Navigation Links
FDA draft guidance document may limit patient access to tests

WASHINGTON, DC, August 30, 2011The Association for Molecular Pathology (AMP) submitted comments to the US Food and Drug Administration on the draft guidance document titled, "Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions." AMP is very concerned that this guidance could compromise the quality of patient care by severely reducing the availability of certain reagents and laboratory developed testing services that have become the standard of care for many diseases or conditions. Specifically, if enforced in its broadest sense without sufficient accommodations for low test volume or sufficient time for manufacturers to achieve submission compliance, the draft guidance document could result in reduced availability of testing services would limit a healthcare provider's ability to manage patient care, and ultimately limit patient access to new or improved molecular tests.

"Some products used for laboratory tests are available only as research or investigational use only products," explained AMP Professional Relations Chair Dr. Elaine Lyon. "If this guidance were to be finalized, we're concerned that patients won't be able to access tests such as those for Hepatitis C genotyping, newborn screening and HLA testing," added Dr. Lyon.

AMP supports FDA clearance and approval of research use only (RUO) and investigational use only (IUO) products, especially test kits and test systems. However, to prevent disruption of patient care, accommodations should be made to ensure continued patient access to critical tests as manufacturers come into compliance and/or instances where low test volume would deter a manufacturer from submitting an application to the FDA for that product.

"While AMP appreciates the FDA concern over the use of RUO and IUO products in laboratory developed tests, the Association questions the underlying assumption that the guidance will encourage most manufacturers to seek clearance and approval for their RUO and IUO products," said Dr. Lyon. AMP members fear that instead of seeking FDA review, some manufacturers will choose to withdraw RUOs from the clinical market. This has already occurred for many analytes, from blood-borne pathogens to sexually transmitted diseases. This would then create a shortage of supplies to develop laboratory tests, resulting in a scarcity of tests, and ultimately, barriers for patients' access to medically necessary tests.

Dr. Lyon added, "Today we are asking the FDA to consider the downstream implications of the guidance on the supplies and materials for laboratory testing, and allow for circumstances where clinical laboratories can develop tests using RUO and IUO products when no other products are available."

AMP's recommendations include:

1. To avoid the disruption of patient care, carefully consider enforcement discretion or alternative regulatory pathways to address circumstances where no FDA cleared/approved products are available, particularly for those products with limited sales volume.

2. Direct enforcement requirements for 510(k) or PMA submissions toward test kits and test systems.

3. Create a consistent and clear pathway to encourage and facilitate ASR, 510(k) or PMA applications for RUO and IUO products, with a reasonable compliance timeline. The pathway must include flexibility to be responsive to rapidly evolving areas.

4. Accommodations should be made to enable certain reagents such as primer or probe mixes to be sold as ASRs. Alternatively, another regulatory pathway could be designed for products that are too complex to qualify as ASRs but are not full test kits or test systems.

5. Clearly state the scope of the guidance. Clarify which products currently labeled as RUOs and IUOs the guidance covers, e.g., test kits, instruments, software, and reagents.


Contact: Don Hunt, Lambert, Edwards & Associates
Association for Molecular Pathology

Related biology news :

1. Californias draft Bay Delta conservation plan incomplete; needs better integration to be more scientifically credible
2. EPAs draft health assessment for formaldehyde needs improvement
3. Draft sequence of Neandertal genome wins the 2010 AAAS Newcomb Cleveland Prize, supported by Affymetrix
4. UK researchers release draft sequence coverage of wheat genome
5. APA announces draft diagnostic criteria for DSM-5
6. Researchers complete draft genome sequence for cassava
7. First draft of the pig: Researchers sequence swine genome
8. Draft potato genome based on unique potato variety
9. Neural guidance gene regulates liver development
10. New guidance issued for first responders collecting suspected biothreat agents
11. Special edition journal provides new perspectives and guidance for managing white pine blister rust
Post Your Comments:
(Date:10/29/2015)... 29, 2015 Daon, a global leader in ... released a new version of its IdentityX Platform ... North America have already installed IdentityX v4.0 ... a FIDO UAF certified server component as ... activate FIDO features. These customers include some of the ...
(Date:10/29/2015)... -- Connected health pioneer, Joseph C. Kvedar , MD, ... and wellness, and the business opportunities that arise from ... of Healthy Things . Long before health and ... Kvedar, vice president, Connected Health, Partners HealthCare, was creating ... from the hospital or doctor,s office into the day-to-day ...
(Date:10/29/2015)... YORK , Oct. 29, 2015 ... technology, announced a partnership with 2XU, a global ... to deliver a smart hat with advanced bio-sensing ... and other athletes to monitor key biometrics to ... the strategic partnership, the two companies will bring together ...
Breaking Biology News(10 mins):
(Date:11/30/2015)... and MAGDEBURG, Germany , November 30, ... (ECNR) in Vienna, Austria to ... Congress of NeuroRehabilitation (ECNR) in Vienna, Austria ... NovaVision, a wholly owned subsidiary of Vycor Medical, Inc. ... of its Internet-delivered NovaVision Therapy Suite at the 3rd ...
(Date:11/28/2015)... ... November 28, 2015 , ... • Jeon Jin Bio Corp, ... and rodent control solutions , Bird Free, ... works across all sensory modalities including visual, smell, taste and touch, enabling safe, effective ...
(Date:11/26/2015)... 26, 2015 ... Accutest Research Laboratories, a leading independent ... (CRO), has formed a strategic partnership ... Temple Health for joint work on ... ) , --> ...
(Date:11/25/2015)... -- 2 nouvelles études permettent d , ... entre les souches bactériennes retrouvées dans la plaque ... . Ces recherches  ouvrent une nouvelle voie ... efficace de l,un des problèmes de santé les ...    --> 2 nouvelles études permettent d ...
Breaking Biology Technology: