Lab Soft News

The "Orderly" Retreat from Bedside Diagnosis

When I started medical school more than 40 years ago, it was generally acknowledged by the clinical faculty that bedside diagnosis was a dying art, supplanted largely (even at that time) by a broad array of lab tests and medical imaging studies. It was occasionally remarked by them that the art of bedside diagnosis was alive and well in England where it was still held in high regard.

I published a previous note about the Biosite purchase by Beckman Coulter (see: Beckman Coulter to Acquire Biosite). An article that covered this story (see: Beckman to Acquire Test Maker Biosite) made reference to the Biosite pipeline of new lab tests as one of the reasons that Beckman Coulter viewed it as a worthy catch. Below is an excerpt from it (boldface emphasis mine):

The companies said they began working together four years ago on an indicator of congestive heart failure [BNP]. Biosite saw a need for the test to run on an automated system, such as those sold by Beckman. "We got together and found a way to convert that test to a format that would run on our installed base of automated platforms," Mr. Garrett said. The companies launched the test, B-type Natriuretic Peptide, or BNP, about three years ago. Beckman said it also hopes to benefit from Biosite's pipeline of new tests, covering acute coronary syndrome, sepsis, abdominal pain and other conditions. In a hospital, the cost of immunoassay tests can run as much as $20, compared with perhaps $1.50 or less for a routine cholesterol or glucose test.

In this article, my eye was immediately drawn to the reference to emerging lab tests for acute coronary syndrome, sepsis, and abdominal pain. It's clear to me that the next frontier for the clinical lab will be multiplexed syndromic diagnosis, as opposed to disease diagnosis. I am defining syndrome here as "a group of signs and symptoms that collectively define or characterize a disease or disorder -- signs are objective findings such as weakness, and symptoms are subjective findings." To this list of broad syndromes I would add other common ones such fever of unknown origin (FUO), chest pain, and syncopal (fainting) episodes. Multiplexed testing is defined as performing multiple lab test simultaneously using a single serum sample (see: All in one and one for all: multiplex testing).

The modus operandi for physicians in the future, I believe, faced with a patient with acute abdominal pain, for example, will be to order the "abdominal pain" test panel STAT. This panel will be composed of a set of biomarkers selected to diagnose the most common diseases and conditions that present with a so-called acute abdomen. I anticipate that the physician will then perform a rapid physical exam to assess the acuteness of the problem followed, in short order, by the ordering of a series of preliminary medical imaging studies. In such a rapid workup, the physical exam will be designed primarily for triage purposes and to select the most relevant lab and imaging studies rather than to arrive at a precise diagnosis for the patient.

Misys Plans Shake Up Raleigh Real Estate Market

Misys Healthcare has been beset with a number of problems lately, many of which have been covered in Lab Soft News. In January, the company's CEO, Tom Skelton, resigned in the wake of "unacceptable" performance. The company's U.S. headquarters are located in Raleigh, North Carolina. We now learn from a Raleigh business publication that these events and the Misys retrenchment plans are roiling the local real estate market (see: Misys' Forum space could hit market) Below is an excerpt from the article (boldface emphasis mine):

A management shakeup that's roiling Misys Healthcare's headquarters in north Raleigh may send tremors through the commercial real estate market surrounding it. Misys Healthcare in December 2005 signed a binding pre-lease agreement for 60,000 square feet of office space that spurred construction of the new Forum V building ...But sources now say Misys has started quietly marketing the Forum V space to other companies for sublease because Misys will no longer need it when the building....Millions of dollars are at stake for Misys Healthcare's bottom line. The deal the division signed in 2005 is valued at $63.5 million over 10 years and ranked as the second largest office lease of the year....Skelton was replaced in February by former Kodak executive Roger Davenport. On March 8, Misys CEO Mike Lawrie announced a new strategy for the company that includes more focus in health care on its physicians practices, consolidation of its software development operations around the world, the sale of its Sesame division and a cost restructuring expected to improve its financial margin....Misys Healthcare, a health-care software and services company, has about 800 of its 2,800 worldwide employees based in The Forum office park.

