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Share Name | Share Symbol | Market | Type |
---|---|---|---|
GenMark Diagnostics Inc | NASDAQ:GNMK | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 24.05 | 23.92 | 24.39 | 0 | 01:00:00 |
|
|
|
x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
¨
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
|
Delaware
|
27-2053069
|
(State or other jurisdiction of
incorporation or organization)
|
(I.R.S. Employer
Identification No.)
|
|
|
5964 La Place Court
Carlsbad, California
|
92008-8829
|
(Address of principal executive offices)
|
(Zip code)
|
|
Large accelerated filer
|
¨
|
|
Accelerated filer
|
x
|
Non-accelerated filer
|
¨
|
(Do not check if a smaller reporting company)
|
Smaller reporting company
|
¨
|
Emerging growth company
|
¨
|
|
|
|
|
|
|
Page
|
PART I. FINANCIAL INFORMATION
|
|
|
Item 1.
|
||
Item 2.
|
||
Item 3.
|
||
Item 4.
|
||
PART II. OTHER INFORMATION
|
|
|
Item 1.
|
||
Item 1A.
|
||
Item 2.
|
||
Item 3.
|
||
Item 4.
|
||
Item 5.
|
||
Item 6.
|
|
March 31,
2017 |
|
December 31,
2016 |
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
13,178
|
|
|
$
|
15,959
|
|
Marketable securities
|
11,007
|
|
|
25,607
|
|
||
Accounts receivable, net of allowances of $2,749 and $2,740, respectively
|
7,487
|
|
|
9,048
|
|
||
Inventories
|
9,019
|
|
|
6,633
|
|
||
Prepaid expenses and other current assets
|
1,419
|
|
|
1,202
|
|
||
Total current assets
|
42,110
|
|
|
58,449
|
|
||
Property and equipment, net
|
18,482
|
|
|
18,268
|
|
||
Intangible assets, net
|
2,546
|
|
|
2,670
|
|
||
Restricted cash
|
758
|
|
|
758
|
|
||
Other long-term assets
|
179
|
|
|
179
|
|
||
Total assets
|
$
|
64,075
|
|
|
$
|
80,324
|
|
Current liabilities
|
|
|
|
||||
Accounts payable
|
$
|
5,696
|
|
|
$
|
8,703
|
|
Accrued compensation
|
4,510
|
|
|
5,650
|
|
||
Loan payable
|
7,685
|
|
|
7,935
|
|
||
Other current liabilities
|
3,159
|
|
|
4,133
|
|
||
Total current liabilities
|
21,050
|
|
|
26,421
|
|
||
Long-term liabilities
|
|
|
|
||||
Deferred rent
|
3,524
|
|
|
3,652
|
|
||
Long-term debt
|
12,261
|
|
|
11,880
|
|
||
Other non-current liabilities
|
186
|
|
|
220
|
|
||
Total liabilities
|
37,021
|
|
|
42,173
|
|
||
Stockholders’ equity
|
|
|
|
||||
Preferred stock, $0.0001 par value; 5,000 authorized, none issued
|
—
|
|
|
—
|
|
||
Common stock, $0.0001 par value; 100,000 authorized; 47,084 and 46,554 shares issued and outstanding as of March 31, 2017 and December 31, 2016, respectively
|
5
|
|
|
4
|
|
||
Additional paid-in capital
|
396,217
|
|
|
393,322
|
|
||
Accumulated deficit
|
(369,188)
|
|
|
(355,270)
|
|
||
Accumulated other comprehensive income
|
20
|
|
|
95
|
|
||
Total stockholders’ equity
|
27,054
|
|
|
38,151
|
|
||
Total liabilities and stockholders’ equity
|
$
|
64,075
|
|
|
$
|
80,324
|
|
|
Three Months Ended
|
||||||
|
March 31,
|
||||||
|
2017
|
|
2016
|
||||
Revenue
|
|
|
|
||||
Product revenue
|
$
|
12,470
|
|
|
$
|
10,959
|
|
License and other revenue
|
65
|
|
|
105
|
|
||
Total revenue
|
12,535
|
|
|
11,064
|
|
||
Cost of revenue
|
6,352
|
|
|
4,375
|
|
||
Gross profit
|
6,183
|
|
|
6,689
|
|
||
Operating expenses
|
|
|
|
||||
Sales and marketing
|
4,693
|
|
|
3,709
|
|
||
General and administrative
|
4,011
|
|
|
3,419
|
|
||
Research and development
|
11,035
|
|
|
12,269
|
|
||
Total operating expenses
|
19,739
|
|
|
19,397
|
|
||
Loss from operations
|
(13,556)
|
|
|
(12,708)
|
|
||
Other income (expense)
|
|
|
|
||||
Interest income
|
52
|
|
|
29
|
