B. Profiles of 8 Leading Molecular Diagnostic Labs

ARUP Laboratories, Inc.
600 Chipeta Way
Salt Lake City, Utah 84108
Phone: 801-584-5188
Fax: 801-584-5108
Laboratory Director: Ronald L. Weiss, MD, MBA
http://www.aruplab.com
Yearly Test Volume: 550,000 samples

ARUP Laboratories, Inc., is a reference laboratory wholly owned by the University of Utah. It handles 20,000 specimens per day, totaling more than 7,000,000 specimens per year. Of those 7,000,000 specimens, about 550,000 are molecular-based diagnostic tests. They employ a total of 1,800 people, of whom about 900 are in technical areas. ARUP has a test menu of more than 2,000 tests and test combinations in the clinical laboratory testing and clinical pathology arena. Founded in 1984, ARUP Laboratories serves clients in 50 states; their clients include hospital and regional laboratories, but they do not serve private physicians’ offices.

ARUP Laboratories began performing molecular-based tests in 1995. In their first year they placed two technologists in the molecular area, which consisted of a single laboratory. They performed 1,000 molecular-based tests. Currently ARUP has four different areas that perform molecular tests employing 70 FTEs. Their non-molecular laboratories may, on occasion, perform molecular-based tests as well. Molecular testing accounts for approximately 15 percent of total revenues. The four laboratories are:

• Molecular Infectious Diseases
• Molecular Genetics
• Molecular Oncology
• Sequencing

Dr. Edward R. Ashwood, MD, Senior Vice President, Director of Laboratories and Chief Medical Officer, says all areas are still growing. “I thought Molecular Genetics was starting to level off, but it really isn’t. There are two more tests on the horizon. We have seen some of our high-volume molecular tests start to level off a bit. That’s not because the demand is down, but because some of our clients are bringing them in-house.”

This is a trend that ARUP supports. Ashwood says, “We like our clients to set up tests. If they have the volume to support doing them themselves, we support that.” He also notes that they have increased their growth every year by getting new clients, not by acquisition.

Although viral load testing for Hepatitis C and HIV are a particularly large proportion of their test volumes, there are newer infectious disease tests as well, including enterovirus and tuberculosis, with classical microbiology often being replaced by molecular techniques.

Because many states have started newborn screening projects, Ashwood notes that there has been increased demand for confirmatory tests, for example, for galactasemia.

New tests with more automation are always being brought on board. ARUP is utilizing its third generation of viral load tests and Ashwood notes they’re still changing. “We fully expect the FDA will approve a new version of the HIV viral load test this coming year, which will probably force labs to get it. It’s always improving.”

He adds that one of the most laborious aspects of molecular testing is extracting nucleic acid. There is automation for this in existence, but it’s typically scaled for pharmaceutical companies that is not appropriate in size for clinical laboratories. “That’s changing,” Ashwood says. “There’s going to be some mid-range automation that I think clinical labs are going to find very useful.”

One area of molecular diagnostics that is quite rare, but which Ashwood believes there may be growth in is sequencing—trying to determine the differences in base pair sequences in whatever relevant gene is being studied. The problem with sequencing is an abundance of information and how to interpret it. For instance, ARUP will sequence the entire cystic fibrosis (CF) gene if asked to. Ashwood says, “We find variations and then the big question is, is that variation significant enough to cause disease? Oftentimes we don’t know the answer to that question. The science isn’t far enough along to know.”

Because of the potential complexity of interpreting molecular results, ARUP employs three genetic counselors to assist physicians who need help interpreting test results. It also acts as a training ground for the University of Utah’s Genetic Counseling Program.

At A Glance

• A reference lab wholly owned by the University of Utah.
• The laboratory itself performs over 7 million tests per year.
• Of those tests, approximately 550,000 are molecular-based clinical tests.
• ARUP employs approximately 70 FTEs in its four molecular diagnostic areas, which include:
    -Molecular Infectious Diseases
    -Molecular Genetics
    -Molecular Oncology
    -Sequencing
• Molecular testing accounts for about 15 percent of total revenues.