The ramifications of the above reference to more focus on its physician practices is not entirely clear. For example, its Optimum product was described by the company in the following way in 2004 (see: Misys introduces Misys Optimum to support physicians and caregivers across the continuum of care)

Misys Optimum is a comprehensive suite of world-class clinical systems and services uniquely positioned to support community-wide health care with data sharing among acute, ambulatory and post-acute care providers, affiliated and non-affiliated. Approximately 92.000 physicians and more than 100.000 nurses in 18.000 medical practice locations, 1200 hospitals and 600 home care organisations across North America rely on Misys solutions to improve organisational efficiencies and overall productivity.

Misys first arrive in Raleigh, North Carolina, in late 1997 with the $923 million purchase of Medic Computer Systems. Medic was a physician office practice management system (PMS). It appeared to me at that time that the Misys strategy was to provide software for both healthcare systems and the physician office market. However, providing support across the entire "continuum of care" is a rather tall order, particularly for a company experiencing both leadership and financial challenges. Moreover, the hospital and the physician office are quite different healthcare software markets. It's possible, therefore, that such a goal is unrealistic. However, once it has been publicized, how does one back off from it gracefully and which of its existing product lines does the company then favor? I suspect that answer can derived from the financial success in the market of its various offerings.

Update on 3/29/2007 at 12:38 p.m.

Also see Misys' focus is back on doctors.

A Quick Look at CalRHIO

Mr. HIStalk recently reported on the demise of the Santa Barbara RHIO that had been headed by Dr. David Brailer. You may recall that he previously served as the National Coordinator for Health Information Technology in the Department of Health and Human Services. I have posted a number of previous notes about RHIOs. I am pessimistic about the likelihood of success for these organizations that seek to integrate health information across a geographic region. In part, my pessimism is prompted by the fact that the participating health systems themselves are usually inadequately integrated. Below is an excerpt from the note:

[Submitted Comment] For all of the hype that the Santa Barbara RHIO has received over the years, it was recently unplugged! Funny how everything has changed so quickly - time was when David Brailer would tout this as his pet project. Can you say CHIN revisited?"

[Mr. HIStalk response]... [I]t's dead, having accomplished little except spending grant money and getting everyone worked up over Interoperability Strikes Back: Return of the CHINs. The takeaway: what killed it was privacy concerns and a lack of incentives for the two participating organizations to pay for its upkeep. Actually, what probably sealed its demise was the far broader CalRHIO initiative, which made this one obsolete before it ever got going. Unfortunately for the Santa Barbara group, others did it better with the benefit of hindsight.

Note to my younger readers: CHIN stands for Community Health Information Network. The concept had some traction in the 1990s. I think that all such entities quietly disappeared, as will RHIOs, but not without a number of vendors and consultants feeding at this trough for a few years.

Mr. HIStalk suggests that the fate of the Santa Barbara RHIO was sealed by the emergence of CalRHIO, which I had not personally been tracking. According to a recent report (see: CalRHIO reviews bids to build $100M health care data system for state), this organization is planning to build a $100 million healthcare IT network to serve California. On March 13, it was announced that CalRHIO had selected Medicity and Perot Systems to build their statewide network. As part of my background reading about CalRHIO, I came across a list of its Board of Directors. Below is the list, including its ex-officio representatives. culled from the CalRHIO web site.

Board of Directors

• Molly Coye, M.D., CEO, Health Technology Center (Interim Chair)
• Linda Ackerman, attorney, staff counsel, Privacyactivism.org
• Ronald Bangasser, M.D., practicing physician, Beaver Medical Group
• Eric Book, M.D., chief medical officer and sr. vice president, Blue Shield of California
• Don Crane, CEO, California Association of Physician Groups (CAPG)
• Duane Dauner, president, California Hospital Association
• Seth Fearey, vice president and COO, Joint Venture: Silicon Valley Network
• Patrick E. Fry, president and CEO, Sutter Health
• Lark Galloway-Gilliam, executive director, Community Health Councils, Inc.
• Jennie Chin Hansen, board member, AARP
• Ronald W. Jimenez, M.D., associate medical director, clinical informatics, Santa Clara Valley Health and Hospital System
• Barbara Johnston, executive director, California Telemedicine & eHealth Center (CTEC)
• Charles Kennedy, M.D., vice president, Clinical Informatics, WellPoint, Inc.
• Robert Klein, M.D., associate executive director, The Permanente Medical Group, Northern California
• Peter Lee, president and CEO, Pacific Business Group on Health
• Chris Ohman, president and CEO, California Association of Health Plans
• Tom Priselac, president and CEO, Cedars Sinai
• Jo Ellen Hylind Ross, president and CEO, Lumetra
• Tom Williams, executive director, Integrated Healthcare Association
• Mark Windisch, senior advisor, L.A. Care Health Plan

Ex-Officio Members

• Lesley Cummings, executive director, the Managed Risk Medical Insurance Board (MRMIB)
• Cindy Ehnes, director, California Department of Managed Health Care
• Jeff Flick, regional administrator, the Center for Medicare and Medicaid Services (CMS) Region IX
• Don Holmquest, CEO, CalRHIO

Here is the mission statement for CalRHIO copied from the organization's home page:

CalRHIO - is a collaborative effort to incrementally build the structure and capabilities necessary for a secure statewide health information exchange system that enables California’s health care providers and patients to access vital medical information at the time and place it is needed.

So what do we have here? First of all, its an organization whose mission is to "enable California’s health care providers and patients to access vital medical information at the time and place it is needed."   The Board of Directors has 20 regular members and  four ex-officio members. By my count, the group contains six physicians (boldface) but five of them are "suits" serving in an executive capacity with health systems and insurance companies. One of the total of 24 on the Board is very prominently labeled as a "practicing physician" to make the point and none are identified as nurses. On the patient advocacy side, one potentially in this category is labeled as a board member of AARP but I would also personally place this individual into the "suit" category.

Can you see where I am headed here? If this RHIO ever managed to go "live" on some sort of robust integrated system, the chances of which I think are quite slim, the further likelihood of if ever providing any value to the physicians and nurses of the state who may want to use it are even slimmer. I suspect, based on the composition of the Board, that the goals of CalRHIO are primarily to exchange healthcare financial information -- note the carefully selected references in the mission statement to "California healthcare providers" and to "vital medical information." No use of the word "clinical" here at all. At least with CHINs, one of the major avowed purposes was to share clinical information across a region.

Sheldon Dorenfest Blames Healthcare IT Vendors for "Overselling" Their Systems

I had personally lost track of Sheldon Dorenfest, one of the early and prominent figures in healthcare computing, until I came across a recent article in Modern Healthcare, an excerpt of which is presented below (see: Dorenfest discusses four generations of health IT):

Sheldon Dorenfest has been a familiar face at the HIMSS shows for decades, going back to when the trade group was called the Hospital Management Systems Society and was still affiliated with the American Hospital Association. Dorenfest sold his healthcare IT marketing database business to HIMSS Analytics in 2004...."The first time I spoke at a HIMSS meeting it was in Atlanta in 1983 when there were 300 people at the whole meeting," Dorenfest recalled....

Over those years, he said, he's seen four generations of technology applied to healthcare recordkeeping and transmission.... And during that time, he said, the adoption track has been littered with the wreckage of systems that were implemented too soon for the underlying technology—systems that only added to healthcare's complexity, not lessened or alleviated it."I've seen the industry spend so much money and not yet gain the efficiency that is to come from a good IT and work process improvement system," Dorenfest said. He lay most of the blame on vendors. "They're still overselling their systems and oversimplifying the implementations. I can't tell you how many million-dollar, $10 million-, $20-million (failure) stories I've seen."

