Lab Soft News

HealthTab Launches Drugstore-Based DAT Model in British Columbia

While many of us have been preoccupied with events relating to Theranos, two entrepreneurial brothers have deployed a DAT model in a drug stores in British Columbia. Their company is called HealthTab (see: Canadian pharmacies testing do-it-yourself blood test kiosks). Below are more details:

...[P]harmacies in Canada have begun installing do-it-yourself blood testing kiosks to help patients quickly check up on their health using just a tiny amount of blood. But not everyone thinks the testing systems are a good idea. Ten pharmacies in British Columbia are now offering one blood testing system called HealthTab, which was developed by a pair of brothers from Vancouver. After a pharmacist collects a few drops of blood from a finger prick, the sample is placed in a HealthTab machine which can then measure up to 21 key health markers, including cholesterol, triglycerides, kidney and liver function, blood sugar and more....There’s no need for a doctor's requisition, although there is a fee to use the system. But the company says it can offer results in just 15 minutes rather than days, with an accuracy that’s on par with most lab testing. Users don’t need to return to their doctors for the results; the system automatically uploads them to a secured website, where users can log in from home or from their phone to see their numbers.

HealthTab uses what I would call a "stat lab" approach to generate test results in minutes using blood samples obtained by a finger stick. The analyzer is the Piccolo Xpress manufactured by Abaxis which is the only portable diagnostic device to offer a full set of CLIA waived blood chemistry tests at the point-of-care. CLIA-waved is an important distinction here because it enables the devices to be run by personnel who are not medical technologists. Here's more information about quality control of the device supplied by HealthTab and here's a link to the HealthTab test menu. You may want to compare this device to the iStat system which has been used in stat lab setting by hospitals for decades. Abbott manufactures the i-STAT analyzer and also distributes the Piccolo Xpress.

The Piccolo Xpress provides multi-chemistry panels using 0.1cc of whole blood, serum, or plasma. The system employs reagent discs for up to 15 chemistry tests each. Care providers pipette the blood sample onto the disc, insert the disc into the analyzer, and results are printed or transferred to the customer's personal dashboard in about twelve minutes (see: LAB ACCURATE BLOOD CHEMISTRY ANALYSIS IN REAL TIME). Note that the device only performs chemistry tests on serum and not hematology tests like hematocrit, hemoglobin, and WBC count. 

I am very supportive of DAT testing with the goal of engaging healthcare consumers in their own health surveillance. However, I think that the HealthTab model goes only part of the way toward an optimal lab testing solution for drug stores. The rapid results delivery is very satisfying but the absence of hematology tests is a disadvantage. There have also been some recent questions about the precision of finger stick samples (see: Rice University Researchers Publish Study about Variation in Drop-to-Drop Samples of Capillary Blood Collected by Fingerpick and Used for Clinical Laboratory Testing). 

I favor a drug store model using a venipuncture sample for both immediate processing of some stat tests and also the option of ordering additional tests sent to a remote, full-function reference lab. This is a more robust approach that can attract both DAT-oriented consumers as well as physicia-submitted test orders for their patients. I was not able to find the out-of-pocket cost of the HealthTab tests. By the way, I have yet to meet a single person who prefers a finger stick over a venipuncture. The latter are less painful, result in a larger sample, and are free of concerns about the quality.

Multitasking Surgeons; Is This a Problem or Media Hype?

A recent article in the Boston Globe raised the topic of surgeons multitasking, which is to say participating in multiple surgical procedures simultaneously. Below is an excerpt from it (see: When Surgeons Multitask: The Little-Known Practice of Concurrent Surgeries; Double-booked surgery is a troubling form of multitasking);

When you go to the hospital for an operation, did you know your surgeon might also be performing a procedure on another patient, in a different operating room, over the same scheduled time period? This practice – “two patients, two operating rooms, moving back and forth from one to the other” while relying on assistance from general surgeons or trainees – is called concurrent surgery. It’s an open secret in hospitals, but patients rarely hear about it. The Boston Globe recently investigated concurrent surgery at Massachusetts General Hospital (MGH), as well as the broader conflict in the medical community over the ethics and safety of double-booking operations....(see: CLASH IN THE NAME OF CARE). The No. 1 reason that’s given by hospitals is around efficiency and access to care, so that there's no wasted time in the operating room....It not only allows more cases in one day, but the hospitals also said, for some of these star surgeons who might have long wait lists, you can get greater access to them because they are doing more surgeries. But some doctors question its ethics....One is that there were concerns and complaints raised to him by anesthesiologists over the issues of what they considered were patient safety, and concerns around whether patients were getting the best medical care possible. And then the separate issue of patient consent -- that this practice was just known by the doctors and the nurses and the anesthesiologists and the billing clerks and everyone else. The only one who didn't know about it was the patient. It’s hard to tell how common it is because there’s scant data and hospitals aren’t talking.

Frankly, multitasking by surgeons strikes me as a new name for a historic and well-accepted practice. It surprises me, at least according to this news account, that the hospital spokespersons are not defending the practice more actively. Certainly in teaching hospitals, it has long been the practice for senior surgeons to move through multiple operating rooms with support by surgical residents and junior faculty. Often the senior surgeon would perform the most delicate parts of a procedure with the younger members "opening" and "closing" the incisions. This is precisely how surgical training programs are supposed to work. A similar system occurs in in anesthesiology with the senior anesthesiologists supervising a team of nurse anesthetists and residents in multiple ORs. The excerpt above does raise the issue of patient consent and knowledge that the senior surgeon with whom one may have consulted will not be present in the OR at all times and that residents may be performing part of the operation. I have been under the impression, perhaps naive, that most patients being cared for in teaching hospitals are aware of such arrangement. If not, such a discussion should be an obligatory part of preoperative discussions.

Pressure Mounting to Ban Pharmaceutical Direct-to-Consumer Ads

I personally favor a ban on direct-to-consumer (DTC) ads by pharmaceutical companies. They are designed by advertising professionals to manipulate consumers at a time when many are vulnerable. I also don't like the idea of patients pressuring their physicians to prescribe a particular drug. A recent article suggested that pharma is "behind" in its digital marketing expertise and such a ban could then have negative consequences for them (see: Ban on consumer ads could make pharma's digital shortcomings more costly). 

The American Medical Association (AMA), a powerful lobby that represents more than 200,000 doctors and medical students in the United States, is calling for a ban on direct-to-consumer ads that pitch prescription drugs and medical devices (see: AMA Calls for Ban on Direct to Consumer Advertising of Prescription Drugs and Medical Devices). Noting that the US is one of only two countries in the world that allow such ads, the AMA says that "direct-to-consumer advertising...inflates demand for new and more expensive drugs, even when these drugs may not be appropriate." The AMA's stunning reversal...arguably couldn't come at a worse time for pharma companies. Many of them find themselves under increased scrutiny over prescription drug pricing and concerns around anti-competitive behavior.

At the same time, the industry as a whole has been leaning heavily on advertising. Citing research from Kantar Media, the AMA pointed out that drugmakers are now spending $4.5bn a year on ads, a figure that has increased by 30% in the past two years alone. With pharma out of favor with consumers and politicians, a ban on direct-to-consumer advertising seems possible, and if one was implemented, pharma companies would face significant challenges marketing their wares. Unfortunately, pharma's digital efforts have been falling short. According to recent research by Deloitte Consulting and the Gerson Lehrman Group, pharma companies are largely underinvesting in digital outreach to physicians. They invested just $1.4bn in online advertising last year, just a quarter of what they spent on ads overall and an amount that far lags other industries such as retail and financial services. The result: there is a significant trust gap with physicians, 75% of whom lack trust in the information provided by pharma.

Here's some background about pharma companies and their previous marketing efforts. In the past, pharma companies would market directly to physicians with so-called detailers -- sales reps who would call on physicians in their offices (see: As Physicians Lose Clout, Pharma Companies Redirect Sales Calls). This program started to get too costly so pharma turned, in part, to e-detailing and e-sampling which is basically digital marketing How E-Detailing May Lead to Greater Knowledge by Physicians about Drugs; E-Sampling: Another Blow to the Future of Pharma Sales Reps). As more physicians were employed by hospitals, some of the detailers were repurposed as "physician liaisons" who called on hospitals (see: Physician Liaisons: Former Pharma "Detailers" Now Marketing Physician/Hospital Services).