Boulder Community Hospital
Boulder Community Reference Laboratory
1000 Alpine Avenue, Suite 111
Boulder, CO 80304
Administrative Director: Lynel Vallier
Phone: 303-440-2315
Mr. Vallier is also the hospital’s corporate compliance officer
ldvallier@bch.org
www.bch.org
Yearly Test Volume: 7,000 to 12,000 molecular-based laboratory tests.

The Boulder Community Hospital Reference Laboratory services Boulder Community Hospital and its two satellite hospitals. Between the three hospitals they offer 305 licensed beds. The laboratory is also part of the Frontline Laboratory Network (FLN), which provides laboratory testing for affiliated members throughout Colorado.

The Boulder Community Reference Laboratory has been at its current location in the Boulder Community Hospital since 1987. The laboratory overall performs approximately $1.1 million in billable procedures a year. Of those procedures, approximately 12,000 are molecular-based laboratory tests. The laboratory began offering molecular-based tests in 1998 on a limited basis. The first tests offered were for Chlamydia/Gonorrhea. They currently offer Chlamydia/Gonorrhea, HIV semi-quantitative tests, HCV (Hepatitis C Virus) semi-quantitative, and Human Papilloma Virus (HPV).

Lynel Vallier, the laboratory’s administrative director, notes that their affiliation with the Frontline Laboratory Network was one of the reasons they began offering molecular tests. “We became one of the providers of that test for the network. We had sufficient volume so it was financially feasible.”
Their growth for molecular-based tests has been steady, but not spectacular. They have no plans to increase the number and type of molecular-based tests, although their volume for their current test menu continues to increase.

Vallier notes that molecular testing is becoming simpler as the technology becomes more kit-oriented. “You don’t necessarily need dedicated rooms, although we do. We have one that’s specifically dedicated to molecular testing.” All of their tests are kit-based and are semi-automated. Their initial kit was for Chlamydia/Gonorrhea, manufactured by Abbott Laboratories, but that specific kit has since been taken off the market. Vallier says the molecular testing has proven profitable, but because they are a relatively small laboratory everything must remain kit-based in order to be cost-effective.

The laboratory has approximately 105 total FTEs. Of those, 38 are medical technologists. Only four perform molecular testing. Originally they trained more, but have found that the more technologists they rotated through the molecular testing area, the more problems they had with consistency of technique and the resulting problems with consistency of results.

At A Glance
• $1.1 million in annual laboratory billable procedures
• 105 FTEs
• 38 medical technologists/technical staff
• 4 medical technologists dedicated to molecular test procedures.
• Performs 7,000 to 12,000 molecular-based tests annually.

Boyce and Bynum Pathology Labs, PC
200 Portland
Columbia, MO 65201
Phone: 573-886-4689
Molecular Pathology Laboratory Supervisor: Patricia Zeitlow
pzeitlow@bbpllab.com
Medical Director: Dr. Michael Curry, MD, PhD
www.bbpllab.com
Yearly Test Volume: 6,000 samples

Boyce and Bynum Pathology Labs, PC (BBPL) is an independent, privately held regional reference laboratory located in Columbia, Missouri. Founded in 1964, it was created to provide technology not available to small hospital laboratories. Boyce and Bynum Pathology Professional Services Inc., a sister corporation, employs twenty pathologists who function as medical directors of various regional hospitals. BBPL is a full-service laboratory that provides services in chemistry, hematology, microbiology, immunology, molecular pathology, anatomic pathology, dermatopathology, cytology and histology that processes 2 million samples annually. Of those, in excess of 6,000 are molecular-based tests. Molecular testing is approximately 8 percent of their total revenue.

Boyce and Bynum Pathology Labs employs approximately 350 FTEs at their central and multiple patient service centers and smaller laboratories throughout the state of Missouri. Of the 350 employees, 250 work in technical areas. Four and a half (4-1/2) technologists work in molecular test areas.
Their current molecular test menu is:

• Chlamydia/Gonorrhea
• Cystic Fibrosis
• Factor V Leiden
• Prothrombin gene mutation
• Huntington’s Disease (Hfr)
• Her-2/Neu for breast cancer
• UraVysion bladder cancer testing (Abbott Laboratories)
• Human papilloma virus

Boyce and Bynum began performing molecular-based tests in 2001 with the Her-2/Neu using in situ hybridization. Growth has been significant, both in test volumes for current menu items and menu expansion. They expect to offer tests for Hepatitis C Virus (HCV) in 2006.