I was interested in Dorenfest's assertion that healthcare vendors are to blame for causing the landscape to be littered by "wrecked" systems. Let's conduct a thought experiment to see if he is right. Let's say a shabbily dressed individual approaches a passerby on the street and sells him the Brooklyn Bridge. Where do we place the blame for such a foolish transaction? I would say that we assign at least some of the blame to the purchaser for naiveté at best and stupidity at worst. Now, let's transform the seller to a well-dressed smooth-talker who wines and dines the passerby over a period of weeks or months. He also tells him how smart he is and how famous he will be as the owner of such a landmark? Whom do we blame in this latter case? I again assign a large portion of the blame to the unsophisticated buyer.

Most large healthcare IT purchases are initiated and executed by C-level executives who have never directly cared for patients and may have an imperfect understanding of the myriad processes occurring in the delivery of healthcare services and supported by EMRs. If they are advised about the purchase at all by physicians or nurses, they are frequently those with "informatics" titles who may have an important career stake in the purchase and deployment of a new and "dazzling" EMR. Without willing and frequently unsophisticated hospital buyers, the vendors of such systems would be out of luck.

To nail down this point, let's look at the success rate of LIS, RIS, and pharmacy systems over the last decade. A total failure for such systems is almost unimaginable, which is to say it rarely if ever occurs. The decision-makers for the selection  and purchase of these systems are those hospital personnel who will work in the trenches and use them on a daily basis. They simply have to get the process right in order to survive. Both vendors and purchasers know what is at stake here and they jointly ensure that these ancillary systems both provide value and work efficiently. For various reasons, the same conditions don't seem to apply to hospital EMRs.

Beckman Coulter to Acquire Biosite

Here's some breaking news about an acquisition by Beckman Coulter (see: Beckman Coulter Agrees To Acquire Biosite Incorporated For $1.55 Billion In Cash. Below is an excerpt from the article (boldface emphasis mine):

Beckman Coulter...and Biosite... announced today that they have entered into a definitive merger agreement under which Beckman Coulter will acquire all of Biosite’s outstanding common stock in a cash tender offer of $85.00 per share, or approximately $1.55 billion on a fully diluted share basis...Scott Garrett, Beckman Coulter’s President and Chief Executive Officer, said, "This is an exciting transaction that grew out of our successful relationship with Biosite over the past four years in the area of B-type Natriuretic Peptide (BNP), a test that aids in the diagnosis, risk stratification and assessment of severity of heart failure and the risk stratification of patients with acute coronary syndromes. It will position Beckman Coulter as a leading provider of immunoassay tests, especially within cardiac diagnostics.....A major source of value in the transaction is our ability to leverage our global commercial infrastructure and installed base to expand sales of Biosite’s immunoassay tests, including BNP. Longer term, we will have significant opportunities to leverage Biosite’s pipeline of novel diagnostic tests across our large installed base of automated systems in hospital laboratories. Additionally, the transaction will expand our offerings into near-patient testing, providing additional markets for many of our highest-value tests."

Siemen's Commitment to In-Vitro Diagnostics

Robert Michel of the Dark Daily reported recently on a laboratory management meeting conducted by Siemens Medical Solutions Diagnostics in Stratford-upon-Avon, England (see: Integrating In Vitro and In Vivo Diagnostics). This was the third annual Process Management Meeting convened by Siemens for its laboratory customers in the U.K. Below is an excerpt from his article:

One session at this meeting was targeted specifically at the topic of integrating in vitro and in vivo diagnostics. In a point/counterpoint discussion, [the moderator] challenged Nico Arnold, the newly- appointed Head of Europe for Siemens Medical Solutions Diagnostics, to lay out the company’s strategy and give everyone in the meeting a better understanding of how Siemens’ intends to proceed to achieve integration of these two diagnostic disciplines. Nico Arnold’s message was simple and clear. “Going forward, laboratory customers of Siemens will see a continued commitment to both the latest in lab test technology and a high level of value-added service,” he stated. “With its recent acquisitions, Siemens has become the world’s largest player in immunoassays and is one of the top three largest in vitro diagnostics (IVD) manufacturers globally. Siemens fully intends to be at the forefront of laboratory medicine, just as it is a leader in radiology and imaging.”

I have provided extensive previous coverage of Siemens and its purchase of two IVD companies -- DPC and Bayer Diagnostics. The above quotation from Nico Arnold should be reassuring to those clinical lab professionals who may be apprehensive about what Siemens has in store for them and to what extent the company may favor imaging over in-vitro diagnostics. However, let's be realistic. No one in the audience really expected him to say that Siemens intended to run its newly acquired companies into the ground.

Large multinational companies like Siemens are very focused on the bottom line as well as the contributions of corporate acquisitions to their financial well-being. The key question for lab professionals regarding Siemens going forward is the following: in what way will their professionals lives be different with Siemens as the owner of the former Bayer Diagnostics and DPC? Following are some of my current ideas about this question. I will expand the scope of my comments to include both Siemens and GE since they both seem to be moving in the same direction:

• The approach of both Siemens Medical Solutions Diagnostics and GE Healthcare to diagnostic medicine will be more integrative. This has been apparent in the molecular medicine concept coined by Siemens and the early health model theory of GE, both of which I have discussed in detail previously in this blog.
• What does more integrative mean in this context? For me, it means that the goal for the companies will be rapid, accurate, and profitable diagnostic procedures and testing. Neither company will be tightly bound by any one specific approach to medical diagnosis so I suspect that the boundary between in-vivo and in-vitro diagnosis will become increasingly permeable. As I have pointed out previously, molecular imaging provides a bridge between the in-vivo and the in-vitro worlds.
• The most interesting issue in my mind is whether one or both of these companies will tilt toward medical imaging rather than in-vitro testing. Such a tilt could be the result of one of the following factors, or a combination of them:
  • A long history of involvement in imaging by both companies from both an R&D and sales perspective, leading to a subtle (or not-so-subtle) bias in this direction
  • Higher profit margins from the sale of imaging equipment and services, leading to a business decision to favor medical imaging
  • Increasing commoditization of lab testing, which has been discussed here previously
  • Continuing higher profit margins for imaging studies in hospitals, leading to greater sales and higher profits in this sector
  • An accelerated level of regulation by the FDA of emerging biomarker technology, increasing the cost of IVDMIA development and inhibiting R&D efforts in this area

Lab Test Now Available to Detect Mesothelioma

A serum test for the presence of a mesothelioma called MESOMARK developed by Fujiribio Diagnostics is now available in the U.S. Fujiribio has signed an exclusive agreement with ARUP Laboratories to offer it to patients. Here is a description of the test from the Fujiribio web site:

The MESOMARK assay is a manual enzyme-linked immunosorbent assay for the quantitative measurement of Soluble Mesothelin-Related Peptides (SMRP). SMRP is a biomarker that is released into the bloodstream by mesothelioma cells. SMRP can be elevated years before an actual diagnosis of mesothelioma is made. By measuring the amount of SMRP present in the bloodstream, the MESOMARK assay will help physicians routinely monitor individuals with the greatest risk of developing mesothelioma due to asbestos exposure.

Here is a brief description of the mesothelioma:

Mesothelioma is a form of cancer that is almost always caused by previous exposure to asbestos. In this disease, malignant cells develop in the mesothelium, a protective lining that covers most of the body's internal organs. Its most common site is the pleura (outer lining of the lungs and chest cavity), but it may also occur in the peritoneum (the lining of the abdominal cavity) or the pericardium (a sac that surrounds the heart).

The Fujiribio web site contains the following warning: The MESOMARK assay is available in the United States for Humanitarian Use Only. Below is an explanation of the Humanitarian Device Exemption (HDE) copied from the FDA web site:

A Humanitarian Device Exemption (HDE) is an application that is similar to a premarket approval (PMA) application, but exempt from the effectiveness requirements of sections 514 and 515 of the act....As defined in 21 CFR 814.3(n), a Humanitarian Use Device HUD is a “medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.

