Aug 4, 2017 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
SHERLOCK makes accurate, fast diagnoses for about 61-cents per test with no refrigeration needed; could give medical laboratories a new diagnostic tool
Genetics researchers have been riveted by ongoing discoveries related to Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) for some time now and so have anatomic pathology laboratories. The diagnostic possibilities inherent in CRISPR have been established, and now, a new diagnostic tool that works with CRISPR is set to change clinical laboratory diagnostics in a foundational way.
The tool is called SHERLOCK, which stands for (Specific High-sensitivity Enzymatic Reporter unLOCKing). And it is causing excitement in the scientific community for several reasons:
- It can detect pathogens in extremely small amounts of genetic matter;
- Tests can be performed using urine and/or saliva rather than blood;
- The tests are extremely sensitive; and they
- Cost far less than the diagnostic tests currently in use.
In an article published in Science, researchers described SHERLOCK tests that can distinguish between strains of Zika and Dengue fever, as well as determining the difference between mutations in cell-free tumor DNA.
How SHERLOCK and CRISPR Differ and Why That’s Important
Scientists have long suspected that CRISPR could be used to detect viruses. However, far more attention has been given to the its genome editing capabilities. And, there are significant differences between how CRISPR and SHERLOCK work. According to the Science article, when CRISPR is used to edit genes, a small strip of RNA directs an enzyme capable of cutting DNA to a precise location within a genome. The enzyme that CRISPR uses is called Cas9 (CRISPR associated protein 9). It works like scissors, snipping the strand of DNA, so that it is either damaged or replaced by a healthy, new sequence.
SHERLOCK, however, uses a different enzyme—Cas13a (originally dubbed C2c2 by the researchers who discovered it). Cas13a goes to RNA, rather than DNA, and once it starts cutting, it doesn’t stop. It chops through any RNA it encounters. The researchers who developed SHERLOCK describe these cuts as “collateral cleavage.” According to an article published by STAT, “All that chopping generates a fluorescent signal that can be detected with a $200 device or, sometimes, with the naked eye.”
The screenshot above is from a video in which Feng Zhang, PhD (center), a Core Member of the Broad Institute at MIT and one of the lead researchers working on SHERLOCK, and his research team, explain the difference and value SHERLOCK will make in the detection of diseases like Zika. Click on the image above to watch the video. (Video copyright: Broad Institute/MIT.)
Early Stage Detection in Clinical Laboratories
A research paper published in Science states that SHERLOCK can provide “rapid DNA or RNA detection with attomolar sensitivity and single-base mismatch specificity.” Attomolar equates to about one part per quintillion—a billion-billion. According to the article on the topic also published in Science, “The detection sensitivity of the new CRISPR-Cas13a system for specific genetic material is one million times better than the most commonly used diagnostic technique.” Such sensitivity suggests that clinical laboratories could detect pathogens at earlier stages using SHERLOCK.
The Stat article notes that, along with sensitivity, SHERLOCK has specificity. It can detect a difference of a single nucleotide, such as the difference between the African and Asian strains of Zika (for example, the African strain has been shown to cause microcephaly, whereas the Asian strain does not). Thus, the combination of sensitivity and specificity could mean that SHERLOCK would be more accurate and faster than other diagnostic tests.
Clinicians in Remote Locations Could Diagnose and Treat Illness More Quickly
Perhaps one of the most important aspects of SHERLOCK is the portability and durability of the test. It can be performed on glass fiber paper and works even after the components have been freeze dried. “We showed that this system is very stable, so you can really put it on a piece of paper and it will survive. You don’t have to refrigerate it all the times,” stated Feng Zhang, PhD, in an interview with the Washington Post. Zhang is a Core Member of the Broad Institute at MIT and was one of the scientists who developed CRISPR.
The researchers note that SHERLOCK could cost as little as 61-cents per test to perform. For clinicians working in remote locations with little or no power, such a test could improve their ability to diagnose and treatment illness in the field and possibly save lives.
“If you had something that could be used as a screening test, very inexpensively and rapidly, that would be a huge advance, particularly if it could detect an array of agents,” stated William Schaffner, MD, Professor and Chair of the Department of Preventive Medicine at Vanderbilt University Medical Center, in the Post article. Schaffner describes the Broad Institute’s research as being “very, very provocative.”
The test could radically change the delivery of care in more modern settings, as well. “It looks like one significant step on the pathway [that] is the Holy Grail, which is developing point-of-care, or bedside detection, [that] doesn’t require expensive equipment or even reliable power,” noted Scott Weaver, PhD, in an article on Big Think. Weaver is a Professor and Director at the Institute for Human Infections and Immunity University of Texas Medical Branch in Galveston, Texas.