Concurrently, the pharma companies also turned to DTC ads, often finding them more effective than physician calls and thus an important marketing channel. Some of the larger pharma companies now spend more on marketing than on R&D (see: Confirmation that Big Pharma Spends More on Marketing than R&D). Another marketing channel for the companies, social media, is being scrutinized by the FDA because of the potential for consumers to receive misinformation about drugs (see: FDA Issues Warning Letter to Drug Company about Use of Instagram; Pharmaceutical Companies Continue to Experiment with Social Media; GlaxoSmithKline Mines Social Media for Information about Adverse Drug Events). 

I personally favor restricting the marketing activities of pharmaceutical companies to web sites and ads in medical journals that would be restricted to pure science accompanied by links to the relevant medical literature. I would also encourage and fund high quality web sites that address key therapeutic issues such as the substitution of generics for proprietary drugs.

Problems with Theranos' Lab Proficiency Testing; Another Layer of Difficulty?

John Carreyrou's bold investigative piece about Theranos that appeared in the Wall Street Journal has been widely quoted (see: Hot Startup Theranos Has Struggled With Its Blood-Test Technology). However, relatively unnoticed and deep in the article were his comments about possible proficiency testing (PT) errors by the company. If they prove to be correct, they could add another layer to the Theranos difficulties. Here's the relevant quote from the article:

In early 2014, Theranos split some of the proficiency-testing samples it got into two pieces, according to internal emails reviewed by the Journal. One was tested with Edison machines and the other with instruments from other companies. The two types of equipment gave different results when testing for vitamin D, two thyroid hormones and prostate cancer. The gap suggested to some employees that the [company analyzer] Edison results were off, according to the internal emails and people familiar with the findings....Former employees say [CEO Sunny Balwani]...ordered lab personnel to stop using Edison machines on any of the proficiency-testing samples and report only the results from instruments bought from other companies.The former employees say they did what they were told but were concerned that the instructions violated federal rules, which state that a lab must handle “proficiency testing samples…in the same manner as it tests patient specimens” and by “using the laboratory’s routine methods.”

In its everyday business at the time, Theranos routinely used Edison machines to test patients’ blood samples for vitamin D, the two thyroid hormones and prostate cancer, the former employees say. In March 2014, a Theranos employee using the alias Colin Ramirez alleged to New York state’s public-health lab that the company might have manipulated the proficiency-testing process. Stephanie Schulman  director of the public-health lab’s clinical-lab evaluation program, responded that the practices described by the anonymous employee would be a “violation of the state and federal requirements,” according to a copy of her email. What the employee described sounded like “a form of PT cheating,” Ms. Shulman added, using an abbreviation for proficiency testing. She referred the Theranos employee to the public-health lab’s investigations unit. The New York State Department of Health confirms that it got a formal complaint in April 2014 “in regard to testing practices at Theranos” and forwarded it to the Centers for Medicare and Medicaid Services.

Here's a definition for proficiency testing (PT) according to CLIA (see: CLIA; Proficiency Testing; Do's and Don'ts):

Proficiency testing or PT is the testing of unknown samples sent to a laboratory by a CMS approved PT program. Most sets of PT samples are sent to participating laboratories three times per year. After testing the PT samples in the same manner as its patient specimens, the laboratory reports its sample results back to their PT program. The program grades the results using the CLIA grading criteria and sends the laboratory scores reflecting how accurately it performed the testing. CMS and accreditation organizations routinely monitor their laboratories’ performance.

So, to summarize, here's how I interpret Theranos' PT problems which are distinct from it's challenges relating to the validation and accuracy of its analyzer or its promise to perform multiple tests inexpensively using only a drop or blood:

• The company is reported to have split PT samples into two parts and tested one on its own analyzer, Edison, and the other on a standard analyzer. According to the story, this may have been an attempt to validate its own instrument. Aside from being against federal regulations, the approach also seems to make little sense because the true analyte values of the PT samples were unknown. Values between the two instruments, of course, could be compared.
• If the company was running vitamin D, two thyroid hormones and prostate cancer assays on the Edison analyzer but not using the same instrument for PT testing, the company would be out of compliance with federal regulations. Both this and the previous sample splitting could be the basis for lifting the lab's CLIA license or even worse under CLIA regulations. 
• According to the article, all of these issues appear to have been the basis of a formal complaint to CMS via the New York State Department of Health. Some disciplinary action might be forthcoming if the complaints prove to be correct.