Here is some data about the sensitivity and specificity of the test provided by the manufacturer:

• SMRP was significantly elevated in the serum of 37 of the 44 patients with proven mesothelioma compared to controls
• SMRP had a sensitivity of 84% for mesothelioma, and specificity of 100% compared to other pleural diseases.

As part of my research for this note, I came across The Mesothelioma Center web site  which contains some very sophisticated medical information about the lesion, including a notice of a webcast of an extrapleural pneumonectomy (Brigham and Women's Hospital broadcasts complex lung cancer surgery over the Internet), an operation that may be performed on mesothelioma patients. One mild note of caution, however. After clicking through an advertisement on the home page for legal advice relating to asbestos-induced mesothelioma, the following information is displayed:

The Mesothelioma Center is brought to you by Goldberg, Persky & White P.C., one of the first law firms in the United States to successfully take on the asbestos industry.

A Curious Aspect of the HIMSS Registration Process

Having managed continuing medical education conferences for almost 35 years, I was surprised to learn the following about the HIMSS conference in HIStalk:

[Submitted by Anonymous] With the new remote registration process, HIMSS admits to having no way to know how many people actually attended the conference. They know registrants, not attendees. They informally poll HIMSS-approved hotels, but this is not accurate. Vendors believed booth traffic was low, but conveniently can't verify it.

[Mr. HIStalk response] Excellent point - there's no real check-in other than picking up your tote bag, if you even bother to do that (how many of those do you need?)

I must admit to being very surprised by this revelation. I do understand the efficiency of the remote registration process whereby the registrant receives an identification badge by mail prior to the meeting. What I don't understand is how and why conference organizers would omit the critical on-site step of having registrants stop at a registration booth when they arrive at the meeting. This only takes a minute, if the booths are well-staffed, and provides an important tally for both the organization and the exhibitors about who actually showed up.

My guess is that their rationale on the part of the HIMSS organizers for the elimination of this step is that it is more efficient not to require a check-in but this explanation leaves me unsatisfied. As hinted to above, I think that the answer is that they really don't want to know the number who actually show up so that they can rely on the presumably larger number who have pre-registered. In the world of conferences, you always want to announce the largest number of registrants to appeal to next year's potential registrants and vendors.

However, there has got to be more going on here than this because it makes no sense to me that some individuals will pay their registration fee and then simply not show up in town. It seems more likely to me that the meeting and exhibits have become only a minor sideshow for some and that the HIMSS event provides an opportunity for vendors and potential customers to meet and transact business outside of the actual meeting venue. This could account for a high pre-conference registration but a perceived low level of traffic in the lectures and exhibit area. It is also a trend that makes the formal meeting itself increasingly superfluous.

Transformation of User Group Conferences

I received an email notice recently about the upcoming GE Healthcare User Summit that will take place on August 27 - 30, 2007, in Boston, Massachusetts. The conference is advertised as integrating the following specialty areas: Centricity business, EMR, enterprise, imaging, laboratory, perinatal, perioperative, practice management as well as diagnostic cardiology, and telemetry . The conference home page describes the Summit in the following way:

The Summit brings users from around the world to share their ideas, network, and discover best practices through real-life case studies. This year's conference brings together the collective knowledge of users from across the [various] GE Healthcare solutions...

My first inclination was to view this conference as a Centricity user group meeting. However, I read further and discovered the the fee structure for the conference was the following:

Early Customer Registration Fee: $595
Late and On Site Customer Registration Fee $895
Customer Contracted Consultant Fee: $2,100.00

These struck me has relatively a high fee structure for a user group and that some registrants might balk at paying them if the event was a pure marketing exercise. Cerner, of course, presents its own gala annually, the Cerner Health Conference, and is participating in 89 trade shows during 2007. Cerner also charges relatively high registration fees for its annual conference but, I am sure, would recoil from the idea that this event is a user group activity. I suspect that both GE and Cerner would suggest that the educational and networking value of these conferences more than justifies their cost.