Just the Beginning
Anatomic pathologists and clinical laboratories will want to follow SHERLOCK’s development. It could be on the path to fundamentally transforming the way disease gets diagnosed in their laboratories and in the field.
According to the Post article, “The scientists have filed several US patent applications on SHERLOCK, including for uses in detecting viruses, bacteria, and cancer-causing mutations.” In addition to taking steps to secure patents on the technology, the researchers are exploring ways to commercialize their work, as well as discussing the possibility of launching a startup. However, before this technology can be used in medical laboratory testing, SHERLOCK will have to undergo the regulatory processes with various agencies, including applying for FDA approval.
—Dava Stewart
Related Information:
New CRISPR Tool Can Detect Tiny Amounts of Viruses
CRISPR Cousin SHERLOCK May Be Able to Track Down Diseases, Scientists Say
Nucleic Acid Detection with CRISPR-Cas13a/C2c2
A New CRISPR Breakthrough Could Lead to Simpler, Cheaper Disease Diagnosis
Meet CRISPR’s Younger Brother, SHERLOCK
Trends in Genomic Research That Could Impact Clinical Laboratories and Anatomic Pathology Groups Very Soon
Pathologists and Clinical Laboratories May Soon Have a Test for Identifying Cardiac Patients at Risk from Specific Heart Drugs by Studying the Patients’ Own Heart Cells
Patent Dispute over CRISPR Gene-Editing Technology May Determine Who Will Be Paid Licensing Royalties by Medical Laboratories
Aug 2, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Agreements to open PSCs in the nation’s largest retail grocery and pharmacy chain stores shows a willingness by clinical laboratories to attract customers through convenience
Greater use of retail stores as the location for patient services centers (PSCs) may be an important new trend for the clinical laboratory industry. That’s because, historically, medical laboratories placed most of their patient service centers in hospital campuses or near medical office buildings.
However, in recent months, both of the nation’s billion-dollar lab companies signed deals with national retailers to put patient service centers in their stores. Dark Daily believes that the motivation for a lab company to put a PSC into a grocery store or retail pharmacy is to make it easier and more convenient for a patient to get their specimen collected at a location that is closer to their home or office. In other words, it is faster for the patient to get to their nearest grocery store for a blood draw than to travel to the hospital campus in their community.
Various news reports indicate that Quest Diagnostics (Quest) may be more active than Laboratory Corporation of America (LabCorp) in opening PSCs in grocery stores and retail pharmacies. Over the last four months, Quest has announced plans to open patient services centers with several retailers, particularly in the states of Texas and Florida. Similarly, in the past four weeks, LabCorp disclosed an agreement with Walgreens Boots Alliance (Walgreens).
Ground zero for this current interest in putting PSCs into retail stories is Phoenix, Arizona. In 2014, to serve its direct-to-consumer lab testing business model, Theranos had PSCs in about 40 Walgreen’s pharmacies. Pathologists and clinical laboratories will recall that in November, 2015, Sonora Quest Laboratories of Phoenix opened a patient service center (PSC) in a Scottsdale, Ariz., supermarket owned by Safeway. It was the first PSC Sonora Quest had opened in collaboration with a grocery store chain, but it was not the last. Less than a year later, Sonora Quest and Safeway expanded their operations by opening additional PSCs in stores throughout the Grand Canyon State.
At the same time Sonora Quest was stepping into the retail blood-drawing business, Theranos of Palo Alto, Calif., was exiting it after opening 40 PSCs in Walgreens pharmacies, most of them in Arizona. However, before leaving the lab-testing business altogether, the embattled company put a lot of effort into educating consumers about the benefits of purchasing lab tests without a physician’s order. Theranos had even supported a bill (HB2645) the Arizona State Legislature passed that allowed patients to order tests without a physician’s requisition.
Now, in 2017, Quest Diagnostics (NYSE:DGX) appears interested in following a similar strategy as Theranos and Sonora Quest by developing Quest-branded PSCs in retail chain stores. On its website, Quest states that in the past several years it has opened 106 PSCs in Albertsons, Randalls, Safeway, Tom Thumb, and Vons retail stores in nine states.
Quest Moves to Open PSCs Across America
Quest has PSCs in the following states:
- California (12 stores);
- Colorado (27);
- Delaware (1);
- Maryland (9);
- Montana (4);
- Oregon (10);
- Texas (26);
- Virginia (7); and
- Washington State (10).
