to a skilled nursing facility due to mental fog or a fall that is precipitated by adverse drug effects.

Making the Case for a Precision Medicine Lab Testing Program

Additional topics to be discussed are:

• How to make the case to administration and the clinicians;

• How to build demand; and

• How to identify thought leaders and work with them to educate the physicians in the lab’s service region.

The second speaker will address the important topic of how to get paid. Kyle Fetter, MBA, is Vice President of Advanced Diagnostics at XIFIN, Inc., based in San Diego. XIFIN provides revenue cycle management (RCM) services to more than 200 labs and handles as many as 300 million lab test claims annually. What this means is that Fetter sees which labs are most successful with their coding, billing, and collections for molecular and genetic tests. He also sees how different payers are handling these claims.

During his presentation, Fetter will provide you and your lab team with valuable knowledge about the best ways to collect the information needed to submit clean claims and be paid promptly. He will illustrate ways to optimize the process of gathering this data and the different software tools that not only make the job easier, but help ensure that a higher proportion of claims are clean and paid at first submission.

Secrets of Preparing for Payer Challenges, Denials, and Audits

But the single best element of Fetter’s presentation will be how labs performing molecular and genetic testing should prepare, as part of the normal course of business, for the inevitable challenges, denials, and audits. He will describe the elements of a system that helps labs be ready to make the case that claims are properly documented, and that they represent appropriate and necessary tests for the patient.

You can find details for this important webinar at this link. (Or copy this URL and paste it into your browser:

This webinar is perfect for any lab that is already performing molecular and genetic tests, and which is interested in building more market share, making the billing/collections team more effective, and increasing revenue.

For every lab watching the precision medicine space, this webinar is a “must attend” because it delivers to you and your lab team the collective knowledge and insights from two experts who are working with hundreds of the nation’s most successful labs. It is your guaranteed way to get the accurate, relevant information you need to craft your own lab’s strategy for expanding its molecular and genetic testing opportunities.

—Michael McBride

Related Information:

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

Innovative Clinical Pathology Laboratories Are Adding Value to Pharmacogenomic Test Reports to Help Physicians Better Interpret and Act upon the Results

There’s even a company called Translational Software providing a service to incorporate enriched information about such tests into the reports that labs deliver to doctors

Personalized medicine is the good news story in healthcare and clinical laboratory medicine today. Armed with new understanding about the human genome, physicians are able to customize therapies for patients that will produce the best outcomes while avoiding or minimizing the negative side effects associated with many common prescription drugs.

This is why pharmacogenomics testing is a booming segment of the clinical laboratory industry. On its website, the Duke Center for Personalized and Precision Medicine describes this emerging lab medicine specialty as follows: “Pharmacogenomic tests are used to inform dosing and predict efficacy and adverse events for therapeutic agents. Most tests involve genetic testing, and in the case of cancer, both the DNA of the host and the tumor can be used to inform the choices for treatment.” (more…)