|
b)
Fluorescence In-Situ Hybridization (FISH) testing, which analyzes
abnormalities at the chromosomal and gene
levels;
|
|
c)
flow cytometry testing, which analyzes gene expression of specific
markers
inside cells and on cell surfaces;
and
|
|
d)
molecular testing which involves analysis of DNA and RNA to diagnose
and
predict the clinical significance of various genetic sequence
disorders.
|
Attributes
|
Clinical
|
Anatomic
Pathology
|
Genetic/Molecular
|
Testing
Performed On
Testing
Volume
Physician
Involvement
Malpractice
Ins. Required
Other
Professionals Req.
Level
of Automation
Diagnostic
in Nature
Types
of Diseases Tested
Typical
per Price/Test
Estimated
Size of Market
Estimated
Annual Growth Rate
|
Blood,
Urine
High
Low
Low
None
High
Usually
Not
Many
Possible
$5
- $35/Test
$25
- $30 Billion
4%
-5%
|
Tissue/Cells
Low
High
- Pathologist
High
None
Low-Moderate
Yes
Primarily
to Rule out Cancer
$25
- $500/Test
$10
- $12 Billion
6%
– 7%
|
Chromosomes/Genes/DNA
Low
Low
- Medium
Low
Cyto/Molecular
geneticist
Moderate
Yes
Rapidly
Growing
$200
- $1,000/Test
$4
- $5 Billion (2)
25+%
|
Established
Competitors
|
Quest
Diagnostics
LabCorp
Bio
Reference Labs
DSI
Laboratories
Hospital
Labs
Regional
Labs
|
Quest
Diagnostics
LabCorp
Genzyme
Genetics
Ameripath
Local
Pathologists
|
Genzyme
Genetics
Quest
Diagnostics
LabCorp
Major
Universities
|
FY
2006
|
FY
2005
|
%
Inc (Dec)
|
||||||||||
Customer
Requisitions Rec’d (Cases)
|
9,563
|
2,982
|
220.7 | % | ||||||||
Number
of Tests Performed
|
12,838
|
4,082
|
214.5 | % | ||||||||
Average
Number of Tests/Requisition
|
1.34
|
1.37
|
(2.1 | %) | ||||||||
Total
Testing Revenue
|
$ |
6,475,996
|
$ |
1,885,324
|
243.5 | % | ||||||
Average
Revenue/Requisition
|
$ |
677.19
|
$ |
632.23
|
7.1 | % | ||||||
Average
Revenue/Test
|
$ |
504.44
|
$ |
461.86
|
9.2 | % |
•
|
pricing
differences between our fee schedules and the reimbursement rates
of
the payers;
|
ITEM
3.
|
LEGAL
PROCEEDINGS
|
ITEM
5.
|
MARKET
FOR THE COMPANY’S COMMON EQUITY AND RELATED STOCKHOLDER
MATTERS
|
QUARTER
|
HIGH
BID
|
LOW
BID
|
||||||
4th
Quarter
2006
|
$ |
2.05
|
$ |
0.94
|
||||
3rd
Quarter
2006
|
$ |
1.25
|
$ |
0.60
|
||||
2nd
Quarter
2006
|
$ |
0.78
|
$ |
0.45
|
||||
1st
Quarter
2006
|
$ |
0.72
|
$ |
0.12
|
||||
4th
Quarter
2005
|
$ |
0.35
|
$ |
0.18
|
||||
3rd
Quarter
2005
|
$ |
0.59
|
$ |
0.24
|
||||
2nd
Quarter
2005
|
$ |
0.60
|
$ |
0.26
|
||||
1st
Quarter
2005
|
$ |
0.70
|
$ |
0.25
|
Plan
Category
|
Number
of securities to be issued upon exercise of outstanding options,
warrants
and rights
|
Weighted
average exercise price of outstanding options, warrants and
rights
|
Number
of securities remaining available for future
issuance
|
Equity
compensation plans approved by security holders
|
2,116,667
|
$0.43
|
1,703,223
|
Equity
compensation plans not approved by security holders
|
N/A
|
N/A
|
N/A
|
Total
|
2,116,667
|
$0.43
|
1,703,223
|
ITEM
6.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OR PLAN OF
OPERATION
|
|
·
|
Revenue
Recognition
|
|
·
|
Accounts
Receivable
|
Days
Outstanding
|
2006
|
%
2006
|
2005
|
%
2005
|
||||||||||||||
1-30
|
$ |
573,096
|
36.3 | % | $ |
246,457
|
43.1 | % | ||||||||||
31-60
|
541,334
|
34.3 | % |