This Quest patient service center operates within a Safeway store location. (Photo copyright: Quest Diagnostics.)
In June 2017, Quest announced it would open 10 additional PSCs in Tom Thumb retail stores in North Texas by the end of the month. Thom Thumb is a division of Albertsons, a food and drug retailer with stores nationwide. In the same announcement, Quest said it plans to open PSCs in 200 Albertson’s-owned stores nationwide by the end of the year.
Give Blood Then Shop
Also in June, Quest and Walmart (NYSE:WMT) announced a deal in which the two companies would open co-branded PSCs in 15 Walmart stores in Florida and Texas by the end of 2017.
In these locations, Quest encourages patients to have their blood drawn and then shop. Such locations can accommodate collecting specimens for routine blood work, such as total cholesterol and white blood cell count, as well as complex gene-based and molecular testing. Even patients with such chronic conditions as cancer, diabetes, and hepatitis, are encouraged to use these PSCs, the lab-testing company stated in the announcement.
Not to be outdone, LabCorp also announced a deal with Walgreens in June. In Forbes, Bruce Japsen reported that Walgreens (NASDAQ:WBA) announced it would collaborate with LabCorp (NYSE:LH) to develop and operate PSCs in Walgreens drugstores in Colorado, Illinois, and North Carolina.
The deal is the first for Walgreens since its troubled relationship with Theranos ended last year. Walgreens’ collaboration with LabCorp will initially begin this summer with five patient service centers in Denver and one in Morrisville, N.C. A seventh location in Deerfield, Ill., will open by the end of the year. Financial terms of the partnership were not disclosed.
Lessons Clinical Laboratories Learned with PSCs in Retail Stores
For Quest, the speed with which it is opening new PSCs is significant, because it seems to have taken lessons that Theranos and Sonora Quest learned earlier in Ariz. and applied them to markets nationwide. It’s worth noting that Safeway and Albertsons were already two of the largest retail grocery chains in the nation before they merged in 2015.
So, while Sonora Quest was working with Safeway, its parent company, Quest, was working with Albertsons.
One other point that is significant about Quest’s efforts is that not many other clinical laboratories have a presence in retail stores. It’s unknown just how much specimen volume these retail operations generate for Quest, one of the largest clinical lab companies in America. And, it is unknown if these PSCs in retail settings are breaking even or making a profit.
One result, however, is clear. That Quest is being so aggressive in opening PSCs testifies to the company’s level of interest in serving consumers directly. In other words, these PSCs are not primarily a direct-to-consumer play, but are aimed at building market share by adding regular lab testing done for patients. In this way, the direct-to-consumer business that Quest generates is a bonus.
The deals by Quest and LabCorp also imply that both clinical laboratory companies are willing to bet on the fact that consumers may prefer the convenience of using PSCs located in retail stores they currently frequent, rather than going to patient service centers in hospitals and sitting in a waiting rooms.
—Joseph Burns
Related Information:
Quest Diagnostics and Walmart Team Up to Expand Access to Healthcare Services
Walgreens Partners with LabCorp in New Diagnostic Testing Deal
Walgreens to Roll Out Urine, Blood Testing at Some Stores
Walgreens Partners with LabCorp on In-Store Lab Testing Services
Walmart and Quest Team Up for Lab Services
Quest’s Lab Services in New, Convenient Locations
You Can Now Get Lab Tests Done at Safeway Stores – from Theranos’ Rival
Jul 31, 2017 | Laboratory Hiring & Human Resources, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Sales and Marketing, Laboratory Testing, Management & Operations
Sonora Quest Labs and Incyte Diagnostics streamline operations, eliminate data silos, and increase efficiencies using real-time analytics from laboratory-specific CRM
Across the nation, clinical laboratories and anatomic pathologists face two common challenges. One is shrinking lab budgets and less payment for lab tests. The other is the need to maintain physician and patient services at a high level. Both factors are fueling greater interest in lab and healthcare-specific customer relationship management (CRM).
Stated another way, labs and pathology groups are being squeezed by the need to operate on less revenue, while also increasing their quality of customer service to retain existing clients and expand market share. CRMs are a proven way to achieve and sustain superior levels of customer service in a surprisingly cost-effective way. In fact, many labs that implement a CRM find that the return on investment comes swiftly, in just a few months.
Clinical Laboratories and Pathology Groups Hit by Declining Prices, Revenues
“The clinical lab industry is solidly in an era where payers are slashing the prices they pay for lab tests and hospitals—struggling with their own financial problems—are cutting their lab budgets,” observed Robert L. Michel, Editor-in-Chief of The Dark Report, “These factors are motivating lab administrators and pathologists to look for solutions that allow them to run their lab at less cost, while improving staff productivity and customer service.