Boyce and Bynum has a partnership with a group of genetic counselors. If any of their clients—physicians or patients—require genetic counseling, they can refer them to the genetic counselors. They also provide a service to clinicians who may not be current on molecular technology and test interpretation.

At A Glance
• A private, independent full-service laboratory serving small hospitals in southern Missouri.
• Performs approximately 2 million tests per year.
• Of those tests, approximately 6,000 are molecular-based clinical tests.
• Boyce and Bynum has approximately 350 FTEs with only 4.5 FTEs working on molecular-based testing.
    - Molecular testing accounts for about 8 percent of total revenues.

City of Hope National Medical Center
Clinical Molecular Diagnostic Laboratory
1500 E. Duarte Road
Fox South, 2nd Floor
Duarte, CA 91010
Phone: 888-826-4362
Fax: 626-301-8142
Laboratory Director: Dr. Steven Sommer, MD, PhD
Sommeradmin@COH.org
www.cityofhope.org/cmdl/
Yearly Test Volume: 3,000 samples

The City of Hope National Medical Center is one of 39 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers in the United States. The Clinical Molecular Diagnostic Laboratory (CMDL) provides molecular genetic testing with what they call an “epidiomic model: expert genotype to phenotype analysis in the context of a molecular epidemiology collaborative group and a methodology development group.” The Clinical Molecular Diagnostic Laboratory operates independently of the general reference laboratory.

The CMDL performs tests on approximately 3,000 samples annually. The laboratory’s yearly revenues are $3 million to $5 million and growing. They offer tests on between 30 and 40 genes for about 50 different diseases including Ataxia Telangiectasia Mutated (ATM), Breast Cancer, Prostate cancer and Li-Fraumeni/Li-Fraumeni-like Syndrome (CHEK2), Charcot-Marie-Tooth Disorder Type 2 (Lamin A/C) and numerous others. Dr. Steven Sommer, MD, PhD, Laboratory Director, says, “Most of our tests are comprehensive analyses. We often have more than one test per gene; typically one test reflexes to another if a mutation is not found.”

The CMDL has three broad areas of specialization or concentration. They are:
• Cancer genetics
• Neuropsychiatric genetics
• Selected inborn errors of metabolism (for instance: Cystic Fibrosis, muscular dystrophy, hemophilia and Marfan syndrome).

The CMDL was created in 1998 and initially employed three people. It currently employs 12 technologists, two genetic counselors, four mutation experts who are either MDs or PhDs and board eligible or board certified by the American College of Medical Genetics (ACMG), and one bioinformatics specialist.

[A total of 19 FTEs].

The laboratory continues to have high growth, both in the volume of the current test menu and by the addition of new tests. The laboratory has had a 6-fold increase in test volume in the last two years.

Sommer says, “We perform not only the clinical tests, but we perform research for and on many of the genes, so we specialize in providing the ultimate in what we call phenotype/genotype analysis. We have four co-directors in other laboratories, and they’re each experts in their fields. I chair the Department of Molecular Diagnostics and the Department of Molecular Genetics, which is a research department. The initial tests the clinical laboratory offered were ones in genes that I had a long-term research presence in.”

At A Glance
• A molecular diagnostic laboratory in support of a NCI-designated Comprehensive Cancer Center.
• The laboratory performs approximately 3,000 high-complexity molecular tests
annually.
• The laboratory has seen a 6-fold increase in volume in the last two years.
• The laboratory employs 12 technologists, 2 genetic counselors, 4 mutation experts who are either MDs or PhDs and board eligible or board certified by the American College of Medical Genetics (ACMG), and 1 bioinformatics specialist.
     - The laboratory’s annual revenues are approximately $3 to $5 million.