167,170
|
29.2 | % | ||||||||||||
61-90
|
212,102
|
13.4 | % |
61,828
|
10.8 | % | ||||||||||||
91-120
|
126,284
|
8.0 | % |
51,296
|
9.0 | % | ||||||||||||
>120
|
125,672
|
8.0 | % |
62,155
|
7.9 | % |
|
·
|
Increase of approximately 136% in supply costs;
and
|
|
·
|
Increase of approximately 183% in postage and delivery
costs
|
Request
|
Completion
|
Shares
of
|
Gross
|
|
Cornell
|
Escrow
|
Net
|
||||||||||||||||||
Date
|
Date
|
Common
Stock
|
Proceeds
|
|
Fee
|
Fee
|
Proceeds
|
ASP(1)
|
|||||||||||||||||
8/29/2005
|
9/8/2005
|
63,776
|
$ |
25,000
|
$ |
1,250
|
$ |
500
|
$ |
23,250
|
|||||||||||||||
12/10/2005
|
12/18/2005
|
241,779
|
50,000
|
2,500
|
500
|
47,000
|
|||||||||||||||||||
Subtotal
–
2005
|
305,555
|
$ |
75,000
|
$ |
3,750
|
$ |
1,000
|
$ |
70,250
|
$ |
0.25
|
||||||||||||||
7/19/2006
|
7/28/2006
|
83,491
|
53,000
|
2,500
|
500
|
50,000
|
|||||||||||||||||||
8/8/2006
|
8/16/2006
|
279,486
|
250,000
|
12,500
|
500
|
237,000
|
|||||||||||||||||||
10/18/2006
|
10/23/2006
|
167,842
|
200,000
|
10,000
|
500
|
189,500
|
|||||||||||||||||||
Subtotal
–
2006
|
530,819
|
$ |
503,000
|
$ |
25,000
|
$ |
1,500
|
$ |
476,500
|
$ |
0.95
|
||||||||||||||
12/29/2006
|
1/10/2007
|
98,522
|
150,000
|
7,500
|
500
|
142,000
|
|||||||||||||||||||
1/16/2007
|
1/24/2007
|
100,053
|
150,000
|
7,500
|
500
|
142,000
|
|||||||||||||||||||
2/1/2007
|
2/12/2007
|
65,902
|
100,000
|
5,000
|
500
|
94,500
|
|||||||||||||||||||
2/19/2007
|
2/28/2007
|
166,611
|
250,000
|
12,500
|
500
|
237,000
|
|||||||||||||||||||
2/28/2007
|
3/7/2007
|
180,963
|
250,000
|
12,500
|
500
|
237,000
|
|||||||||||||||||||
Subtotal
–
2007
YTD
|
612,051
|
$ |
900,000
|
$ |
45,000
|
$ |
2,500
|
$ |
852,500
|
$ |
1.47
|
||||||||||||||
Total Since
Inception
|
1,448,425
|
$ |
1,478,000
|
$ |
73,750
|
$ |
5,000
|
$ |
1,399,250
|
$ |
1.02
|
||||||||||||||
Remaining
|
-
|
$ |
3,522,000
|
-
|
-
|
-
|
|||||||||||||||||||
Total
Facility
|
-
|
$ |
5,000,000
|
-
|
-
|
-
|
|||||||||||||||||||
Years
ending December 31,
|
Amounts
|
|||
2007
|
$ |
227,082
|
||
2008
|
219,471
|
|||
2009
|
214,015
|
|||
2010
|
219,907
|
|||
2011
|
105,710
|
|||
Total
minimum lease payments
|
$ |
986,185
|
Date
|
Type
|
Months
|
Cost
|
Monthly
Payment
|
Balance
at
December
31
|
||||||||||||
March
2006
|
Laboratory
Equipment
|
60
|
$ |
134,200
|
$ |
2,692
|
$ |
117,117
|
|||||||||
August
2006
|
Laboratory
Equipment
|
60
|
48,200
|
1,200
|
43,724
|
||||||||||||
August
2006
|
Laboratory
Equipment
|
60
|
98,400
|
2,366
|
90,140
|
||||||||||||
August
2006
|
Laboratory
Equipment
|
60
|
101,057
|
2,316
|
89,630
|
||||||||||||
August
2006
|
Laboratory
Equipment
|
60
|
100,200
|
2,105
|
86,740
|
||||||||||||
November
2006
|
Laboratory
Equipment
|
60
|
19,900
|
434
|
19,348
|
||||||||||||
November
2006
|
Computer
Equipment
|
60
|
9,700
|
228
|
9,366
|
||||||||||||
December
2006
|
Computer
Equipment
|
48
|
19,292
|
549
|
17,742
|
||||||||||||
December
2006
|
Computer
Equipment
|
48
|
25,308
|
718
|
24,003
|
||||||||||||
December
2006
|
Office
Equipment
|
60
|
46,100
|
994
|
45,567
|
||||||||||||
Total
|
$ |
602,357
|
$ |
13,602
|
$ |
543,377
|
Years
ending December 31,
|
Amounts
|
|||
2007
|
$ |
163,219
|
||
