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FYI

---------- Forwarded message ----------
From: Ramji Srinivasan <ramji@counsyl.com>
Date: Fri, Aug 1, 2014 at 10:32 AM
Subject: fda ldt guidance
To: Ramji Srinivasan <ramji@counsyl.com>
Cc: Gary Loeb <gary@counsyl.com>


Folks,

Yesterday, the FDA issued draft Framework Guidance for regulation of
Lab Developed Tests (LDTs):
www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/UCM407409.pdf
.

We have been expecting something along these lines for some time, and
is part of the reason we met with the FDA earlier this April. This
guidance is the first of a multi-step process that allows Congress to
review, then the public to comment, then the FDA to respond to
comments, culminating with final rules that have the force of law. We
do not expect final rules until Q4:15 at the earliest, and this date
could be significantly later.

What does this ultimately mean for Counsyl?

Within 6 months after the rules are final (June 2016), we may need to
register each of our products with the FDA. Additionally, in 2014 and
2015, we will develop a framework to analyze each of our tests to
determine whether we may need to seek certain FDA approvals. The
analysis for Family Prep may well be different from Inherited Cancer,
both of which could be different from future products.

What does this mean now?

(1) This is significant issue, but not an overly disruptive one. (2)
Please do not speculate too much publicly (media, etc.) on this except
to say that we share the FDA’s goal of making LDTs the best they can
be and that we look forward to continuing to work with the FDA. (3)
Stay tuned for more developments as this “draft Framework” Guidance
ultimately becomes “final regulatory” Guidance.

If you have any additional questions, Gary and our legal + regulatory
team are helping to drive this. Feel free to check in anytime if you
have specific questions.

Thanks,

Ramji Srinivasan
ramji@counsyl.com
650.714.1635
180 Kimball Way
South San Francisco, CA 9408