“This is why first-mover and early-adopter medical labs saw the potential of real-time analytical middleware and lab-specific CRM solutions to help them meet the challenge of running their labs on less money, while simultaneously sustaining superior levels of customer service,” continued Michel. “Every lab manager knows that the path to improved profitability is blocked by poor workflows, time-consuming quality metrics processes, and disconnected sales and customer service teams.”
Innovative medical laboratory managers report that their investment in laboratory-specific CRM systems (also known as healthcare-specific CRM) suddenly gives them access to data that has been locked away within their legacy LIS and other software systems. By unlocking this data in real-time dashboards and reports, they gain competitive advantage in the lab testing marketplace. A healthcare-specific CRM makes it possible to monitor a wide range of activities, including:
- Proactively tracking relations with client physicians;
- Monitoring workflow and lab operations in real time; and
- Gaining a comprehensive view of all sales and customer service activities at both the aggregate and provider levels.
Tracking Key Benchmarks, Productivity, and Accountability
Sonora Quest Laboratories (SQL) of Tempe, Ariz., a joint venture between Banner Health and Quest Diagnostics (NASDAQ:DGX), wanted to reduce the amount of time spent collating reports and performing manual calculations, as well as breaking down cumbersome data silos across the organization in order to streamline communication and collaboration.
Prior to activating a laboratory-specific CRM platform, employees at SQL spent five hours per day pulling key metrics and reports. To move forward with strategic initiatives, the company could not continue to “struggle with endless silos of data and information,” a case study on SQL’s challenges states.
CRM Designed for Medical Laboratories and Pathology Groups
To address these concerns, SQL turned to a laboratory-specific CRM that integrates existing silos and systems into a centralized interface through automated data capturing. The solution provides detailed, real-time dashboards with visibility across the organization. Graphs and charts enable users to:
- Track their progress meeting turnaround time benchmarks;
- Ensure their volume is level-loaded; and
- Track by the hour how many tests are coming in and completed, the case study notes.
The hc1 customer-relationship management (CRM) dashboard (above) provides an easy-to-navigate interface for tracking multiple benchmarks and key workflows for clinical laboratories and healthcare providers. (Image copyright: hc1.)
“The first step was to integrate our LIS [laboratory information system], and our timekeeping, call center metrics, and bench scheduling tools, into the hc1 CRM solution we had installed,” stated Tamara Nelson, Lean Master Black Belt at SQL. “Once that was accomplished, we could build actionable reports to determine where to focus our process improvement efforts.
“Now we can look at high-level trends in lab productivity,” noted Nelson. “We can also drill down to look at every process in our lab by hour, shift, discipline, instrument, and employee to compare time periods and other factors.”
According to the case study about Sonora Quest Laboratories, after its activation of the healthcare CRM, SQL reduced time spent pulling daily performance reports from about five hours per day to just 45 minutes a day. This increased overall employee efficiency by 85%.
SQL’s use of the CRM now makes it possible to:
- Provide real-time financial and operation trend analysis to key stakeholders;
- Use live dashboard and reports to review and manage TAT (turn-around time) benchmarks, utilization, reimbursements, volume, and productivity;
- Track employee productivity across departments to drive accountability; and
- Broadcast reports to immediately notify key stakeholders of any risks, missed benchmarks, or red flags.
Better Way for Clinical Laboratories to Track Client Interactions
Another medical laboratory that benefitted from implementing a laboratory-specific CRM is Incyte Diagnostics of Spokane Valley, Washington. Founded in 1957 by pathologists, Incyte provides anatomic pathology services throughout the Pacific Northwest.
Incyte needed a way to consolidate data coming from the multiple systems used to manage its sales process and payer information. The different systems created a disconnect between departments and, as structured, could only deliver a few real-time insights into volume or revenue shifts, client account activity, marketing campaigns, or sales activities.
Having received 35,000 e-mails from his sales team during the previous two years, Incyte’s Chief Marketing Officer Nate Koenig knew he had to find a better way to track client interactions.
“We needed a better understanding of what was taking place within our clients’ hospitals. To grow, we had to improve. That’s where the CRM solution we selected proved invaluable,” stated Koenig in a case study detailing how Incyte found a solution to tedious workflows and disorganized information tracking.
After adopting a healthcare CRM, Incyte could:
- Help sales reps gain more field time;
- Centralize client information;
- Track sales activities;
- Properly store data; and
- Gain access to real-time analytics.