Some Thoughts about the Uberization of Ambulatory Health Services

I  posted a previous note about some general aspects of the uberized economy with suggestions about how it might apply to staffing in pathology (see: Relevance of an "Uberized" Economy for Healthcare and Even Perhaps Pathology). I also posted a blog note more than five years ago about how software was causing disintermediation of multiple industries (see: Digital Self-Publishing Promoted by Amazon and Its Kindle e-Reader) A second key aspect of uberization, in addition to harnessing the shared labor market and the gig economy, is the substitution of software for human intermediaries in business processes. The software wrings both time and cost out of these processes, improves the consumer experience, and reduces costs. Consider how the sophisticated Uber software makes transportation in the city much more pleasant. This is all software-driven.

A recent article discussed the uberization of the banking industry with the deployment of new apps (see: The Uberization of Banking). For example, peer-to-peer lending can be accomplished more quickly and less expensively than applying for a bank loan. I want to take some of these same arguments and apply them to a discussion of the uberization of ambulatory care (see: The Uberization of Healthcare). My discussion in a note yesterday about how Walgreens is setting up a first-tier, ambulatory care system with complex software support (see: Walgreens Launches Major Effort to Generate Patient Health Information). 

One of the basic pillars in the uberization of ambulatory care will be broader availability of physician virtual visits for low-intensity problems. In the case of the Walgreens business model and their walk-in Healthcare Clinics, the on-site professional is usually a nurse practitioner. By way of contrast, the Cleveland Clinic is now offering telemedicine visits using family practice physicians for $49 for all Ohio residents (see: Details of Cleveland Clinic's MyCare Online Virtual Telemedicine Visits).

Two powerful incentives are at work to stimulate expanded use of physician e-visits by hospitals even in those systems that are not particularly innovative. The first is that telemedicine visits do not require incremental investments in bricks-and-mortar in order to expand physician work effort. This is particularly important as the number of patients seeking care in the country expands under the ACA. I also believe that e-visits make more efficient use of physician time and effort, particularly as physicians become more comfortable with the technology. This is particularly important for participation by specialists like neurologists who are in short supply and for whom appointment wait-times can extend to many months. 

At the present time, the range of services available during a physician e-visit beyond face-time are limited. One is the generation of e-prescriptions. Recall from the above discussion that we are only at an early stage in the deployment of software in support of the uberization of ambulatory care. Envision instead an e-visit that would include monitoring of patient vital signs using sensors attached to the patient's smart phone and the ability to order both lab tests and radiology studies for virtual patients.

Walgreens Launches Major Effort to Generate Patient Health Information

Walgreens' relationship to Theranos has been a recent distraction that has obscured other news about the company's overarching digital and telehealth strategy. I began blogging six years ago about the emergence of what was then called "walk-in clinics" in retail pharmacies (see: A New Version of the Walk-In Retail Health Clinic Launches in Walgreens). Walgreens has now launched its Walgreens Connect app which is a gateway to its Balance Rewards program (see: Competition heats up for patient-generated health data). Details are provided in the following excerpt from the article:

The number of tools to track patient health data has exploded in recent years, and the race to access that information is heating up as well. Walgreens this week launched its Walgreens Connect app, which allows participants of its Balance Rewards program to get 20 points each time they take their blood pressure or test their blood sugar with a branded monitor that can be purchased in-store. The move is one prong of Walgreens' larger digital and telehealth strategy, which also includes offering telemedicine services through its partnership with [on-line physician service] MDLive. The pharmacy giant this week expanded that relationship into 20 additional states, bringing the total number to 25. It also has a partnership with WebMD to offer virtual wellness-coaching sessions....Data collected through the Walgreens Connect app is stored in the cloud through a partnership with Qualcomm. Balance Rewards points can be redeemed for money off store purchases....Software companies like [digital health platforms] Welltok and Validic have built a business model of creating a single entry point for providers, insurers and employers to access a wealth of patient data from sources ranging from FitBit to dLife. Other innovators are trying to make the data more usable for providers so they don't become overwhelmed by the sheer volume of it. Stage 3 of the meaningful-use rules also encourages the use of patient-generated data in electronic health records.

