Archived OIVD News Items

2009 OIVD 510(k) Workshop Presentations Online
Source: The Office of In Vitro Diagnostic Device Evaluation and Safety and the Association of Medical Diagnostics Manufacturers (AMDM), May 8, 2009

OIVD and the Association of Medical Diagnostics Manufacturers (AMDM) co-sponsored a 510(k) Workshop that was held on April 21-22. The presentations from this workshop can now be found on AMDM's website.

Detection of 2009 H1N1 Influenza Virus by Laboratory Testing
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, May 1, 2009

OIVD has posted additional information for laboratories regarding the 2009 H1N1 influenza and can be found here. Additionally, the Center for Devices and Radiological Health has posted information on medical devices for flu diagnosis and protection which you can find here.

Revelations in In Vitro Diagnostic (IVD) Device Labeling - Proactive Prevention of Adverse Events by Informed Decision Making
Source: Medical Product Safety Network (MedSun) Newletter #35, April 2009.

Picture this: a representative from a large, reputable company has just finished training your staff in the use of their best-selling IVD device. Each technician has passed their proficiency test and has been cleared by the company to run the assay. The instrument has been installed and calibrated and all validation runs are complete. You are ready to go, right? Wait! Don’t forget to carefully read the package insert. In this MedSun article, FDA’s Office of In Vitro Diagnostics provides tips to help you ensure that any new IVD device will not be misused in your laboratory.

OIVD Conducts the Annual 510(k) Workshop on April 21-22, 2009
Source: The Office of In Vitro Diagnostic Devices at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM), January 16, 2009

The Office of In Vitro Diagnostic Devices (OIVD) at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM) will co-sponsor the OIVD’s Annual 510(k) Workshop on April 21-22, 2009 at the Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Road, N. Bethesda, Maryland. The objective of the Annual 510(k) Workshop is to foster communication between the professional, manufacturing and regulatory community. This interactive workshop provides an opportunity to hear about 510(k) submissions from the FDA people who actually review the submissions. Helpful tips and guidance from experienced industry regulatory affairs personnel will also be provided.

In an effort to encourage the industry to use the electronic 510(k) submission program (Turbo 510(k) program) OIVD has organized a half a day hands on training for the participants to complete and package for submission an electronic 510(k). To participate in this hands-on interactive training session participants must have a laptop; OIVD will provide CDs for loading the software onto the laptops.

For more information see the Agenda. To register, see Registration Information.

FDA Publishes a New Guidance Document on Assay Migration Studies for IVDs
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, January 5, 2009

This draft guidance presents a regulatory approach to gain FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a previously approved or licensed assay is migrating (i.e., transitioning) to another system for which the assay has not been previously approved or licensed. The focus of this guidance is on the study designs and performance criteria that should be fulfilled in order for a sponsor to utilize the migration study approach in support of the change. The guidance document describes information that FDA recommends sponsors include in a PMA (premarket approval application) supplement or a BLA (Biologics License Application). This guidance does not apply to immunohematology tests licensed by the Center for Biologics Evaluation and Research (CBER). This guidance can be used for 510(k) devices where the Replacement Reagent and Instrument Family Policy does not apply (e.g., nucleic acid amplification tests) and devices for which transition to a New System presents specific concerns, either because of the nature of the analyte and indications, or because of the specific technology used.

For more information see the Guidance Document.

FDA Issued a Warning Letter to the CEO of LabCorp Regarding The Illegal Marketing of The OvaSure™ Test
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration. September 29, 2008

Following the review of information obtained from Laboratory Corporation of America (LabCorp) website including a press release and a technical bulletin as well as information provided by LabCorp in a face to face meeting with the Food and Drug Administration (FDA) on September 5, 2008, FDA issued a Warning Letter to LabCorp.

In this Warning Letter the FDA informed David P. King, President and Chief Executive Officer of LabCorp that his firm was in serious violation of the Food, Drug, and Cosmetic Act involving the illegal marketing of the OvaSure™ test and asked that the violations be promptly corrected to avoid initiation of regulatory action by the FDA.

FDA Clears New CDC Test to Detect Human Influenza
Source: Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the Food and Drug Administration (FDA), September 30, 2008

The FDA cleared for marketing the new test developed by the U.S. Centers for Disease Control and Prevention (CDC) to diagnose human influenza infections and the highly pathogenic influenza A (H5N1) viruses.