Anatomic Pathology Lab Exceeded Production Goals and Customer Expectations
According to the case study, by eliminating data silos and streamlining sales operations Incyte was able to:
- Exceed its sales growth goal in 2016 by 107%;
- Retain 99.51% of current business;
- Reduce the overall workload of the client services team 6.25%; and
- Gain 32 additional days of field time for its 17 sales reps.
Both Sonora Quest Laboratories and Incyte, Inc., are examples of how innovative medical laboratories are using informatics to meet the challenges of declining revenue and the need to sustain a high level of customer service. In today’s connected world, those labs that are first to achieve useful integration of their LIS with a CRM will enjoy competitive advantage.
Surviving in this challenging environment means clinical laboratories and anatomic pathology groups must unlock the power of data informatics to improve their financial performance and better serve providers and patients. To help laboratory leaders reach these goals, The Dark Report recently published a white paper titled, “3 Critical Rules for Surviving in 2017: Your Medical Laboratory’s Guide to Thriving in Today’s Healthcare Landscape.”
This essential resource demonstrates how a laboratory-specific CRM enables medical laboratories to not just survive, but to thrive in today’s healthcare environment, while providing added value to healthcare consumers and providers.
Get your copy of this important asset by clicking on this link. Or, copy this URL into your browser: https://ddaily.wpengine.com/whitepaper/3-critical-rules-for-surviving-in-2017-your-medical-laboratorys-guide-to-thriving-in-todays-healthcare-landscape.
—Andrea Downing Peck
Related Information:
3 Critical Rules for Surviving in 2017: Your Medical Laboratory’s Guide to Surviving in Today’s Healthcare Landscape
How Incyte Dx Eliminated Data Silos and Streamlined Operations to Exceed Sales Growth Targets by 107%
How Sonora Quest Labs Eliminated 4 Hours a Day in Performance Report Work
Clinical Laboratories Turn to Healthcare-Focused CRM to Optimize Operations and Increase Market Share, Despite Decreasing Reimbursement
More Clinical Pathology Laboratories Use Middleware for Business Intelligence and Lab-specific Customer Relationship Management
Jul 28, 2017 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Project should provide treasure-trove of molecular information on human protein and lead to development of new biomarkers for use in clinical laboratory tests and personalized medicine
Human proteins provide clinical laboratories and anatomic pathology groups with a rich source of biomarkers used in medical tests and personalized medicine. Pathologists, therefore, should take note of a major milestone achieved by researchers from the Technical University of Munich (TUM) that moves science closer to developing a way to understand the complete human proteome.
Scientists participating in the ProteomeTools project have announced the synthesis of a library of more than 330,000 peptides representing essentially all canonical proteins of the human proteome.
Translating Human Proteome into Molecular and Digital Tools
The ProteomeTools project is “a joint effort of TUM, JPT Peptide Technologies, SAP SE, and Thermo Fisher Scientific … dedicated to translating the human proteome into molecular and digital tools for drug discovery, personalized medicine, and life science research.” Over the course of the project, 1.4 million synthetic peptides covering essentially all human gene products will be synthesized and analyzed using multimodal liquid chromatography-tandem mass spectrometry (LC-MS/MS).
ProteomeTools published their first paper, “Building ProteomeTools Based on a Complete Synthetic Human Proteome,” which detailed their work in Nature Methods.
“ProteomeTools was started as a collaborative effort bringing together academic and industrial partners to make important contributions to the field of proteomics. It is gratifying to see that this work is now producing a wealth of significant results,” stated TUM researcher Bernhard Kuster, PhD, one of the leaders of the effort and senior author on the Nature Methods paper, in a TUM news release.
Thousands of New Biomarkers for Clinical Laboratories, and More!
Kuster discussed the significance of the consortium’s work in an article published in Genome Web, which described ProteomeTools as “a resource that provides the proteomics community with a set of established standards against which it can compare experimental data.”
“In proteomics today, we are doing everything by inference,” Kuster stated to Genome Web. “We have a tandem mass spectrum and we use a computer algorithm to match it to a peptide sequence that [is generated] in silico to simulate what their spectrum might look like without us actually knowing what it looks like. That is a very fundamental problem.”
Bernhard Kuster, PhD (above center), of the Technical University of Munich (TUM), led a team of researchers from the ProteomeTools project who completed a tandem mass spectrometry analysis of more than 330,000 synthetic tryptic peptides representing essentially all of the canonical human gene products. The resource eventually will cover all one million peptides. (Photo copyright: Andreas Heddergott/TUM.)
