Aug 21, 2017 | Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
However, the distinction between how the two different types of diagnostic tests are intended to be used still confuses many physicians and healthcare professionals
Companion diagnostics are well-known to medical laboratorians. However, the new-breed of complementary diagnostics might not be as familiar. As the pharmaceutical pipeline increasingly becomes filled with test-dependent new drug therapies, medical laboratories and anatomic pathology groups may need to sharpen their understanding of companion and complementary diagnostics to broaden their laboratory test portfolios and keep pace with the growing demand for these new diagnostics.
Companion Diagnostics
Currently in the US, 30 companion diagnostic assays have been approved governing the use of 19 therapeutic drugs, according to a recent NCBI table published in Clinical and Translational Science.
The FDA defines a companion diagnostic as a “medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The test helps a healthcare professional determine whether a particular therapeutic product’s benefits to patients will outweigh any potential serious side effects or risks.”
Because a companion diagnostic device is “essential for the safe and effective use” of the drug to which it has been assigned, it is identified on the drug’s product label.
The anti-HER2 drug Herceptin, for example, is a commonly prescribed breast-cancer therapy drug that in its various forms comes with one of 11 companion diagnostic devices. As a requirement of Herceptin’s Food and Drug Administration (FDA) approval, the agency requires pathologists to use a companion diagnostic test to confirm a patient’s over expression of HER2 (human epidermal growth factor receptor2) protein before prescribing Herceptin. The other HER2-directed therapies have their own assigned companion diagnostic.
Complementary Diagnostics Is a Growing Opportunity for Clinical Labs
Now, nearly two decades after companion diagnostics first made headlines, pathologists are encountering a new concept—complementary diagnostics. Unlike companion diagnostics, complementary diagnostics aid the therapeutic decision process, but are not required when prescribing the corresponding drug.
In an interview with Dark Daily, Debra Harrsch, President and Chief Executive Officer of Philadelphia-based Brandwidth Solutions, noted that the addition of complementary diagnostics adds a layer of complexity to the diagnostics landscape for pathologists and other healthcare professionals.
“The diagnostics landscape is not only expanding in size and scope, it is also becoming increasingly complex as growth in biomarker– and genomic-based test strategies fuels progress in personalized medicine,” she stated.
Peggy Robinson (left), US Vice President of ANGLE plc, and, Debra Harrsch (right), President and CEO of Brandwidth Solutions in Philadelphia, spoke with Dark Daily on the differences and values of companion versus complementary diagnostics. “The role that companion diagnostics can have in driving personalized medicine is already leaving its mark with drugs such as Herceptin. The impact of complementary diagnostics and how the two types of tests come to share the stage awaits to be seen,” they noted. (Photo copyright: Dark Daily.)
Peggy Robinson, US Vice President of ANGLE plc, a global liquid biopsy diagnostic company, explained that the lack of a regulatory link to a specific testing technology is the critical distinction between a complementary and a companion diagnostic.
“A companion diagnostic is one of the gateways for you to receive a drug,” Robinson stated in the Dark Daily interview. “A complementary diagnostic can aid your physician in helping to determine what level of therapy would be appropriate for you, but it is not required.”
Pairing Clinical Laboratory Tests with Complementary Diagnostics
In 2015, Dako’s PD-L1 IHC 28-8 pharmDX immunohistochemistry test, which determines PD-L1 protein in non-squamous non-small cell lung cancer, became the first FDA-approved complementary diagnostic, when it was paired with the drug Opdivo (Nivolumab).
At that time, Christopher Fikry, MD, then Vice President, Oncology, of Quest Diagnostics (NYSE:DGX), praised the FDA’s introduction of the first complementary diagnostic. He noted in a statement that it would “give physicians greater understanding of treatment expectations with Opdivo and helpful information to communicate to patients.”
Clinical Laboratories Can Add Value to Their Patients’ Healthcare
The challenge for clinical laboratories and pathology groups will be keeping pace with a rapidly expanding catalog of available diagnostic tests. While the number of drugs (two) with FDA-approved complementary diagnostic tests remains small, Peter Keeling, CEO of Diaceutics, a global advisory group for the laboratory, diagnostic, and pharmaceutical industries, predicts that number will be rising.