Laboratory Corporation of America (LabCorp)
Corporation Headquarters
430 South Spring Street
Burlington, NC 27215
336-584-5171
Chief Executive Officer: Thomas P. MacMahon
Pamela Sherry, Senior Vice President
Corporate Communications
Phone: 336-436-4855
Fax: 336-436-1205
sherryp@labcorp.com
www.labcorp.com
Yearly Test Volume: 6,700,000 samples

Laboratory Corporation of America (LabCorp) is a publicly-held corporation and one of the world’s largest clinical laboratories. They test more than 360,000 samples daily—about 1.1 million tests—for over 220,000 clients across the United States. In 2005 their revenues were $3.3 billion. They employ approximately 24,000 people.

LabCorp began molecular-based testing in 1990. At that time they had a dedicated facility in Research Triangle Park, NC that employed 20 to 30 people. Because of the way molecular-based tests have infiltrated so many different areas of LabCorp and its decentralization, there is no way to indicate how many employees are involved in molecular testing. Their initial work was in infectious disease testing, as well as early work in genetics, oncology and identity testing. There are four main areas in which they see continued high growth. They are:

• Infectious Disease. This has always been the strongest area of growth for molecular testing for LabCorp and for molecular testing in general, but in the mid-1990s it rapidly expanded due to the almost simultaneous FDA approval of HIV viral load testing and the introduction of early HIV drugs. Dr. Myla Lai-Goldman, MD, Executive Vice President and Chief Scientific Officer and Medical Director, says, “Infectious disease remains a very important area and our test menus are very long and very broad and are very likely to continue to grow as molecular methods supplant some of the more traditional microbiology techniques.”

• Genetics. This area grew strongly in 2001 when the American College of Obstetricians and Gynecologists (ACOG) changed their guidelines and recommended that Caucasian couples contemplating pregnancy should be tested for cystic fibrosis.

• Cancer. LabCorp continues to see growth of molecular testing in this area. Lai-Goldman says, ”We now see significant growth and emphasis on broadening the menu for molecular oncology, both in sold tumors and liquid tumors.”

• Human Identity. LabCorp has a strong interest in human identity testing, including forensic testing and paternity testing. Their laboratory has been involved in identity testing of soldiers’ remains since Operation Desert Storm, the first Iraq War (1990). Dr. Marcia Eisenberg, PhD., Vice President and Senior Director of Research & Development, is also the founder of the LabCorp Forensic Identity laboratory. She says, “As part of our molecular testing we also have an identity paternity laboratory, which we believe is probably the largest paternity laboratory in the world.”

LabCorp also is actively utilizing microarray technology, specifically CGH comparative genomic hybridization for developmental delay. They are also evaluating several new microarrays for leukemia testing.

LabCorp has had a significant increase in both test volumes and revenue in their molecular testing areas.

        

Molecular Testing Revenues and Percentage of Total LabCorp Revenues

Although much of LabCorp’s molecular-based tests are kit-based, Lai-Goldman notes that they still perform a significant number of home brew or in-house developed assays. “The reality is there are very few kits in the molecular world. The majority of genetic tests are done using in-house developed tests. I do see that there’s a continuation of production of kits, but with the hundreds of tests that clinicians use every day, I don’t see that completely changing. In the world of genetics we have to keep in mind that many of the assays we have are not for common disorders or very high-volume disorders. We see diagnostic vendors particularly focused on the high-volume tests, and clinicians’ needs are much broader than that. I envision that there will always be a need for in-house developed assays.”

LabCorp has expanded their molecular capabilities since 2001 through several major acquisitions. They include:

• ViroMed Inc. (Minneapolis, MN)
• Dianon Systems, Inc. (Stratford, CT)
• Esoterix, Inc, (Austin, TX ) which includes Cytometry Associates, Colorado
Coagulation Associates and Endocrine Sciences.
• US LABS (Irvine, CA)

LabCorp also expands their molecular testing capabilities via partnerships with companies like EXACT Sciences (Marlborough, MA). Their partnership with EXACT Sciences has led to the launch of a test called PreGen-Plus, a screen for colon cancer.
LabCorp is also introducing molecular testing for flu, including avian flu, and an advanced HIV screening program for acute HIV, which can detect recently-infected HIV patients.