In the Genome Web article, Kuster provides an example of how researchers could use the information developed by ProteomeTools, noting it could be useful for confirming peptide identification in borderline cases. “Because the spectra for these synthetic peptides are available to everyone, you could look up a protein or peptide ID that you find exciting, but where the [experimental] data might not totally convince you as to whether it is true or not,” he explained.
Kuster also states that he believes the resource has the potential to allow “the field to move away from conventional database searching methods toward a spectral matching approach.”
The TUM news release notes that the ProteomeTools project “will generate a further one million peptides and corresponding spectra with a focus on splice variants, cancer mutations, and post-translational modifications, such as phosphorylation, acetylation, and ubiquitinylation.” The end result could be a treasure-trove of molecular information on the human proteome and development of thousands of new biomarkers for clinical use for therapeutic drugs, and more.
“Representing the human proteome by tandem mass spectra of synthetic peptides alleviates some of the current issues with protein identification and quantification. The libraries of peptides and spectra now allow us to develop new and improve upon existing hardware, software, workflows, and reagents for proteomics. Making all the data available to the public provides a wonderful opportunity to exploit this resource beyond what a single laboratory can do. We are now reaching out to the community to suggest interesting sets of peptides to make and measure as well as to create LC-MS/MS data on platforms not available to the ProteomeTools consortium,” Kuster stated in the TUM news release.
All data from the ProteomeTools project is available at the ProteomeXchange Consortium. Pathologists and clinical laboratory professionals working to develop new assays will find it to be a valuable resource.
—Andrea Downing Peck
Related Information:
Researchers Build Complete Synthetic Human Proteome
Building Proteome Tools Based on a Complete Synthetic Human Proteome
Milestone for the Analysis of Human Proteomes
Jul 21, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Pathologists should note that this agreement is not without controversy as the question over who owns patients’ DNA information sparks warnings from legal experts
Did you ever wonder which lab does all the genetic testing for Ancestry as it offers to help consumers learn more about their family histories? Also, were you ever curious about the actual number of genetic tests that Ancestry has generated? After all, its advertisements for these genetic tests are ubiquitous.
You won’t have to wonder any longer, because Dark Daily has the answers. To the first question, it is Quest Diagnostics, Incorporated (NYSE:DGX)—one of the world’s largest clinical laboratory companies—that does the genetic sequencing on the consumer samples provided to it by Ancestry.
To the second question, the number of individual samples in the Ancestry repository and database is now four million, according to information on its website.
AncestryDNA (Ancestry) and Quest Diagnostics (Quest) now collaborate to help consumers learn about their family histories and unlock secrets in their DNA. Since August of 2016, Quest has performed the genomic testing for home DNA kits ordered through Ancestrydna.com. What impact might this have on medical laboratories that perform DNA testing for health and medical reasons?
DNA Testing Reveals Who We Truly Are
“We are very excited to be partnering with Quest Diagnostics to offer our consumer DNA test to more consumers around the world,” stated Tim Sullivan, President and CEO at Ancestry in a news release that announced the genetic testing agreement between the two companies.
To utilize the AncestryDNA service, consumers must first order a DNA kit online through the Ancestry website. The cost of the kit is $99. This includes instructions, a saliva collection tube, and a pre-paid return mailer.
DNA collection kits like the one shown above let people at home do much of the work normally performed in clinical laboratory settings. Though it’s inexpensive compared to standard DNA testing, there is controversy over privacy and ownership of the DNA information. (Photo copyright: BBC/Getty Images.)
After collecting a saliva sample, the customer sends it in for processing. Once the test is completed, an e-mail notification informs the patient that the results can be viewed on AncestryDNA’s website. Typically, a test is completed within six to eight weeks.
The DNA test uses microarray-based autosomal DNA testing, analyzing as many as 700,000 changes in an individual’s genome. These changes (or variations) are called single-nucleotide polymorphisms, or SNPs for short. They are useful in identifying a person’s true ethnicity and can distinguish possible relatives from among people who have previously taken the AncestryDNA test.
“Our focus is on helping consumers around the world take advantage of the latest technology and science to help them learn more about themselves, their families, and their place in the world,” stated Sullivan in another news release.
Managing One’s Health with DNA Information
As noted earlier, AncestryDNA has collected more than four-million DNA samples. Remarkably, its genetic testing service is currently available in more than 30 countries around the globe, according to Ancestry’s website.
The two companies hope to expand their relationship to include the development of applications to explore valuable medical and health information for consumers.