So what is going on here? I will focus on GE Healthcare rather than Cerner because it now markets a broad array of hardware, software, and IVD products spanning the entire healthcare diagnostic horizon. From both an educational and marketing perspective, their conference is highly integrative and transcends specialty boundaries. Moreover and from an educational perspective, it has a powerful claim on the mind share of its customers. One of the most powerful drivers for registrants at professional conferences such as this one is to improve one's efficiency and effectiveness in the workplace. For those healthcare professionals using a wide array of GE Centricity products, such a large conference would surely have a significant claim on their highly valued time.

Note the disconnect between the title of the conference, GE Healthcare User Summit, and the fact that most of the topics areas covered as Centricity software products. Also covered, however, are diagnostic cardiology and telemetry. I suspect that it is the intention of the company to ultimately transform this conference into a much broader cross-disciplinary and cross-product diagnostic event. This may present, in time, a formidable challenge to major specialty-bounded conferences such as the AACC's annual meeting which is cross-vendor but not cross-disciplinary. The AACC conference attracts about 20,000 participants and 700 exhibitors from more than 100 countries.

IVDMIAs and Personalized Medicine

I have written a number of previous notes about IVDMIAs. More recently, I have discussed the Coalition for 21st Century Medicine, which is a lobbying organization that has been organized to oppose the regulation of IVDMIAs. I recently came across a business article that makes reference to the various companies comprising and underwriting the Coalition (See: Valley biotech interests give FDA an earful over regulations) Below is an excerpt from it:

...Target Discovery CEO Jeff Peterson says his company that utilizes protein isoforms to diagnose ovarian and prostate cancers may not be exempt from new FDA regulations imposing major new controls on genetic testing laboratories. When the FDA ...issued a draft guidance imposing major new controls on genetic testing laboratories, small biotech labs across the country were caught off guard. No one in personalized medicine -- a field dominated by small companies in Northern California and Boston -- had imagined that the agency was prepared to extend its reach into their still-arcane world. Within a couple months, biotech companies joined forces with venture capitalists, academic researchers and patient advocacy groups to create the 21st Century Medicine Coalition....Now, the deadline for discussion is over and the FDA is finalizing new regulations that, while vague, promise to provide an independent assessment of the data and labeling claims..."But when I slept on it," [said an industry representative], "I realized that the [FDA's] driving rationale is that they want to be involved in personalized medicine decisions.

When I first read this article, I was somewhat surprised that the companies that have created the Coalition for 21st Century Medicine were referred to as biotech labs and their market sector as personalized medicine. There was nary a mention in the piece about the in-vitro diagnostic industry which is where I personally would place them. My understanding of healthcare delivery presupposes a distinct diagnostic phase of care for patients followed by a treatment or therapeutic phase. With personalized medicine, however, it may sometimes be hard to distinguish where diagnosis ends and therapy begins. In other words, the two phases may be merging under personalized medicine. For example, biomarkers can potentially be used not only to diagnose a tumor but also to monitor how a tumor is responding to chemotherapy. Similarly, medical imaging, and molecular imaging in the future, can be used not only to identify the location of a tumor but also to measure whether a treated tumor is shrinking. In-situ biomarkers can be used to deliver toxic agents directly to malignant cells.

I have previously discussed the telescoping of diagnosis into treatment. One example is the cardiologist morphing into a cardiovascular medicine specialist with control over hospital-based "cath labs" for both diagnostic angiography and therapeutic stent placement. Another example is the use of portable ultrasound devices by emergency medicine specialists and even medical students in clinical settings. These examples notwithstanding, I continue to believe that there will the very high value of diagnostic specialists in medicine will continue. However, I also see the value of a merger of pathology, lab medicine, and radiology into a Department of Diagnostic Medicine.