The test, called the Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel), uses a molecular biology technique to detect flu virus and differentiate between seasonal and novel influenza.

For more information on rRT-PCR Flu Panel test, and statements made by HHS Secretary Mike Leavitt, and CDC Director Julie Gerberding read the FDA’s Press Release.

For more information on flu go to www.pandemicflu.gov, and www.cdc.gov

FDA invites the CEO of Lab. Corp. to discuss strategies for clinical validation of the OvaSure™ Test
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration. August 7, 2008

The Food and Drug Administration (FDA) obtained information that Laboratory Corporation of America (LabCorp) is marketing OvaSure™ for Ovarian Cancer with unclear clinical validation status.

In a letter to the President and Chief Executive Officer of LabCorp the FDA stated that the review of LabCorp’s promotional material revealed that LabCorp is offering a high risk test that has not received adequate clinical validation, and may harm the public health. In this letter the FDA invited LabCorp to discuss validation strategies undertaken by LabCorp for marketing the OvaSure™ test.

FDA Reminds manufacturers of Class II or Class III in vitro diagnostic devices, that are currently inappropriately labeled and marketed as ASRs, to comply with the law by September 15, 2008
Source: Food and Drug Administration (FDA), Center for Device and Radiological Heath (CDRH), Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), June 6, 2008

On Friday, June 6, 2008, FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Device and Radiological Heath, issued a letter to manufacturers who have a listed Analyte Specific Reagents (ASRs) with the FDA, reminding them to ensure their Class II or Class III in vitro diagnostic devices, that are currently inappropriately labeled and marketed as ASRs, comply with the law by September 15, 2008.

In this letter the FDA states that in addition to premarket submissions, it is willing to also accept pre-IDE submissions before September 15, 2008. The FDA advises that the pre-IDE include a clear plan for each device with a premarket time line for submission and a detailed outline of the intended use and studies/data that are planned for the premarket submission(s). FDA intends to work interactively with manufacturers to reach agreement on a premarket submission plan and in those cases where agreement is reached in a timely manner; the FDA intends to notify the manufacturers that the premarket submission plan is acceptable.

The FDA warns that if agreement is not reached on an acceptable plan, or if manufacturers do not pursue the agreed up on plan in good faith, then the FDA may take enforcement action with respect to the affected products.

For more information see the Reminder Letter.

Towards an Artificial Pancreas: FDA, NIH, & JDRF Workshop on July 21-22, 2008
Source: The Office of In Vitro Diagnostic Devices at the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and National Institutes of Health (NIH) and the Juvenile Diabetes Research Foundation (JDRF), April 30, 2008

The Food and Drug Administration (FDA), in collaboration with the National Institutes of Health (NIH) and the Juvenile Diabetes Research Foundation (JDRF), is holding a public workshop focused upon the state of the art in the research and development of an artificial pancreas. The workshop “Towards an Artificial Pancreas: An FDA-NIH-JDRF Workshop” will provide a public forum for discussing the progress and remaining challenges in the development of closed-loop systems designed to regulate glycemic control, as an aid in the management of diabetes mellitus. It is intended to provide stakeholders with information that will accelerate the development of an artificial pancreas.

For more information see the Workshop’s Webpage 

FDA Reminds Healthcare Professionals About Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter 
Source: Food and Drug Administration, Center for Biologics Evaluation and Research, April 17, 2008.

This notice is intended to alert physicians, nurses, medical technologists, pharmacists and other healthcare professionals, who perform glucose monitoring, of the potential for life-threatening falsely elevated glucose readings in patients who have received drug products containing maltose, galactose, icodextrin , or d-xylose, and subsequently tested using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) based glucose monitoring systems. The GDH-PQQ method of glucose determination is non-specific for glucose and in the presence of maltose, galactose, icodextrin, or d-xylose, may yield falsely elevated glucose readings.

For more details see Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product.

FDA Reminds Glucose Meter Users to Only Use Strips Recommended For Their Meter 
Source: Food and Drug Administration, office of In Vitro Diagnostic Devices, March, 8, 2008

The purpose of this notice is to remind users of blood glucose meters to read the instructions for use carefully and to only use test strips recommended for their meter by the blood glucose meter’s manufacturer. While this problem has been identified recently as occurring with a unique meter-strip configuration, FDA recognizes that similar problems can also occur if other brands and models of meters and strips are not used in proper combination.