2008
|
163,219
|
|||
2009
|
163,219
|
|||
2010
|
161,951
|
|||
2011
|
89,582
|
|||
Total
future minimum lease payments
|
741,190
|
|||
Less
amount representing interest
|
197,813
|
|||
Present
value of future minimum lease payments
|
543,377
|
|||
Less
current maturities
|
94,430
|
|||
Obligations
under capital leases – long term
|
$ |
448,947
|
|
1.
|
Recognized
financial assets and financial liabilities
except:
|
|
a.
|
An
investment in a subsidiary that the entity is required to
consolidate
|
|
b.
|
An
interest in a variable interest entity that the entity is required
to
consolidate
|
|
c.
|
Employers’
and plans’ obligations (or assets representing net over funded positions)
for pension benefits, other postretirement benefits (including health
care
and life insurance benefits), postemployment benefits, employee stock
option and stock purchase plans, and other forms of deferred compensation
arrangements.
|
|
d.
|
Financial
assets and financial liabilities recognized under leases as defined
in
FASB Statement No. 13, Accounting for
Leases.
|
|
e.
|
Deposit
liabilities, withdrawable on demand, of banks, savings and loan
associations, credit unions, and other similar depository
institutions
|
|
f.
|
Financial
instruments that are, in whole or in part, classified by the issuer
as a
component of shareholder’s equity (including “temporary equity”). An
example is a convertible debt security with a noncontingent beneficial
conversion feature.
|
|
2.
|
Firm
commitments that would otherwise not be recognized at inception
and that
involve only financial instruments
|
|
3.
|
Nonfinancial
insurance contracts and warranties that the insurer can settle by
paying a
third party to provide those goods or
services
|
|
4.
|
Host
financial instruments resulting from separation of an embedded
nonfinancial derivative instrument from a nonfinancial hybrid
instrument.
|
|
1.
|
May
be applied instrument by instrument, with a few exceptions, such
as
investments otherwise accounted for by the equity
method
|
|
2.
|
Is
irrevocable (unless a new election date
occurs)
|
|
3.
|
Is
applied only to entire instruments and not to portions of
instruments.
|
|
a.
|
Requires
an entity to recognize a servicing asset or servicing liability each
time
it undertakes an obligation to service a financial asset
by entering into a servicing
contract.
|
|
b.
|
Requires
all separately recognized servicing assets and servicing liabilities
to be
initially measured at fair value, if
practicable.
|
|
c.
|
Permits
an entity to choose “Amortization method” or “Fair value measurement
method” for each class of separately recognized servicing assets and
servicing liabilities.
|
|
d.
|
At
its initial adoption, permits a one-time reclassification of
available-for-sale securities to trading securities by entities with
recognized servicing rights, without calling into question the treatment
of other available-for-sale securities under Statement 115, provided
that
the available-for-sale securities are identified in some manner as
offsetting the entity’s exposure to changes in fair value of servicing
assets or servicing liabilities that a servicer elects to subsequently
measure at fair value.