At A Glance

• LabCorp is a publicly-held corporation with $3.3 billion in annual revenues,
performing 1.1 million tests on 360,000 samples daily.
• They currently employ 24,000 people.
• LabCorp has four broad areas of molecular-based tests. They are:
    -Infectious disease
    -Genetics
    -Cancer
    -Human identity testing
• In 2005, LabCorp earned $505.2 million in molecular-based test revenue, accounting for 15.2% of total annual revenue.
• In 2005, LabCorp performed 6,700,000 molecular-based tests out of 92 million total tests.

Louisiana State University Health Sciences Center
Department of Pathology/Molecular Pathology
1501 Kings Highway
Room C2-26
Shreveport, LA 71130-3932
Phone: 318-675-5871
Fax: 318-675-8395
Laboratory Director: Mary Lowery Nordberg, PhD
mlower@lsuhsc.edu
www.lsuhsc.org
Yearly Test Volume: 3,000 samples

The Louisiana State University Health Sciences Center Molecular Pathology Laboratory supports the university-based health center and offers outreach reference services. They are affiliated with the university’s Pathology Department, but work within the Cancer Center. Founded in 1998 to provide a clinical focus for molecular diagnostics that at that time were primarily covered by scattered hybrid research laboratories, the laboratory offers traditional cytogenetics, molecular cytogenetics and molecular pathology.

The Molecular Pathology Laboratory processes approximately 3,000 samples per year. When it started offering tests in 1999, they handled fewer than 500 samples and had two technologists and the laboratory director. Now they employ 18 FTEs. In fiscal year 2004-2005, the laboratory’s revenues were over $1,500,000. At the beginning of 2006 they had already exceeded $2 million. Because the laboratory offers both molecular and cytogenetic testing, it’s difficult to break down revenue, but Laboratory Director Dr. Mary Lowery Nordberg, PhD, estimates that 60 to 70 percent of revenues are made up of molecular-based tests. In addition, approximately 60 percent of the laboratory’s work comes from outside the institution.

The laboratory does not offer molecular-based infectious disease testing, which is handled by a separate laboratory in the Pathology Department. In terms of molecular-based tests, slightly over half of their test menu focuses on cancer diagnostics (hematopathology), with inherited mutations taking up the rest. Their test menu includes:
• Hypercoagulable syndromes such as Factor V(Leiden), prothrombin 20210, MTHFR
• Cystic fibrosis
• B-and T-cell clonality in lymphoproliferative syndromes
• Inherited abnormalities in iron overload disorders, such as hereditary hemochromatosis
• Monitoring molecularly targeted therapies, such as t(9:22) BCR/ABL post-Gleevec

When the laboratory began operations, their primary test was the breast cancer HER-2/neu test. Nordberg says, “We’re a large lymphoma/leukemia/breast cancer center. We weren’t even doing HER-2/neu when I came here in 1998. We built the hematopathology tests like BRC1 and BRC-ABL as the first wave of tests. The B-cell clonality is our biggest test volume.”

In addition to PCR, ASRs and test kits, the laboratory also utilizes a CGH microarray-based test. Nordberg notes they are seeing huge increases in test volumes for the existing test menu, as well as increases for new test offerings. She also notes that new guidelines for baseline values for tests like BCR-ABL increase their workload. “Automation is attractive, always. We’re not a high throughput laboratory, but we’re at that threshold. Extractions are very difficult to do by hand and we’re looking for automation for that, and we’re looking for multi-capillary instruments for capillary gel electrophoresis.”

Nordberg also notes that there are two major issues facing a molecular laboratory. “If molecular is growing so fast, what is limiting it? How do we help it instead? How do you advocate molecular? Nobody doubts that molecular is the future, but we’re limited in a lot of ways by Medicare and CMS-type restrictions on testing.”

The second restriction is personnel. “For example, cytopathology has a cap on how many Pap smears a cytotechnologist can read. We’ve been having this issue in cytogenetics for years. How many tests can they perform before you need more people? We need to let everybody know that molecular diagnostics is not this weird, ancillary part of laboratory medicine anymore. We’re talking about frontline testing for a lot of diseases.”