FDA Publishes a New Guidance Document on Detection and Differentiation of Influenza Viruses
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, February 15, 2008

FDA is issuing this draft guidance to provide industry and agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) intended for the detection, or detection and differentiation, of influenza viruses. These devices are used to aid in the diagnosis of influenza infection. They include devices that detect one specific type or subtype, as well as devices that detect more than one type or subtype of influenza virus and further differentiate among them, to indicate whether the specimen contains influenza A virus versus influenza B virus, or which subtype of influenza A is present. This guidance provides detailed information on the types of studies FDA recommends to support Class I and Class I1 premarket submissions for these devices. The guidance includes a list of influenza virus strains recommended for analytical sensitivity studies, a list of microorganisms recommended for analytical specificity studies, and an example of a suggested format for presenting data from cross-reactivity studies.

This document is limited to studies intended to establish the performance characteristics of devices that detect either influenza viral antigens or influenza viral genome (protein or nucleic acid). It includes rapid detection devices and nucleic acid-based devices. It does not address detection of serological response from the host to the viral antigen, nor does it address establishing performance of non-influenza components of multi-analyte or multiplex devices.

For more information see the Guidance Document.

FDA Publishes Final Guidance Document on CLIA’ 88 Waiver Applications
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, January 30, 2008

This guidance describes recommendations for device manufacturers seeking to submit information through a CLIA waiver application to FDA to support a determination whether the device meets CLIA statutory criteria for waiver. In this document, FDA recommends an approach to demonstrating that an in vitro diagnostic device is simple and has an insignificant risk of an erroneous result. As part of demonstrating the latter, FDA recommends studies to be conducted to demonstrate the test is "accurate."

This document does not address test systems cleared or approved by FDA for over-the-counter or prescription home use since these automatically qualify for CLIA waiver. 42 U.S.C. 263a(d)(3). This guidance document also does not address use of the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)’s replacement reagent and instrument family policy for waived devices; that policy does not currently apply to CLIA waiver applications.

The recommendations in this document is based on FDA’s interpretation of the law, experience with CLIA complexity determinations, and interactions with stakeholders.

Some of the changes reflected in this document (as well as in the 2005 draft guidance document) from the earlier 2001 draft guidance document entitled “Guidance for CLIA 1988 Criteria for Waiver,” include the following:

• Greater emphasis on scientifically-based flex studies 2 and validation and/or verification studies, linked to the risk assessment for each device.
• Recognition that reference methods may not be available for every device type. (However, devices should be traceable to true reference methods of known accuracy, when such methods are available.)
• Additional emphasis on use of quality control procedures.
• Greater emphasis on intended users (which may include medical assistants, nurses or doctors, and lay people, as appropriate) during studies testing the device.
• Updated study recommendations with emphasis on use of patient specimens, in an intended use environment, over time.

FDA Joins NIH in Awareness Campaign for Hemoglobin A1c Testing
Source: FDA, January 29, 2008

FDA joins a new information campaign of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) that highlights the importance of using accurate methods to test hemoglobin A1c in people with diabetes who have sickle cell trait or other inherited forms of variant hemoglobin.

Intensive control of blood glucose reduces complications of diabetes. The hemoglobin A1c blood test (or simply the A1c test) is an essential tool in diabetes care because it shows a patient’s average level of blood glucose control in the previous 2 to 3 months. Physicians base their treatment decisions in large part on the A1c test results. Inaccurate A1c readings, whether falsely high or low, may lead to the over treatment or under treatment of diabetes.

It has become evident that some of the FDA cleared A1c assays do not accurately measure the hemoglobin A1c in African, Mediterranean, and southeast Asian patients with hemoglobin variant S (HgS), also known as sickle cell trait, and variant C (HgC), another common variant in the United States. For a list of test methods often used to measure hemoglobin A1c and whether the method is affected by either HgS or Hgb C trait go to the National Glycohemoglobin Standardization Program (NGSP) web page at the University of Missouri School of Medicine, that is working to improve and standardize the measurement of A1c in laboratories around the world.