“People are very interested in their family history, and knowing one’s family health history is very important in helping us manage our health,” noted Stephen Rusckowski, Chairman, President and Chief Executive Officer of Quest Diagnostics.
The actual genetic testing is being performed at Quest Diagnostics’ 200,000 square foot facility located in Marlborough, Mass. Quest Diagnostics was chosen for the collaboration after Ancestry requested proposals from several laboratory organizations.
“Adding a second diagnostic partner is a critical step forward as we work to continue to meet the consumer demand we’re seeing for our DNA tests in the US and markets around the world,” stated Ken Chahine, PhD, JD, Executive Vice President at Ancestry and professor at University of Utah S. J. Quinney College of Law in Salt Lake City, in a press release. “We’ll also now be able to move toward an East-West logistical approach, testing kits closer to where our consumers live and, ideally, reducing the time they need to wait to receive their results.”
Concerns Over Patient Privacy and DNA Ownership
Ancestry’s genetic testing program is not without its critics. There are concerns regarding privacy issues and DNA ownership for consumers who use AncestryDNA. Joel Winston, Esq. is a New York attorney who specializes in consumer protection law and commercial litigation. In an article, Winston claimed that Ancestry’s privacy policy and terms of service gave the company complete ownership and control of submitted DNA.
“There are three significant provisions in the AncestryDNA Privacy Policy and Terms of Service to consider on behalf of yourself and your genetic relatives: (1) the perpetual, royalty-free, world-wide license to use your DNA; (2) the warning that DNA information may be used against “you or a genetic relative”; (3) your waiver of legal rights,” Winston wrote.
He claims that Ancestry customers are relinquishing their genetic privacy when they agree to the terms online. Winston urged consumers to fully read, consider, and understand the terms before agreeing to them.
Ancestry responded to the claims by releasing updated terms and conditions for clarity regarding ownership of DNA and information sharing. The company maintains they do not claim ownership rights to DNA submitted to them for testing, and that they do not share DNA testing results with other entities and organizations without customer permission.
In an interview with BBC Radio 4, a spokesperson for Ancestry stated, “We do not share user data for research unless the user has voluntarily opted-in to that sharing.” Adding, “We always de-identify data before it’s shared with researchers, meaning the data is stripped of any information that could tie it back to its owner.”
Nevertheless, Ancestry also stated they would be removing the “perpetuity clause” in AncestryDNA’s online terms and agreements.
The controversy continues and has sparked much debate and reportage from outlets that follow trends in DNA testing and medical laboratories. One such report by the debunking site Snopes attempts to clarify the issues.
Regardless of the debate over ownership of a person’s DNA, this collaboration between Ancestry and Quest Diagnostics is an example of a company relying on diagnostic industry vendors and clinical laboratories to perform services for its customers. It illustrates the need for clinicians and laboratory professionals to remain current on industry trends in ways that might help their labs to increase profits and provide value-added services to consumers. Ancestry’s growing volume of consumer testing demonstrates that there is a potential market for medical laboratories that make themselves available to consumers to answer questions and concerns about DNA testing.
—JP Schlingman
Related Information:
Quest Diagnostics and AncestryDNA Collaborate to Expand Consumer DNA Testing
Ancestry Sets Ancestry DNA Sales Record Over Holiday Period and Fourth Quarter
Clustering of 770,000 Genomes Reveals Post-Colonial Population Structure of North America
Ancestry.com DNA Database Tops 3M, Sales Rise to $850M Ahead of Likely 2017 IPO
Ancestry.com Takes DNA Ownership Rights from Customers and Their Relatives
Setting the Record Straight: Ancestry and Your DNA
Can Ancestry.com Take Ownership of Your DNA Data?
Ancestry.com Denies Exploiting Users’ DNA
Coverage of Alexion Investigation Highlights the Risk to Clinical Laboratories That Sell Blinded Medical Data
Jul 12, 2017 | Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
High-tech hospitals of the future will ‘bring the healing to the patients’ with virtual consultations and remote diagnostic/monitoring services delivering added value to patient care
Hospitals of the future may look nothing like the hospitals of today and those changes could have major implications for clinical pathologists and medical laboratory scientists.
That’s according to Samuel Smits of Gupta Strategists, a consulting firm in the Netherlands that focuses on the four pillars of the healthcare value chain: suppliers, payers, providers, and government institutions.
In an article in The Economist, Smits predicted that traditional hospitals soon will be no more. “We have reached the peak of bringing patients to the healing centers—our hospitals,” he said. “We are on the brink of bringing the healing to patients.”
