Diagnostic Kits/Glossary

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Analyte Specific Reagent (ASR)

Code of Federal Regulations Title 21 (21CFR809.30) states that ASRs may only be sold to: IVD manufacturers, CLIA labs capable of high-complexity testing, and organizations that use the reagents for non-clinical uses.

There are 3 classes of ASRs, I, II, and III. The analytical and performance characteristics of Class I ASRs are not established by the FDA, and for Class II and III ASRs are only established as a component of a cleared test. Because ASRs do not generally require full FDA pre-market review, they can be developed more quickly for less money. But they are not sold as complete diagnostics - instead, CLIA labs purchase ASRs to use in diagnostic tests they develop internally.

Examples of ASRs:

  • biomarkers
  • etc
  • etc


Can non-CLIA customers purchase ASRs for non-clinical use?


What is the distinction between the three classes of ASRs?

Clinical Laboratory Improvement Amendments (CLIA)

Passed by Congress in 1988, CLIA established "quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. A laboratory is defined as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health."[1]

The stringency of CLIA regulations increase with the complexity of the test being performed. Three categories have been established: waived complexity, moderate complexity, and high complexity.

The CMS implements CLIA (and receives certification and inspection fees from labs), the CDC is responsible for CLIA studies, and the FDA is responsible for test categorization.

"To enroll in the CLIA program, laboratories must first register by completing an application, pay fees, be surveyed, if applicable, and become certified."[1]

[1] http://www.cms.hhs.gov/CLIA/07_Program_Descriptions_Projects.asp
[2] http://www.fda.gov/cdrh/CLIA/

In-Vitro Diagnostic (IVD)

"Definition: In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. [21 CFR 809.3]" [1]

Regulation

"There are essentially two kinds of tests: those that are manufactured and sold in volume as kits to laboratories and those that are developed within a particular laboratory (called laboratory-developed assays). In each case, their development and entry into the market - that is, their use on patient specimens - is governed by sets of rules that ensure their accuracy and reliability.

The clinical laboratory tests that are performed using commercially manufactured kits and equipment (primarily tests done on body fluid samples like blood and urine) are subject to the regulations imposed by the U.S. Food and Drug Administration (FDA). In addition, other federal and state health agencies ensure that these laboratory tests meet stringent standards both during the manufacturing process and when they are used in the clinical laboratory." [2]


Diagnostic kit

Direct Access Testing (DAT)

"As with home testing, direct access testing (DAT) has been growing in popularity over the past few years. Currently, 34 states permit consumers to order their own lab tests - without a medical order from their health care provider. Also known as patient authorized testing, DAT is a reflection of Americans' focus on health and preventive medicine, offering the opportunity for patients to take a more active role in their own health care.

In some respects, direct access testing has been around for some time. Over-the-counter home tests are a type of DAT since they do not require a prescription and can be bought and used at the consumer’s discretion. Now, the trend has expanded to include laboratories offering clinical tests at the patient’s request. In retail centers in Colorado, Montana, Missouri, Kansas, and Utah, patients can walk into a lab and request certain tests; wellness centers offer health screens and other lab tests; and free-standing and mobile testing facilities offer screening tests to the public, such as in grocery stores and pharmacies.

Most DAT labs limit the availability of tests to simple, general health tests such as complete blood counts (CBC), cholesterol levels, throat and urine cultures, diabetes screening (blood glucose tests), chemistry panels, PSA for prostate cancer, thyroid tests, HIV antibody tests, blood typing, pregnancy tests, and urine drug screens.

Direct access testing may reduce costs for the patient by eliminating the expense of doctor’s office visits, providing vital information to patients who are concerned with a particular health problem or who may otherwise avoid testing due to inconvenience or concerns over anonymity. However, most insurance companies do not cover tests that are not ordered by a physician; therefore, you should expect to pay out-of-pocket for these services. In addition, labs providing DAT services must provide consumers with reference ranges and some assistance in interpreting the results. However, you are not operating under the guidance of your physician, who may be better able to determine what tests you really need but also what the results of those tests mean in light of your specific clinical signs, symptoms, and medical history." [1]


Direct to Consumer (DTC)

Reference Lab

"Reference labs are usually private, commercial facilities that do high volume routine and specialty testing. Most of the tests performed are referred from physician’s offices, hospitals and other health care facilities (e.g., nursing homes and other facilities). While most hospitals try to do as many tests as possible in-house, reference labs are used for specialized tests that are ordered only occasionally or that require specialized equipment.

Since reference labs are usually some distance away, you may never step into a reference lab - unless you visit one of their phlebotomy stations to have your blood drawn - although you probably have heard of them. Many employee health insurance plans require that you use a specific lab, which is often indicated on your insurance card." [1]


Background

Rosen. Diagnostic Test Service Commercialization: A Roadmap to Diagnostics in the 21st Century. (2008) pp. 47-48

OPPORTUNITY PRICING AND MARGINS ARE ATTRACTIVE

The bulk of reference lab test services cover highly commoditized routine tests. Here the margins are low because labs compete for clients based on cost per test. As lab medicine evolved with the development of personalized medicine, the complexity of testing has increase significantly.

New technologies are fueling faster growth in segments such as analysis of biopsy tissue, protein biomarkers and genetic testing. LabCorp and Quest have developed tests in these areas, but most have been developed by smaller reference labs such as Esoterix and US Pathology Labs.

Part of the growth in the new single analyte and multiplexed molecular and protein tests is related to the perception that these tests offer physicians decision making information not available with conventional tests. As such they command premium pricing. Therefore Quest and LabCorp have acquired several of the major esoteric testing companies to enhance their position in this high-growth segment.

These labs and other specialized reference labs have a clear advantage over test services offered by companies in their CLIA-registered labs. They have established distribution networks and immediate access to medical specialists. Thus the esoteric test segment is a clear winner for them. The average cost of a molecular test performed in a reference lab ranges from $10 to $50, reimbursement is usually at least $100 and the labs often charge as much as $500 for these tests.

Promotional and clinical study activities that provide scientific and economic evidence of the value of high-priced esoteic tests do not come cheap. None of the test companies that have launched in-company test services are in the black. Genomic Health’s success has been hard bought. The company has invested in researching a panel of biomarkers that has proved effective and has supported numerous clinical studies. Where Genomic Health and other companies that market test services save is in lab technologist training costs, after sales service and continuing education.

The reagent and instrumentation costs for many multiplexed esoteric and genomic tests are still high and demand is relatively low, most hospital labs would not be able to justify investment in offering these tests. Thus, it may appear that profit consideration is the driving force for test services. In effect, the most obvious route to market for complex and still esoteric tests is via collaboration with a reference lab or a CLIA-registered company lab. In this way the test becomes available to the largest number of physicians and patients.


PreMarket Approval (PMA)

[1] http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/default.htm

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