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Abbott Molecular Inc.

1300 E Touhy Ave

Des Plaines, IL 60018

August 15, 2010

2010 AUG Ii A 9 : 31

Division of Dockets Management (HFA305)

Food & Drug Administration
5630 Fishers Land, Room 1061,
Rockville, MD 20852

RE: Docket No. FDA2010-N-0274

Abbott Molecular welcomes the current efforts underway by FDA to improve the
regulatory oversight process for diagnostic tests, including Laboratory Developed
Tests (LDT's). The least burdensome approach should be applied equitably by the
Agency across all laboratory diagnostic products to assure that new technologies
are available to serve public health and patient safety.

We respectfully submit the following comments for consideration:

• The Agency should consider whether the current FDA requirements for IVDs
limits the number of tests being submitted and receiving the benefit of FDA
review, which results in the use of many tests in the market that have received
no level of review from FDA. The Agency should evaluate from a holistic
perspective whether this protects and promotes public health and is best for
patient care. Related to this point, the Agency should consider why there are
not more IVD approved tests, as the answers to this question may help guide
the Agency and industry to determine solutions that do not stifle innovation and
ensure optimizing patient care. Is the current system simply too complicated,
uncertain and difficult to enable a significantly increased number of tests to be
made available for patient care in a safe and effective manner?.

• IVD Tests are routinely introduced, if at all, in the U.S. two or more years after
other markets like Europe. Due to medical need for these innovative products,
the result in the U.S. is implementation of lab developed tests, use of ASR's,
RUO kits or reagents, and off-label usage. The public health impact should be
examined when there are delays of IVD products and a dichotomy of a few
highly regulated tests on one side and many minimally regulated tests on the
other. An example of this is HCV viral load, where stringent requirements
meant only one FDA approved test was available for several years, and
because of medical necessity it became used almost exclusively off-label.

• Many tests that can provide important medical information for patient care
simply cannot sustain the sort of resource investment currently required for IVD
approval. This discourages and limits their availability. Possible solutions are
streamlined pathways (for all classes of products), better defined exemptions
for rarer diseases, and alternatives to encourage submissions as IVD devices.

A Promia..for Life
• Because current requirements are often prohibitive, many tests are only
offered as LDT's. Often these tests use kits or components labeled as "RUO".
Due to the medical need for these LDT's, there is a growing use of the "RUO"
designation in the clinical laboratory setting.

• The Agency promotes science and innovation in solving public health needs,
and therefore should take a measured approach to ensure that the pace of
innovation for laboratory products is not impacted. The Agency should
examine for example, what impact implementation of the ASR guidance has
had on innovation and accessibility of products to address un-met medical

• The regulations and the interpretation of the regulations must be flexible

enough to keep in pace with science and innovation. Specifically, for

a. The Companion Diagnostic (CDx) IVD approval process is

ambiguous and difficult. This arduous process is in part responsible
for the fact that most CDx's today are LDT's with no FDA oversight.
There must be a convergence of requirements that help facilitate
Agency oversight of such tests while ensuring that patients get the
tests that they need.
b. There are many technologies capable of highly multiplexed tests.
Current regulations require validation of each analyte claimed. This
results in companies having to sacrifice multiplexing capabilities
due to difficulty in procuring specimens or simply the cost of the
larger multiplexing being too high. An economically viable solution
must be found for these technologies to allow them to be brought to
market as IVD's.
c. These are technologies today that can identify previously unknown
organisms (e.g. Plex-ID). The current regulatory pathways make it
virtually impossible for such a capability to be approved.

• One approach which should be strongly considered is a pathway for approval

of analytical claims only which would not require submission of patient
outcomes data. This would enable approval and use of tests for analytical
purposes, with final diagnosis based on other IVD approved tests or other
• We support a risk-based approach to addressing oversight of LDT's. It is
important, however, that once the risk-benefit classifications are established,
that the same review requirements be applied to all tests whether LDT's or
traditional kits. The ambiguity in the current regulations should be significantly
reduced and enforcement should be consistently applied. If the agency
decides to allow some LDT's to exist based on risk-benefit classification, then
the definition of what constitutes a Lab Developed Test should be clarified
along with how the risks categories are established.
• Finally, the "bar is continually being raised" for quality and regulatory
compliance for 510k and PMA approved products. It is important that
manufacturers of LDTs and IVDs should have to adhere to similar
requirements for pre- and post-market/product life-cycle compliance, based on
their risk-benefit profiles.

Abbott Molecular submits these observations as both a manufacturer and a

service lab. Currently, in our service lab it is our intention to only offer FDA
approved products due to ambiguities in the regulations. At present both the
manufacturer and service lab providers are vertically integrating: Larger service
labs have acquired or built manufacturing capability, while several manufacturers
offer products through their own service labs or have acquired service labs. We
view the current initiative as an opportunity to reduce the ambiguity in the
implementation of the regulations, improve the IVD process, speed up innovation
and ultimately improve patient care. We welcome any opportunity to work with the
Agency in this initiative.


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