Our cellular (lymphocyte) and genetic assays are used sequentially in
the clinic for the identification of cell cycle deficits in patients who are in
early or even presymptomatic stages of AD. Our lymphocyte test is
performed first in order to establish the presence of an AD-type G1/S
cell cycle regulatory deficit.

Our genetic tests then determine the patient’s genetic profile based on
his or her specific mutations in cyclin-dependent kinase inhibitor (CDKI)
genes associated with G1/S deficits.

Drug development applications include:
Patient selection and stratification:
• Support a diagnosis AD with our lymphocyte test (i.e.,identify G1/S
deficit) and then use our genetic tests to stratify patients according to
their specific CDKI mutations.
• Assess dementia risk in clinical trials with patients with mild cognitive
impairment (MCI) with our lymphocyte test and determine the presence
of specific CDKI mutations and risk factors for dementia to predict MCI
conversion to AD.

Understand clinical trial outcome:
• Use both of our assays to analyze clinical trial outcome based on the
presence of a G1/S deficit and particular CDKI mutations. 

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