This is the way I see this retail pharmacy/healthcare consumer "ecosystem" developing, at least in the short term. Health conscious consumers will purchase a wrist monitoring device like FitBit or have access to an app on their smartphones like the Apple Health app. They may also install on their smartphones the new Walgreens Connect app which gives them access to the Balance Rewards program and earn points toward store discounts when they monitor their blood sugar or blood pressure on devices purchased at Walgreens. In time, these physiologic monitoring apps will be integrated into smart phones. The Walgreens Connect app is linked to the cloud for data storage using Qualcomm technology. In a previous note, I discussed home monitoring of discharged hospital patients for cost savings using Qualcomm technology (see: Home Monitoring of Discharged Patients by Hospitals for Cost Savings).

I view lab testing as an emerging and essential component of the health ecosystem of the retail drug store chains. It should come as no surprise, therefore, that Walgreens established a relationship with Theranos which is now on hold due to uncertainty about the quality and maturity of the Theranos technology (see: Walgreens Scrutinizes Theranos Testing). I have grave doubts whether the Walgreens/Theranos partnership will survive. If severed, Walgreens might consider turning to Quest or LabCorp as a substitute for the Theranos lab testing services. Both of these national reference laboratories have demonstrated an interest in direct access testing (DAT) (see: LabCorp to Offer Direct Access Lab Testing (DAT) to Consumers; Sonora Quest Competes with Theranos in Arizona with DAT Services). Certain in my mind is that both CVS and Walgreens are building what will become an important primary care network staffed mainly by nurse practitioners (NPs) but also with access to virtual physician visits (see: A Solution to the PCP Shortage: Nurse Practitioners; Future key Role of Nurse Practitioners in Primary Care; Not All NPs and PAs Choose to Work in Primary Care; What's the Problem?).

Cleveland Clinic Lowers Health Insurance Costs with Preventive Medicine

I have long been impressed with the preventive medicine efforts undertaken at the Cleveland Clinic under the leadership of CEO Toby Cosgrove. I was particularly impressed when the hospital began to refuse to hire smokers about five years ago (see: Want a Job at the Cleveland Clinic?: Smokers Need Not Apply). It's telling that relatively few hospitals have followed their lead in this matter, preferring a more passive approach to preventive medicine for their employees. In a recent article, Dr. Cosgrove discussed in some detail the success that the Cleveland Clinic has enjoyed with its preventive medicine programs (see: Healthcare's ‘Magic Bullet’ Still Working). Below is an excerpt from the article;

As a healthcare organization, we believe that we have to be a model of appropriate healthcare, which means building a culture of wellness, promoting personal responsibility, and rewarding healthy lifestyles. We no longer hire smokers, while providing free smoking cessation programs to current employees. We offer free Weight Watchers and gym memberships. We have weekly farmers markets on campus throughout the summer and fall. We’ve removed fried foods from our cafeteria and sugared drinks from our vending machines...[W]e offer discounts for physical activity or for enrollment in a disease management program. Our employee health plan covers more than 82,000 employees and their family members....When we floated this concept, we expected a flood of outrage. Instead, we have found tremendous participation – 55 percent of those eligible for a disease management program have signed up. As I pointed out at our 10th Annual Cleveland Clinic Obesity Summit earlier this month, the results have been impressive:

• Our organization’s body-mass index (BMI) has steadily decreased.....
• Prior to 2010, our health insurance costs were going up at 7.5 percent annually; it is now just under 3 percent, which saves us money and allows us to drive down the cost of care to our patients.
• We’ve seen a 20 percent reduction in hospitalization among of those in disease management programs, compared to those not in disease management program....
• Just 5 percent of our employees are smokers.

For me, one of the most interesting parts of this story is that health insurance costs for the Cleveland Clinic have declined by about 4.5% for its 82,000 employees. That's an impressive savings. Clearly much of it is related to the 20% reduction in hospitalization among those in disease management programs. Where, you may ask, are these savings allocated? According to Dr. Cosgrove, they are used to "drive down the cost of care [for the Cleveland Clinic] patients." What about passing the savings on to the employees who are leading healthier lives? Well, this might be viewed as unfair, discriminating against those who view participation in the disease management programs as intrusive or impinging on their right to privacy.