The article further notes that the technological revolution on the horizon “means abandoning long-held assumptions about the delivery of care, the role of the patient, and what makes a good doctor.” Virtual consultations and remote monitoring will mean fewer patients will need in-hospital care, while those who do will find a facility that operates “more like a cross between a modern airport and a swish hotel, with mobile check-in, self-service kiosks for blood and urine tests and the like, and updates on patients’ and relatives’ phones,” the Economist article states.
Changing How Care is Delivered
The Economist predicts that “as some sophisticated diagnostics, including blood tests and virtual imaging, become available remotely, more patients will receive hospital-quality care without leaving home.”
Patrick Murray, PhD, Senior Director of Worldwide Scientific Affairs for Becton Dickinson Diagnostics in Franklin, NJ, stated in a Clinical Lab Products (CLP) article that technological advances in laboratory testing and diagnosis will enable pathologists to find increasing numbers of ways to deliver added-value to patient care.
“In my opinion, all diseases and conditions—particularly in the areas of overall wellness, women’s health, chronic diseases, and infectious disease—will benefit from the development of new tests and technologies,” Murray stated in the CLP article. “Additionally, new technologies can help meet the need to ensure traceability and seamless communication of test results not only within the lab, but also with the pharmacy, retail clinics, and physician offices, ultimately aiding in better patient management and providing more accurate insights in public health.”
Patient-and-Digital-First Hospitals
While experts predict patient-and-digital-first philosophies to be the future of hospital design, some healthcare systems already have embraced the trend. At Humber River Hospital in Toronto the future is now. An article in Modern Healthcare describes the patient-centered, high-tech, 656-bed facility, which opened in October 2015, as North America’s “first fully digital hospital.” The hospital leverages technology “wherever possible to improve quality, safety, efficiency, and customer service,” the hospital’s website states.
Humber River Hospital (above) in Toronto has been described as North America’s “first digital hospital.” It offers virtual check-in and registration as well as integrated bedside patient computer terminals that enable patients to order meals, adjust lights, play games, and access internet, television, radio, and their patient portal. (Photo copyright: Humber River Hospital.)
Humber River Hospital’s high-tech features include:
- Robotic blood and specimen testing with results available in minutes and sent electronically to the care team with alerts for immediate attention;
- Computerized patient documentation for immediate bedside charting;
- Bedside computers that enable patients to control lights, use telephone and internet, order food, and review their medical, virtual check-in, and registration information;
- A 4,500-square-foot “Command Center” (opens late 2017) will provide real-time data and predictive analytics to improve clinical, operational, and patient outcomes.
Additionally:
- Three-fourths of the hospital’s supply chain is fully automated; and
- Real-time locating systems (RTLS) track wandering patients and improve security for newborns.
Quality, Safety, Efficiency, Customer Service
Despite all the predicted upheaval to the status quo, John Deverill, Managing Partner at GE Healthcare Partners, expects the modern hospital will survive in some form. “There will always be hospitals where patients with complex needs go for multidisciplinary diagnosis and treatment by teams of specialists,” he stated in the Economist article. He does note, however, that stand-alone facilities for specific surgical interventions, such as joint replacements, may become the norm.
However, former Humber River Hospital President and CEO Rueben Devlin, MD, recommends hospitals not assume every high-tech healthcare innovation is worth pursuing.
“The four things that I think about are quality, safety, efficiency, and customer experience,” he stated in the Modern Healthcare article. “People talk about the Internet of things. I think about the Internet of junk. They’re nice toys but they need to show value to healthcare to make it purposeful.”
Anatomic pathology laboratories have a track record for adopting new technologies. Pathologists were early users of the remote telemedicine models, where telepathology systems enabled a pathologist to remotely control the stage and microscope of the pathologist who originated the telepathology session.
Similarly, the current generation of whole-slide imaging and digital pathology systems are gaining regulatory clearance in both Europe and the United States. If this next wave of technological innovations produces a shift in how clinical care is delivered, an opportunity will be created for clinical pathologists and medical laboratory scientists to adopt technologies that deliver added value to patients, including making inpatient hospital stays less likely.
—Andrea Downing Peck
Related Information:
How Hospitals Could Be Rebuilt Better Than Before
The Hospital of the Future Is Here…But it Needs more Gadgets and Bandwidth
Clinical Lab Trends 2016
NASA-like Command Centers are Coming to Hospitals
Will Growth in Number of Tele-ICU Programs in the Nation’s Hospitals Create an Opportunity for Clinical Pathologists to Deliver Added Value?