OIVD’s Shortcuts on the Critical Path to the Market, February 19, 2008
Source: The Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), Clinical Device Group (CDG), and the Food and Drug Law Institute (FDLI), January 24, 2008

The Office of In Vitro Diagnostic Devices at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Clinical Device Group (CDG), and the Biomedical Engineering Alliance and Consortium (BEACON), will co-sponsor the IVD eConference “OIVD’s Shortcuts on the Critical Path to the Market” on February 19, 2008. The objective of the eConference is to foster communication between the professional, manufacturing and regulatory community.This eConference provides an opportunity to hear about the shortcuts OIVD is taking on the IVD’s critical path to the market.
eConference descriptions and Registration

OIVD Conducts the Annual 510(k) Workshop on April 22-23, 2008
Source: Source: The Office of In Vitro Diagnostic Devices at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM), January 15, 2008

The Office of In Vitro Diagnostic Devices (OIVD) at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM) will co-sponsor the OIVD’s Annual 510(k) Workshop on April 22-23, 2008 at the Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Road, N. Bethesda, Maryland. The objective of the Annual 510(k) Workshop is to foster communication between the professional, manufacturing and regulatory community. This interactive workshop provides an opportunity to hear about 510(k) submissions from the FDA people who actually review the submissions. Helpful tips and guidance from experienced industry regulatory affairs personnel will also be provided.

In an effort to encourage the industry to use the electronic 510(k) submission program (Turbo 510(k) program) OIVD has organized a half a day hands on training for the participants to complete and package for submission an electronic 510(k). To participate in this hands-on interactive training session participants must have a laptop; OIVD will provide CDs for loading the software onto the laptops.

For more information see the Agenda.

FDA Encourages the In Vitro Diagnostic Community to Comment on the Draft Report to the Secretary of Health and Human Services (HHS) on the Oversight of Genetic Testing
Source: Office of Biotechnology Activities, National Institutes of Health, November 2007

The Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) is seeking public comment on a Draft Report to the Secretary of Health and Human Services (HHS) on the oversight of genetic testing. FDA encourages all the stockholders to submit comments on the draft report to SACGHS by December 21, 2007. Comments received by December 21, 2007 will be considered by SACGHS in preparing its final report. Please submit comments to SACGHS by emailing them to Cathy Fomous, Ph.D.  Alternatively, comments may be mailed or faxed to:

Secretary’s Advisory Committee on Genetics, Health, and Society
Attn: Cathy Fomous, Ph.D.
NIH Office of Biotechnology Activities
6705 Rockledge Drive, Suite 700
Bethesda, MD, 20892 (20817 for non-US Postal Service mail)
Fax: 301-496-9839

In addition to submitting written comments, the FDA encourages the stakeholders to participate in a public meeting held by SACGHS on November 19-20, 2007 to provide testimony on this topic. The public meeting is being held at the Ronald Reagan Building, Washington, DC.

FDA Publishes a New Guidance Document titled IVD Device Studies - Frequently Asked Questions
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, October 25, 2007

This guidance document, written in question and answer format, is intended to assist the manufacturer, sponsor, applicant, investigator and the IVD device industry in the development of IVD studies, particularly those exempt from most of the requirements of the Investigational Device Exemptions (IDE) regulation and to provide a broad view of the regulatory framework pertaining to the development phase of IVD devices. The information in this guidance document is also pertinent to investigators who participate in IVD studies and to institutional review boards (IRB) that review and approve such studies. The document is intended to facilitate the movement of new IVD technology from the investigational stage to the marketing stage.

This guidance document outlines FDA regulations applicable to studies for investigational IVD devices, including those regulations related to human subject protection. The guidance also explains data considerations that ultimately will affect the quality of the premarket submission. This document includes a glossary, a reference list with related web addresses, and a quick-reference table.

For more information see the Guidance Document.

FDA Clears Genetic Lab Test for Warfarin Sensitivity
Source: Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the Food and Drug Administration (FDA), September 17, 2007

The FDA cleared for marketing a new genetic test that will help physicians assess whether a patient may be especially sensitive to the blood-thinning drug warfarin (Coumadin), which is used to prevent potentially fatal clots in blood vessels.

The Nanosphere test is not intended to be a stand-alone tool to determine optimum drug dosage, but should be used along with clinical evaluation and other tools, including prothrombin time (PT) and International Normalized Ratio (INR), to determine the best treatment for patients.

The Nanosphere test was cleared for use on the Verigene System, a clinical laboratory test system. Both products are manufactured by Nanosphere Inc., Northbrook, Ill.