In a 2016 webinar on companion versus complementary diagnostics, Keeling pointed out that 50% to 90% of products in development through 2020 at the top 10 pharmaceutical companies are test dependent. This highlights the importance of targeted therapies designed to advance the goals of personalized medicine.
Clinical Labs Can Build Out Test Menus with Complementary Diagnostics
“Laboratorians need to understand what type of technologies they are using to employ these diagnostics,” Robinson told Dark Daily. “As laboratory managers build out their test portfolios, they should be looking at the technology and asking, ‘Can I integrate that into my laboratory?’ so that when a new test comes out, they can offer it.”
Meanwhile, healthcare professionals have more work to do to understand the differences between companion versus complementary test labeling. In his webinar, Kelly noted that in a poll of 30 Opdivo/Keytruda prescribers, Diaceutics found:
- 40% of prescribers surveyed did not understand the differences between the PD-L1 test labels for Keytruda (Pembrolizumab), which requires a companion diagnostic, and Opdivo, which has an associated complementary diagnostic;
- 60% were unclear about the role of complementary testing; and
- 50% said their therapy decisions would be impacted if a laboratory used for PD-L1 testing offered only one test.
Harrsch told Dark Daily that “time will tell” whether complementary diagnostics can match the impact of companion diagnostics in improving healthcare outcomes.
Future of Complementary Diagnostics Still Uncertain
“The role companion diagnostics can have in driving personalized medicine is already leaving its mark with drugs such as Herceptin,” she said. “The impact of complementary diagnostics, and how the two types of tests come to share the stage, awaits to be seen.”
As the market for companion and complementary diagnostics expands beyond targeted therapies for oncology, clinical laboratories and pathology groups can position themselves to “add value” to their patients’ journey through the entire healthcare continuum. Robinson believes one key for pathologists going forward will be maintaining a “close working relationship” with client physicians in order to plan for future test offerings.
—Andrea Downing Peck
Related Information:
Companion and Complementary Diagnostics: Clinical and Regulatory Perspectives
Current Status of Companion and Complementary Diagnostics: Considerations for Development and Launch
Distinguishing Between Companion and Complementary Diagnostic Tests
Quest Diagnostics Introduces Dako’s PD-L1 Complementary Diagnostic Test to Support Bristol Myers Squibb’s OPDIVO Anti-PD-1 Therapy for Non-Squamous No-Small Cell Lung Cancer
Companion Versus Complementary Diagnostics
PD-L1 IHC 28-8 pharmDX-P150025
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 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
Mar 27, 2017 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing, Laboratory Testing, Management & Operations
CMS Director speaks at ACLA meeting; acknowledges that labs are alerting the agency to problems with Protecting Access to Medicare Act (PAMA) private payer market reporting, but did not say whether a delay in implementing either reporting or lab test fee cuts would be possible
WASHINGTON, DC—Last week, it was symbolic that, as members of the American Clinical Laboratory Association (ACLA) assembled for their annual meeting, members of the House of Representatives were preparing to vote on the first of several bills intended to “repeal and replace” the Affordable Care Act.
The symbolism comes from the fact that the nation’s medical laboratories and the United States Congress find themselves at major crossroad. For medical laboratories, the issue is the substantial cuts to Medicare Part B clinical laboratory test fees that are scheduled to take effect on January 1, 2018. Predicted by the federal Centers for Medicare and Medicaid Services (CMS) to be a total cut of $400 million in 2018 alone, many expect these Medicare fee cuts to be the single most financially-disruptive event to hit the medical laboratory profession in 25 years.
There’s a similar make-or-break issue unfolding in Congress. Republicans in the House and Senate are caught up in battles to design and pass a series of bills intended to “repeal and replace” the ACA. At their respective crossroads, it remains unclear which path forward each group will follow. (more…)
