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Saturday, 01/11/2014 7:54:30 AM

Saturday, January 11, 2014 7:54:30 AM

Post# of 97237

SQNM european patent out - SA article on CBMX and SQNM
A new marketing brochure has been found on the internet indicating some potential new tests:

This brochure has a couple of new carrier tests that have been branded under the Sequenom "HerediT" brand. HerediTSMA was developed by Quest Diagnostics and the others developed by Mt Sinai Genetic Testing Laboratory. See back cover of brochure for details. What makes this intriguing is that the FDA rules for LDTs require that only the lab that develops the test can process them. Both Mt Sinai and Quest have been using massARRAY for RUO for quite some time and it appears they are now ready to buy the IMPACT Dx platforms to process patient carrier screens for Spinal Muscular Atrophy, Fragile X and Ashkenazi Jewish panel. These 3 carrier screens have not been publicly announced which likely means they are awaiting FDA approval.

The brochure also references a new product branded NextView. This appears to be an amniotic fluid analysis for positive outcomes of the MaterniT21 Plus diagnostic screen. This test name has been trademarked by Sequenom though the test would be done by CombiMatrix. This is also likely going to be announced soon as the company will likely want to include it in their presentation next week. This could provide a significant increase in microarray tests done by CombiMatrix. In their last 10Q they disclose around 1,100 tests done. Sequenom has disclosed that a little over 2% of their MaterniT21 tests come back positive. On a base of 35,000 quarterly tests, that would result in roughly 700 tests for CombiMatrix. Nice uptick and likely to be announced in the next few weeks.

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