For more information on Nanosphere test, read the FDA's Press Release.

FDA Again Clarifies the Analyte Specific Reagents (ASRs) Rule and its Requirements
Source: Guidance for Industry and FDA Staff- Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions, issued September 14, 2007

In 1997, FDA issued a rule on Analyte Specific Reagents (ASRs), which defined and classified the substances, imposed restrictions on their sale, distribution and use, and established their labeling requirements. This guidance document is intended to clarify the regulations regarding commercially distributed ASRs and the role and responsibilities of ASR manufacturers. The draft of this guidance was issued September 7, 2006. FDA received and considered more than 30 sets of comments on the draft guidance document. After taking the comments into consideration, the FDA has revised the draft document to provide clarifications as needed. This includes clarifying that FDA views ASRs as agents intended to detect a single ligand or target. This change further clarifies that oligonucleotide primer pairs and polyclonal antibodies can meet the definition of an ASR when properly marketed because they are for the identification of a single target or ligand (e.g., used to detect a single protein, a single nucleotide change, a single epitope). In addition, FDA has clarified that where manufacturers provide laboratories with information describing the use of their product in a specific test, the manufacturer's product would fall outside the definition of an ASR.

In order to assist manufacturers of Class II or III in vitro diagnostic devices that are currently being inappropriately labeled and marketed as ASRs to come into regulatory compliance, FDA intends to exercise enforcement discretion with respect to premarket approval and clearance requirements for such products for twelve months following the publication of the notice of availability of the final guidance. Manufacturers should ensure their products comply with the law by September 15, 2008.

A notice of availability has been submitted to the Federal Register.
For more information see the Guidance Document.

FDA Issues Guidance on Procedures for Handling Post-Approval Studies
Source: Office of Surveillance and Biometrics, Center for Devices and Radiological Health, the Food and Drug Administration (FDA), August 1, 2007

Evaluation of Premarket Approval Applications (PMAs) by the Center for Devices and Radiological Health (CDRH) is a multi-step process in which CDRH evaluates the sponsor’s information to reach the final decision on whether a product can be approved. To help assure the continued safety and effectiveness of an approved device, CDRH may require a post-approval study (also referred to as Condition of Approval or Post-Approval studies).

The goal of this guidance is to provide recommendations to sponsors and CDRH staff on expectations concerning format, content, and review of reports related to post-approval studies to help ensure that the studies are conducted effectively and efficiently, and in the least burdensome manner. Although some post-approval studies may involve animal or laboratory bench studies, the recommendations in this guidance focus on clinical post-approval studies. The FDA intends for these recommendations to improve post-approval studies by:

• helping the Center and sponsors ensure consistency in post-approval submissions;
• helping all stakeholders to easily and quickly identify and track post-approval studies;
• enhancing sponsor and CDRH discussions on mutually understood study objectives;
• facilitating timely discourse on study issues and challenges; and
• providing opportunities to resolve issues.

In sum, these improvements are intended to enhance information about marketed devices by ensuring that appropriate post-approval studies are efficiently initiated, conducted, completed, and reviewed.

For more information see the Guidance Document.

FDA Publishes a Revised Draft Guidance Document for In Vitro Diagnostic Multivariate Index Assays
Source: Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays issued July 26, 2007

The FDA issued a revised draft guidance document entitled “In Vitro Diagnostic Multivariate Index Assays” to address the definition and regulatory status of a class of In Vitro Diagnostic Devices referred to as In Vitro Diagnostic Multivariate Index Assays (IVDMIAs). The revised draft guidance which is issued with a 30-day comment period addresses premarket and postmarket requirements with respect to IVDMIAs. The initial draft of this guidance was issued September 7, 2006 with a 90-day comment period. The FDA then extended the comment period on the draft guidance document from 90 days to 180 days, and held a public meeting on February 8, 2007 to provide a forum for presentations and comments on the draft guidance document.

FDA has carefully considered the 60 sets of comments it has received on the initial draft guidance document and has revised the draft guidance document to provide clarifications as needed. With this revised draft guidance document, FDA seeks to identify IVDMIAs as a discrete category of device, and to clarify that, even when offered as LDTs, IVDMIAs must meet pre- and post-market device requirements under the Act and FDA regulations, including premarket review requirements in the case of most class II and III devices.