At A Glance

• A support laboratory and resource laboratory associated with Louisiana State University Health Sciences Center at Shreveport.
• The laboratory offers molecular diagnostics, molecular cytogenetics and traditional cytogenetics.
• Receives approximately 3,000 samples annually.
     - Currently employs 18 FTEs and has annual revenues exceeding $2 million.

Maine Medical Center
NorDx Laboratory
102 Campus Drive
Scarborough, ME 04074
Phone: 207-885-7800
President: Stan Schofield
Laboratory Director: Gene Putz, PhD
Molecular Pathology Director: Robert Christman, MD
www.mmc.org
Yearly Test Volume: 29,000 samples

NorDx Laboratory is a private, non-profit laboratory owned by the MaineHealth health system, an integrated delivery network of hospitals, physician practices and long-term care facilities serving southern Maine. NorDx is a full-service laboratory processing approximately 23 million samples annually and employing 376 FTEs. Of those 23 million samples, approximately 29,000 are for molecular-based tests. About 20,000 of the molecular tests are for sexually transmitted diseases (STDs) and the rest are for non-STD molecular-based tests. Of the 376 FTEs, approximately 100 are in technical areas—medical technologists and laboratory technicians. Three medical technologists work in the Molecular Pathology area; one medical technologist works in the microbiology laboratory on molecular-based tests. They share a supervisor and a PhD-level staff member.

Gross revenues for the regional laboratory are approximately $36 million. The gross revenue from molecular-based tests is $995,503.

Stan Schofield, President of NorDx, notes that half of their business is with four hospitals for capitated services. That is to say, the hospitals pay NorDx approximately $22 million for testing performed, then bill patients and third-party payers independently. “We have a kind of interesting financial model here that can make it tough to do comparison. How big are we? If it’s gross dollars that are billed for services—even though I don’t bill for them—we’re a $110 million organization. If it’s straight things I can bill for on outreach, well, that’s not a good number. What’s my cost structure? About $32 million.”

The majority of their molecular testing utilizes analyte-specific reagents (ASRs) or major brand kits. Schofield notes that they do not perform home brews, although there is a small percentage of tests which are ASR-based that have been modified.

NorDx began offering molecular-based testing in 1999/2000 with STD tests. They had one technologist working molecular at that time. They added cystic fibrosis, FISH, Hepatitis C Virus (HCV), HIV, and HPV in 2001 and 2002. Their largest area of growth is in STDs. Schofield calls growth of existing tests “organic growth” and says it is about 6 percent annually. Adding new tests skews the average upward.

The NorDx test menu is fairly straightforward, with tests for Factor V(Leiden), Prothrombin gene mutation, hereditary hemochromatosis, ApoE (for cardiac, not Alzheimer’s disease), lipoprotein lipase and cystic fibrosis (CF).

Under their cancer diagnostics areas they offer HER-2/neu, bladder cancer screening, BCR-ABL, p53, MSI (microsatellite instability) and human papillomavirus (HPV). They planned to bring on cytomegalovirus (CMV), herpes simplex, and BK (virus) for kidney transplant studies by the end of the summer 2006. They are also looking at ZAP-70 for colon cancer, CD56, CD57 and p16.

Schofield believes the biggest problem currently facing molecular diagnostics is poor reimbursement. “I think we’re well behind the curve for reimbursement given the complexity of the testing and medical value. It’s determined by fiscal intermediaries—there are 58 around the country. Their medical review boards and medical appropriateness and standard of care boards determine reimbursement, but it almost has to be Medicare-approved before anybody else will touch it these days. They tag it investigational research or not-standard-of-care or experimental so they don’t have to pay for it. It’s hugely disproportionate.”

At A Glance

• NorDx Laboratory is a private, nonprofit laboratory owned by the MaineHealth health system, which services southern Maine.
• NorDx processes approximately 23 million samples annually, of which about 29,000 are for molecular-based tests.
• NorDx’s gross annual revenue is about $36 million, with molecular-based tests accounting for $995,503 in 2005.
• NorDx offers molecular-based tests for infectious disease, cancer and inherited disorders.
• They employ a total of 376 FTEs. Approximately 100 of those FTEs are technical personnel; four technologists, one supervisor and one PhD work in the molecular areas.
     - “Organic growth” of molecular-based tests is about 6 percent annually.

William Beaumont Hospital
Molecular Pathology Laboratory
3601 West Thirteen Mile Road
Royal Oak, MI 48073
Phone: 248-551-0073
Laboratory Director: Dr. Domnita Crisan, MD, PhD
www.beaumont.edu
Yearly Test Volume: 49,500 samples

The William Beaumont Hospital Molecular Pathology Laboratory supports two hospitals located in the Detroit, Michigan metropolitan area and also offers an outreach program with their reference laboratory. The William Beaumont facility in Royal Oak is a Level I trauma center with 1,061 beds. The hospital has a clinical pathology department which is separate from the surgical pathology department; the Molecular Pathology Laboratory is a part of the clinical pathology department.

The Molecular Pathology Laboratory offers over 25 tests in five general areas. Those areas are:
• Inherited disorders. These include hereditary hemochromatosis, an extended cystic fibrosis panel and an extended Ashkenazi Jewish panel as well as other inherited disorders.
• Genetic Risk Factors for cardiovascular disease and stroke. This includes ApoE phenotyping, but it is not performed for Alzheimer’s screening due to patent conflicts.
• Infectious Diseases. The laboratory’s highest volume area, it includes tests for Chlamydia/Gonorrhea, Human Papilloma Virus (HPV), Hepatitis B and C, HIV and others.
• Molecular Hematology. This includes BCR/ABL gene rearrangements. This is an area where they added tests in 2006.
• Pharmacogenomics. The laboratory provides gene-based tests for Warfarin resistance.

The Molecular Pathology Laboratory opened in 1991 with two medical technologists. They currently employ six full-time technologists, two part-time technologists and a supervisor. The laboratory’s growth rate from 2003 to 2004 was 18%. From 2004 to 2005 it was 9%. Yearly operating revenue in the Molecular Pathology Laboratory in 2005 was $2.8 million. Dr. Domnita Crisan, MD, PhD, the Laboratory Director, notes that it appears to be slowing on a percentage basis, but, “if you look at the number of tests, it’s a hefty increase each year, a few thousand each year.”

The highest volumes are in infectious disease testing, the majority through their outreach/reference laboratory, which services primarily the southeast Michigan region. Although volumes for currently offered tests increase regularly, they also continue to expand and offer new tests. Crisan notes that they make a “pretty fast transition from research to clinical testing in some areas, but most of the growth is for infectious disease tests that were previously offered.”

Although not unique, the Beaumont Hospital Molecular Pathology Laboratory is unusual in that all of the molecular tests are offered in a centralized laboratory. Because many molecular tests are replacements for specific laboratory tests, individual laboratories often offer some form of molecular tests, for example, a microbiology laboratory offering molecular-based infectious disease tests, a genetics laboratory offering molecular-based inherited disorders tests, etc. This has led some observers to predict that hospitals and laboratories will eventually organize their laboratories around various technical platforms rather than in the traditional manner of separating laboratories by type of specimen or overarching type, i.e., microbiology versus genetic versus hematology. Dr. Crisan says, “I think it’s unusual for a large hospital to have the whole molecular diagnostic testing centralized in one place. In the academic enters I know, there is a separate laboratory for molecular diagnosis of infectious diseases and molecular genetics, but here it’s just one laboratory.”

At A Glance

• A molecular pathology laboratory in support of two major hospitals with an outreach program.
• The Molecular Pathology Laboratory offers tests in five major areas, which are:
    -Inherited Disorders
    -Genetic Risk Factors for cardiovascular disease and stroke
    -Infectious Diseases
    -Molecular Hematology
    -Pharmacogenomics
• The Molecular Pathology Laboratory showed an 18% growth from 2003 to 2004 and a 9% growth from 2004 to 2005.
• They currently employ 6 full-time technologists, 2 part-time technologists and a supervisor.
     - Yearly operating revenue in the Molecular Pathology Laboratory in 2005 was $2.8 million.