INSCYTE Corporation
	2 Berkeley Street, Suite 403, Toronto, Ontario, Canada M5A 2W3 Tel: 416-594-9393 Fax: 416-594-2420

CytoBase Report
Cervical Cytology Database Statistics

Technical Summary
Registered Women
Distribution of Diagnoses by Age and Severity
Reports of Invasive Carcinoma and Other Malignancies
Reports of ASCUS and AGUS
Reports of Low Grade and High Grade Lesions
Repeat Smears and Patient Linkage
Specimen Adequacy

Performance:

Hardware & Software:

The following table describes the age distribution of women in the CytoBase system as a percentage of the female population of the province of Ontario¹. In this period the system captured 8.84% of the population.

¹ Division of PreventiveOncology, OCTRF: post census estimates for 1993 Ontario population, Toronto 1996.
^a this number is less than the total number of patient records because in certain cases a valid date of birth was not submitted with a report.

The following table lists reported findings categorized by a diagnostic class (most severe finding on the report) correlated by the woman's age as at the time of the test. The age is calculated based on the woman's date of birth relative to the date of specimen collection. Reports where age could not be determined are not included in the counts.

Age	NAC	BA	ASCUS	AGUS	LGSIL	HGSIL	Inv.Ca.	Oth.Mal	Oth.Ab	Total	%
10-19	28,081	4,566	1,245	61	1,330	172			41	35,496	4.79%
20-29	149,545	22,933	6,284	621	5,479	1,318	8	8	231	186,427	25.15%
30-39	174,104	25,126	5,266	1,198	2,806	1,212	29	13	219	209,973	28.32%
40-49	120,522	18,930	3,790	1,168	1,426	479	28	12	169	146,524	19.77%
50-59	76,054	9,658	1,681	667	569	169	34	14	104	88,950	12.00%
60-69	43,970	4,744	667	263	194	101	27	19	71	50,056	6.75%
70+	20,432	2,211	912	110	81	62	29	9	50	23,896	3.22%
Total	612,814	88,168	19,845	4,088	11,885	3,513	155	75b	885c	741,322a	100.00%
%	82.65%	11.89%	2.68%	0.55%	1.60%	0.47%	0.02%	0.01%	0.12%	100.00%

^a The number of reported findings is less than the total number of reports registered because in certain cases the specimen was inadequate for cytological evaluation, and in other cases, either the patient's age could not be determined from submitted data or no findings in the above categories were reported.
^b INSCYTE will follow-up with the source laboratories for clarification of other malignancies.
^c The "other abnormal" category includes findings and/or suspicion of abnormalities that were not formally classified.

Note: No abnormal cells and benign atypia classes have been omitted from above graphical presentation for clarity.

• Invasive carcinoma accounts for 0.02% (155) of reported findings.
• Other malignancies account for 0.01% (75) of reported findings.
• Other Malignancies include sarcoma. INSCYTE will follow-up with source laboratories for clarification.

Abnormal squamous cells of undetermined significance account for 2.68% (19,845) of reported findings.

Abnormal glandular cells of undetermined significance account for 0.55% (4,088) of reported findings.

Low grade intraepithelial lesions account for 1.60% (11,885) of reported findings.

High grade intraepithelial lesions account for 0.47% (3,513) of reported findings.

As of June 30^th 1997, 87.77% of registered reports represented the first report registered on a woman, By this time CytoBase had also received 81,291 secondary (i.e. repeat) reports. Of the repeats, 84.30% contained patient identifiers that enabled exact linkage with a registered woman (Class A). Approximately 11.41% had a discrepancy in surname (Class B), and 4.29% had a discrepancy in date of birth (Class C). INSCYTE follows-up on these discrepancies with source laboratories.

Of all reports where specimen adequacy was reported (662,564), just over 2.81% of the specimens were deemed inadequate for a cytological evaluation. Almost 97.19% of the specimens were deemed satisfactory although many of these exhibited specific limitations as described on the following page.

Breakdown of specimen limitations

Reasons for specimen inadequacy

Unsatisfactory (no reason provided):		12,363	1.87%
Due to:	obscuring blood	755	0.11%
	obscuring inflammation	1,061	0.16%
	accelularity	444	0.07%
	insufficient cells	2,433	0.37%
	excessive drying artifacts	290	0.04%
	presence of endocervical cells only	708	0.11%
	other reasons	139	0.02%
	excessively thick preparation	117	0.02%
	presence of foreign material	28	0.00%
	broken slide	229	0.03%
	obscuring bacteria	56	0.01%
Total unsatisfactory specimens:		18,623	2.81%