|
|
e.
|
Requires
separate presentation of servicing assets and servicing liabilities
subsequently measured at fair value in the statement of financial
position
and additional disclosures for all separately recognized servicing
assets
and servicing liabilities.
|
|
a.
|
Permits
fair value remeasurement for any hybrid financial instrument that
contains
an embedded derivative that otherwise would require
bifurcation
|
|
b.
|
Clarifies
which interest-only strips and principal-only strips are not subject
to
the requirements of Statement 133
|
|
c.
|
Establishes
a requirement to evaluate interests in securitized financial assets
to
identify interests that are freestanding derivatives or that are
hybrid
financial instruments that contain an embedded derivative requiring
bifurcation
|
|
d.
|
Clarifies
that concentrations of credit risk in the form of subordination are
not
embedded derivatives
|
|
e.
|
Amends
Statement 140 to eliminate the prohibition on a qualifying special-purpose
entity from holding a derivative financial instrument that pertains
to a
beneficial interest other than another derivative financial
instrument.
|
2005
|
||||
Net
loss:
|
||||
As
reported
|
$ | (997,160 | ) | |
Pro
forma
|
$ | (1,022,550 | ) |
Loss
per share:
|
||||
As
reported
|
$ | (0.04 | ) | |
Pro
forma
|
$ | (0.05 | ) |
Number
|
Weighted
Average
|
|||||||
Of
Shares
|
Exercise
Price
|
|||||||
Outstanding
at December 31, 2004
|
882,329
|
$ |
0.16
|
|||||
Granted
|
1,442,235
|
0.27
|
||||||
Exercised
|
(42,235 | ) |
0.00
|
|||||
Canceled
|
(482,329 | ) |
0.09
|
|||||
Outstanding
at December 31, 2005
|
1,800,000
|
0.27
|
||||||
Granted
|
1,010,397
|
0.69
|
||||||
Exercised
|
(211,814 | ) |
0.31
|
|||||
Canceled
|
(481,916 | ) |
0.41
|
|||||
Outstanding
at December 31, 2006
|
2,116,667
|
0.43
|
||||||
Exercisable
at December 31, 2006
|
1,155,166
|
$ |
0.28
|
Weighted
Average
|
||||||||||||||||||
Exercise
Price
|
Number
Outstanding
|
Remaining
Contractual
Life
(in years)
|
Options
Exercisable
|
Weighted
Average
Exercise
Price
|
||||||||||||||
$ |
0.00-0.30
|
1,289,000
|
7.9
|
1,032,500
|
$ |
0.25
|
||||||||||||
$ |
0.31-0.46
|
188,417
|
7.4
|
73,916
|
$ |
0.34
|
||||||||||||
$ |
0.47-0.71
|
406,250
|
9.5
|
28,750
|
$ |
0.62
|
||||||||||||
$ |
0.72-1.08
|
85,000
|
9.7
|
0
|
$ |
0.00
|
||||||||||||
$ |
1.09-1.64
|
148,000
|
9.9
|
20,000
|
$ |
1.30
|
||||||||||||
2,116,667
|
1,155,166
|
Report
of Independent Registered Public Accounting Firm.
|
47
|
|
Consolidated
Balance Sheet as of December 31, 2006.
|
48
|
|
Consolidated
Statements of Operations for the years ended December 31, 2006
and
2005.
|
49
|
|
Consolidated
Statements of Stockholders’ Equity for the years
ended December 31, 2006 and 2005.
|
50
|
|
Consolidated
Statements of Cash Flows for the years ended December
31, 2006 and 2005.
|
51
|
|
Notes
to Consolidated Financial Statements.
|
52
|
ASSETS
|
||||
CURRENT
ASSETS:
|
||||
Cash
and cash equivalents
|
$ |
126,266
|
||
Accounts
receivable (net of allowance for doubtful accounts of
$103,463)
|
1,549,758
|
|||
Inventories
|
117,362
|
|||
Other
current assets
|
102,172
|
|||
Total
current assets
|
1,895,558
|
|||
FURNITURE
AND EQUIPMENT (net of accumulated depreciation of
$494,942)
|
1,202,487
|
|||
OTHER
ASSETS
|
33,903
|
|||
TOTAL
ASSETS
|
$ |
3,131,948
|
||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||
CURRENT
LIABILITIES:
|
||||
Accounts
payable
|
$ |
697,754
|
||
Accrued
compensation
|
133,490
|
|||
Accrued
expenses and other liabilities
|
67,098
|
|||
Due
to affiliates (net of discount of
$39,285)
|
1,635,715
|
|||
Short-term
portion of equipment capital leases
|
94,430
|
|||
Total
current liabilities
|
2,628,487
|
|||
LONG
TERM LIABILITIES:
|
||||
Long-term
portion of equipment capital leases
|
448,947
|
|||
TOTAL
LIABILITIES
|
3,077,434
|
|||
STOCKHOLDERS’
EQUITY:
|
||||
Common
stock, $.001 par value, (100,000,000 shares authorized;
27,061,476
|
||||
shares
issued and outstanding)
|
27,061
|
|||
Additional
paid-in capital
|
11,300,135
|
|||
Deferred
stock compensation
|
(122,623 | ) | ||
Accumulated
deficit
|
(11,150,059 | ) | ||
Total stockholders’ equity
|
54,514
|
|||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$ |
3,131,948
|
2006
|
2005
|
|||||||
NET
REVENUE
|
$ |
6,475,996
|
$ |
1,885,324
|
||||
COST
OF REVENUE
|
2,759,190
|
1,132,671
|
||||||
GROSS
MARGIN
|
3,716,806
|
752,653
|
||||||
OTHER
OPERATING EXPENSE
|
||||||||
General
and administrative
|
3,576,812
|
1,553,017
|
||||||
OTHER
(INCOME)/EXPENSE:
|
||||||||
Other
income
|
(55,970 | ) | (42 | ) | ||||
Interest
expense
|
325,625
|
196,838
|
||||||
Other
(income)/expense – net
|
269,655
|
196,796
|
||||||
NET
LOSS
|
$ | (129,661 | ) | $ | (997,160 | ) | ||
NET
LOSS PER SHARE - Basic
and Diluted
|
$ | (0.00 | ) | $ | (0.04 | ) | ||
WEIGHTED
AVERAGE NUMBER
OF
SHARES OUTSTANDING – Basic and Diluted
|
26,166,031
|
22,264,435
|
||||||
Common
|
Common
|
Additional
|
Deferred
|
|||||||||||||||||||||
Stock
|
Stock
|
Paid-In
|
Stock
|
Accumulated
|
||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Compensation
|
Deficit
|
Total
|
|||||||||||||||||||
Balances,
December 31, 2004
|
21,539,416
|
$ |
21,539
|
$ |
9,603,664
|
$ | (28,620 | ) | $ | (10,023,238 | ) | $ | (426,655 | ) | ||||||||||
Common
Stock issuances
|
1,237,103
|
1,237
|
394,763
|
-
|
-
|
396,000
|
||||||||||||||||||
Transaction
fees and expenses
|
-
|
-
|
(191,160 | ) |
-
|
-
|
(191,160 | ) | ||||||||||||||||
Options
issued to Scientific Advisory Board members
|
-
|
-
|
-
|
2,953
|
-
|
2,953
|
||||||||||||||||||
Value
of non-qualified stock options
|
-
|
-
|
5,638
|
(5,638 | ) |
-
|
-
|
|||||||||||||||||
Warrants
issued for services
|
-
|
-
|
187,722
|
-
|
-
|
187,722
|
||||||||||||||||||
Stock
issued for services
|
60,235
|
60
|
15,475
|
-
|
-
|
15,535
|
||||||||||||||||||
Deferred
stock compensation related to warrants issued for services
|
-
|
-
|
(10,794 | ) |
10,794
|
-
|
-
|
|||||||||||||||||
Amortization
of deferred stock compensation
|
-
|
-
|
-
|
17,826
|
-
|
17,826
|
||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
(997,160 | ) | (997,160 | ) | ||||||||||||||||
Balances,
December 31, 2005
|
22,836,754
|
22,836
|
10,005,308
|
(2,685 | ) | (11,020,398 | ) | (994,939 | ) | |||||||||||||||
Common
Stock issuances for cash
|