In a way, though, helping to reduce patient costs helps the Cleveland Clinic employees because it allows the organization to keep its costs in check, attract more patients, and increase the number of employees. Those employees who are cajoled into a healthier lifestyle (e.g., those who quit smoking under pressure) can perhaps learn to appreciate their healthier status in time. I am also enthusiastic about the idea of discounts on healthcare premiums for measured physical activity. It may just be wordplay but you are rewarding the active rather than penalizing the passive.

Proposed Characteristics of the Impending Reform of Diagnostics

A recent article in Fortune suggested that, despite the bumps in the road for Theranos, Elizabeth Holmes' vision was probably correct in terms of the need for reform in the clinical lab industry (see: Despite Clamor Surrounding Theranos, The Entrepreneur's Vision Of Transforming Diagnostics Is Near). Below is an excerpt from an article:

Despite the recent controversy with Theranos, transformative changes in health care diagnostics are here to stay. The entrepreneur’s vision for radically improved solutions is out of the genie’s lamp, and consumerized, affordable, and convenient diagnostics will soon be an ongoing part of millions of people’s health and wellness lifestyle. Over the past few weeks, Theranos founder Elizabeth Holmes has been criticized for missteps and misrepresentations about blood diagnostic technology produced by her company. Whether or not these allegations turn out to be true, the Theranos story should not distract investors and the industry from the real prize: consumer-friendly blood diagnostics, anyone can afford and get access to, so people can better monitor and improve their health.....[T]he field of blood diagnostics is in the midst a revolution. As blood diagnostic technology rapidly advances, one of the biggest innovations is with user experience – bringing minimally invasive diagnostics to your pharmacy, your home, your office and your smart phone. In five years time, frequent...diagnostic blood tests will be an integral part of managing one’s health. Without ever stepping foot into a clinic, people will be able to safely and accurately monitor lipid parameters and track for certain biomarkers of disease, all from the comfort of home. Even more exciting is what happens when these tests become truly affordable, accessible anywhere, and analyzed by intelligent monitors. Some obvious opportunities: early detection of disease, incremental behavior change, and hopefully longer healthier lives.

I agree with the need for transformative changes in the clinical lab industry and diagnostics articulated in this article. Hence and to kick off this discussion, I thought that it would be useful to generate a simple list of what I think might be key descriptors that could characterize the reform process:

• Affordable.
• Accessible.
• Comfortable.
• Understandable/analyzable reports.
• Useful in terms of health improvement and disease avoidance.
• Risk minimization; no inaccurate data and avoidance of iatrogenic injury

As I developed this list, I was striving to come up with terms that the lay public would understand and relate to. After all, they will be major drivers of the reform effort. After I completed the list and understanding that it will be subject to subsequent revisions, it occurred to me that my idealized diagnostic system was far removed from our current one. In other words, our healthcare system that has evolved over many decades has been designed largely by and for physicians and healthcare executives. It's far from being consumer-friendly. The reform of diagnostics will obviously move in this direction, largely fueled by the profits that can be achieved by entrepreneurs who develop companies and apps that support greater consumer engagement in diagnostics and healthcare delivery.

I want to make one more brief point in terms of the affordability of diagnostics. Most lab tests are quite inexpensive to perform because they are highly automated. The price for tests that may be seen by self-pay consumers is relatively high because of the markup of these prices by hospitals, often to compensate for other services that are run at a loss. As lab testing becomes unmoored from hospital spread sheets as is the case with direct access testing (DAT), the prices will move closer to their true, and lower, cost.

Perhaps the Theranos Analyzer Is Not that Revolutionary

A very insightful article about Theranos by Thomas Lee was recently published in the San Francisco Chroncle. It makes some very telling points regarding the company's relationship to the FDA (see: Theranos CEO Elizabeth Holmes needs to grow up, and fast). Here is an excerpt from the piece:

The Food and Drug Administration had granted 510(k) approval to Theranos’ testing system for herpes.“FDA’s review process for 510(k) notifications is widely recognized as one of the most rigorous regulatory hurdles in the world for evaluation of the performance and accuracy,” the company said. “Today’s announcement demonstrates that Theranos has met that standard and is an important step in Theranos’ mission to ... [empower] individuals everywhere with information to live healthier lives.”