The revised draft guidance document now clarifies FDA regulatory mechanisms in general, such as how devices are classified and reviewed based on the risk of the intended use, how laboratory-developed IVDMIAs should be labeled, and how manufacturers can update and improve cleared or approved devices using existing mechanisms within the regulatory framework. These existing mechanisms enable manufacturers to bring innovative new tests to the market and ensure that they can be updated and improved as new scientific information becomes available. While this information is generally available in existing regulations, guidance documents, and on the FDA web site, the revised draft guidance provides a summary of this information with a focus on IVDMIAs in order to assist those stakeholders who are not familiar with existing FDA requirements.

A notice has been submitted to the Federal Register. The agency is accepting public comment for 30 days from the date of publication in the Federal Register. Electronic comments may be sent to Regulations.gov. Written comments may be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments must include the docket number (2006D-0347).

For more information see the Draft Guidance Document.

FDA Approved the First Molecular-Based Test to Detect Metastatic Breast Cancer
Source: Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the Food and Drug Administration (FDA), July 16, 2007

The FDA approved for marketing the first molecular-based laboratory test that determines whether breast cancer has spread (metastasized) to nearby lymph nodes. The GeneSearch BLN test, manufactured by Veridex, a Johnson & Johnson Company, of Warren, N.J., detects molecules that are abundant in breast tissue but scarce in a normal lymph node.

The presence or absence of breast cancer cells in underarm lymph nodes is a powerful predictor of whether the cancer has spread and is used to help decide appropriate therapy for a woman with metastatic breast cancer.

For more information on GeneSearch BLN test , read the FDA’s Press Release.

FDA Publishes a Guidance Document for Pharmacogenetic Tests and Genetic Tests for Heritable Markers
Source: Office of In Vitro Diagnostic Device Evaluation and Safety, June 19. 2007

This guidance document provides recommendations to sponsors and FDA reviewers in preparing and reviewing premarket approval applications (PMA) and premarket notification (510(k)) submissions for pharmacogenetic and other human genetic tests, whether testing is for single markers or for multiple markers simultaneously (multiplex tests). Array-based tests (commonly referred to as microarrays) are a subset of multiplex tests and are included in the scope of this document. The recommendations within this guidance for elements of a genetic test submission apply to pharmacogenetic (e.g., drug-metabolizing enzyme allele tests, single nucleotide polymorphism (SNP) analysis) and other types of genetic tests. Tests of gene expression and tests for non-heritable (somatic) mutations are not specifically addressed. This guidance considers nucleic acid-based analysis only, but the principles may be applied to other matrices (e.g., protein) when the purpose is to provide genetic information.

For more information see the Guidance Document and the Federal Register notices.

FDA Clears the First Quick Test for Malaria
Source: Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the Food and Drug Administration (FDA), June 4, 2007

The FDA cleared for marketing the first rapid test for malaria, a mosquito-borne disease caused by a parasite.

The Binax NOW test is manufactured by Binax Inc., a subsidiary of Inverness Medical Innovations Inc. of Scarborough, ME and is intended for laboratory use.
The Binax NOW test is significantly faster than the traditional microscopic method for detection of malaria and it is easier to use. Results are available in 15 minutes after a few drops of whole blood are placed on a dipstick. The test can differentiate between Plasmodium falciparum, and the other Plasmodium species. Results still need to be confirmed using standard microscopic evaluation.

For more information on Binax NOW test, read the FDA’s Press Release and the CDRH’s Information for Consumers.

For more information on malaria consult CDC at www.cdc.gov/malaria/

FDA Clears the First 7-Day Continuous Glucose Monitoring System
Source: Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the Food and Drug Administration (FDA), June 4, 2007

The FDA cleared for marketing the first device that measures glucose levels continuously for up to seven days in people with diabetes.
While a standard fingerstick glucose test records a person’s glucose level as a snapshot in time, the STS-7 Continuous Glucose Monitoring System (manufactured by DexCom Inc. of San Diego, Calif.), measures glucose levels every five minutes throughout a seven-day period. This additional information can be used to detect trends and track patterns in glucose levels throughout the week that wouldn’t be captured by fingerstick glucose measurements alone. However, diabetics must still rely on the fingerstick glucose test to decide whether additional insulin is needed.

For more information on STS-7 Continuous Glucose Monitoring System, read the FDA’s Press Release.

Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.
Source: Guidance for Industry and FDA Staff- Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays issued on: January 9, 2006.

This special controls guidance document was developed to support the reclassification of the herpes simplex virus types 1 and 2 (HSV 1 and 2) serological assays into class II. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.

For more information see the Guidance Document.

FDA Publishes a New Guidance Document on Reporting Results from Studies Evaluating Diagnostic Tests
Source: Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, March 13, 2007

This guidance is intended to describe some statistically appropriate practices for reporting results from different studies evaluating diagnostic tests and identify some common inappropriate practices. The recommendations in this guidance pertain to diagnostic tests where the final result is qualitative (even if the underlying measurement is quantitative). The guidance gives a special attention to the practice called discrepant resolution and its associated problems.

This document provides guidance for the submission of premarket notification [510(k)] and premarket approval (PMA) applications for diagnostic devices (tests). This guidance addresses the reporting of results from different types of studies evaluating diagnostic devices with two possible outcomes (positive or negative) in PMAs and 510(k)s. The guidance is intended for both statisticians and non-statisticians. This guidance does not address the fundamental statistical issues associated with design and monitoring of clinical studies for diagnostic devices.

For more information see the Guidance Document and the Federal Register Notice.

OIVD Conducts the Annual 510(k) Workshop on April 17-18, 2007
Source: The Office of In Vitro Diagnostic Devices at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM), February 15, 2007

The Office of In Vitro Diagnostic Devices at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM) will co-sponsor the OIVD’s Annual 510(k) Workshop on April 17-18, 2007 at the Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Road, N. Bethesda, Maryland. The objective of the Annual 510(k) Workshop is to foster communication between the professional, manufacturing and regulatory community. This interactive workshop provides an opportunity to hear about 510(k) submissions from the FDA people who actually review the submissions. Helpful tips and guidance from experienced industry regulatory affairs personnel will also be provided.

For more information see the Agenda.

To register, see Registration Information.

The Transcript of the Public Meeting on the Guidance Document for IVDMIAs are Now Available
Source: FDA, February 26, 2007

The Office of In Vitro Diagnostic evaluation and Safety (OIVD) held a public meeting on February 8, 2007, at the Hilton Washington DC/ Gaithersburg Hotel to hear presentations and comments from the stakeholders on the “Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.”

For more information see the Transcripts.

OIVD Conducts the Annual 510(k) Workshop on April 17-18, 2007
Source: The Office of In Vitro Diagnostic Devices at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM), February 15, 2007

The Office of In Vitro Diagnostic Devices at The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), and the Association of Medical Diagnostics Manufacturers (AMDM) will co-sponsor the OIVD’s Annual 510(k) Workshop on April 17-18, 2007 at the Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Road, N. Bethesda, Maryland. The objective of the Annual 510(k) Workshop is to foster communication between the professional, manufacturing and regulatory community. This interactive workshop provides an opportunity to hear about 510(k) submissions from the FDA people who actually review the submissions. Helpful tips and guidance from experienced industry regulatory affairs personnel will also be provided.

For more information see the Agenda.

To register, see Registration Information.

FDA Clears the First In Vitro Diagnostic Multivariate Index Assay (IVDMIA)
Source: Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the Food and Drug Administration (FDA), February 6, 2007

The FDA cleared for marketing MammaPrint test that determines the likelihood of breast cancer returning within five to 10 years after a woman’s initial cancer. It is the first cleared molecular test that has claims for genetic profiling for breast cancer prognosis.

The recurrence of cancer is partly dependent on the activation and suppression of certain genes located in the tumor. Prognostic tests like the MammaPrint can measure the activity of these genes, and thus help physicians understand their patients’ odds of the cancer spreading.

The MammaPrint test developed by Agendia, a laboratory located in Amsterdam, Netherlands, uses the latest in molecular technology to predict whether existing cancer will metastasize (spread to other parts of a patient’s body). The test relies on microarray analysis, a powerful tool for simultaneously studying the patterns of behavior of large numbers of genes in biological specimens.

For more information on MammaPrint test, read the FDA’s Press Release.

To find out what Dr. Steve Gutman, Director of the Office of In Vitro Diagnostic Device Evaluation and Safety told the press about the test see MedPage Today and drkoop.com.

For more information on breast cancer visit the American Cancer Society.