Given the breathless tone of the statement, you would think that Holmes had just won the Nobel Prize for Medicine. But it turns out 510(k) approvals are pretty standard in the medical device industry. And contrary to what Theranos suggested, 510(k) does not mean the agency has blessed the “performance and accuracy” of the company’s technology. It simply means that Theranos’ tests are pretty similar to a previously FDA-approved device on the market.“The 510(k) clearance is not a determination that the cleared device is safe or effective,” according to an Institutes of Medicine report, commissioned by the FDA itself.

Continuing in this same direction, here are quotes from the FDA's actual 510(k) report (see: 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY):

The TheranosTM HSV-1 IgG Assay is a chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to herpes simplex virus type 1 (HSV-l) in human serum, in K2-EDTA anti coagulated human plasma from venous blood, and in human fingerstick K2-EDTA anticoagulated whole blood obtained with the Theranos Capillary Tubes and Nanotainer Tubes. 

AND

The Theranos HSV-1 IgG Assay reagents are packaged in a ready-to-use pouched cartridge and are designed to be used directly. No additional preparation of reagents is required. The Theranos HSV-1 IgG Assay is intended to be run on the TheranosTM TSPU [Theranos Sample Processing Unit] Device only.

Let me repeat the key sentence from Lee's story above: [The 510(k) approval for the Theranos herpes test] means that Theranos’ tests are pretty similar to a previously FDA-approved device on the market. What the FDA has approved is a chemiluminescent test for herpes running on the Theranos analyzer, referred to in the report as the Theranos Sample Processing Unit (TSPU), with a "pouched cartridge" containing reagents and into which an aliquot of serum is injected to measure the herpes IgG antibody

FDA tends to be a conservative in assessing new lab testing devices which is appropriate given that it is tasked with protecting the health of citizens. Approval via 510(k) path requires "substantive equivalence" with a "predicate device" (see:The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]). The idea of a chemiluminescent immunoassay and a pouched cartridge sounds similar to current analyzer technology. Theoretically, the idea that the Theranos assay uses only micro-aliquots of blood could be construed as a radical approach to lab testing. Here again, however, there are precedents dating back decades. Blood is commonly obtained from premature infants and newborns with a heel stick and with blood drawn into a capillary tube. Here's a link to a list of the pediatric test menu in one hospital that can be performed today after drawing micro-liter amounts of serum/plasma (see: Pediatric Blood Specimens).

In my opinion, what is remarkable about the Theranos business model is the emphasis on direct access testing (DAT) and using the Walgreens health center as blood drawing stations. The emphasis of the company on broad and inexpensive access of healthcare consumers to their lab test results is highly commendable. However, the evidence presented here suggests that the Theranos analyzer using test cartridges may be less revolutionary than evolutionary.

Upcoming Free Webinar: Clinical Informatics Fellowships and their Impact on Opportunities in Pathology Informatics

The highly regarded webinar series sponsored by the Association for Pathology Informatics (API) and Sunquest Information Systems continues with a lecture by Dr. Bruce Levy who is a pathology faculty member at the University of Illinois at Chicago College of Medicine. Here's the title of his lecture: Clinical Informatics Fellowships and their Impact on Opportunities in Pathology Informatics. The date is November 10, 1:00 PM – 2:00 PM ET. Here's the link to register for the session and here's the link to Dr. Levy's fellowship web page.

Previous sessions of the 2015-2016 webinar series included the following: (1) Dr. Liron Pantanowitz lecturing on How Digital Pathology Will Change the Workflow of Surgical Pathology on September 22, 2015; (2) Dr. Walter Henricks lecturing on ONC’s Laboratory Results Interface (LRI) and Laboratory Orders Interface (LOI) Implementation Guides and Challenges in LIS-EHR Information Exchange on October 7, 2015.

Dr. Levy's presentation will be of great interest to any pathology resident who is contemplating a career in pathology informatics or practicing pathologists with a special interest in the field. Fellowships in the field are relatively new but such credentialing is increasingly important in a job search.