|
||
Interest expense
|
(507
|
)
|
|
(277
|
)
|
||
Other income
|
95
|
|
|
33
|
|
||
Total other expense
|
(360)
|
|
|
(215)
|
|
||
Loss before provision for income taxes
|
(13,916)
|
|
|
(12,923)
|
|
||
Income tax expense
|
1
|
|
|
35
|
|
||
Net loss
|
$
|
(13,917
|
)
|
|
$
|
(12,958
|
)
|
Net loss per share, basic and diluted
|
$
|
(0.30
|
)
|
|
$
|
(0.30
|
)
|
Weighted average number of shares outstanding, basic and diluted
|
46,846
|
|
|
42,672
|
|
||
Other comprehensive loss
|
|
|
|
||||
Net loss
|
$
|
(13,917
|
)
|
|
$
|
(12,958
|
)
|
Foreign currency translation adjustments
|
91
|
|
|
47
|
|
||
Net unrealized losses on marketable securities, net of tax
|
(16
|
)
|
|
(17
|
)
|
||
Comprehensive loss
|
$
|
(13,842
|
)
|
|
$
|
(12,928
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Operating activities
|
|
|
|
||||
Net loss
|
$
|
(13,917
|
)
|
|
$
|
(12,958
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
1,217
|
|
|
900
|
|
||
Amortization of premiums on investments
|
19
|
|
|
16
|
|
||
Amortization of deferred debt issuance costs
|
151
|
|
|
92
|
|
||
Stock-based compensation
|
2,808
|
|
|
2,402
|
|
||
Provision for bad debt
|
9
|
|
|
29
|
|
||
Non-cash inventory adjustments
|
317
|
|
|
75
|
|
||
Other non-cash adjustments
|
(85
|
)
|
|
(49
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
1,558
|
|
|
1,385
|
|
||
Inventories
|
(3,118
|
)
|
|
501
|
|
||
Prepaid expenses and other assets
|
(216
|
)
|
|
—
|
|
||
Accounts payable
|
(2,821
|
)
|
|
617
|
|
||
Accrued compensation
|
(1,144
|
)
|
|
989
|
|
||
Other liabilities
|
(343
|
)
|
|
(42
|
)
|
||
Net cash used in operating activities
|
(15,565
|
)
|
|
(6,043
|
)
|
||
Investing activities
|
|
|
|
||||
Payments for intellectual property licenses
|
—
|
|
|
(800
|
)
|
||
Purchases of property and equipment
|
(1,888
|
)
|
|
(966
|
)
|
||
Proceeds from sales of marketable securities
|
13,896
|
|
|
—
|
|
||
Maturities of marketable securities
|
700
|
|
|
—
|
|
||
Net cash provided by (used in) investing activities
|
12,708
|
|
|
(1,766
|
)
|
||
Financing activities
|
|
|
|
||||
Principal repayment of borrowings
|
(6
|
)
|
|
(5
|
)
|
||
Costs associated with debt issuance
|
(20
|
)
|
|
(10
|
)
|
||
Proceeds from stock option exercises
|
88
|
|
|
345
|
|
||
Net cash provided by financing activities
|
62
|
|
|
330
|
|
||
Effect of exchange rate changes on cash
|
14
|
|
|
7
|
|
||
Net decrease in cash and cash equivalents
|
(2,781
|
)
|
|
(7,472
|
)
|
||
Cash and cash equivalents at beginning of period
|
15,959
|
|
|
35,385
|
|
||
Cash and cash equivalents at end of period
|
$
|
13,178
|
|
|
$
|
27,913
|
|
Non-cash investing and financing activities
|
|
|
|
||||
Transfer of instruments from (to) property and equipment into inventory
|
$
|
(415
|
)
|
|
$
|
38
|
|
Property and equipment costs included in accounts payable
|
$
|
183
|
|
|
$
|
285
|
|
Supplemental cash flow disclosures
|
|
|
|
||||
Cash paid for income taxes, net
|
$
|
5
|
|
|
$
|
13
|
|
Cash received for interest
|
$
|
108
|
|
|
$
|
21
|
|
Cash paid for interest
|
$
|
347
|
|
|
$
|
184
|
|
Machinery and laboratory equipment
|
3 - 5 years
|
Instruments
|
4 - 5 years
|
Office equipment
|
3 - 7 years
|
Leasehold improvements
|
over the shorter of the remaining life of the lease or the useful economic life of the asset
|
|
Number of
Shares
|
|
Weighted Average Exercise Price
|
|||
Outstanding at December 31, 2016
|
2,569,550
|
|
|
$
|
9.53
|
|
Granted
|
—
|
|
|
—
|
|
|
Exercised
|
(16,471)
|
|
|
5.33
|
|
|
Cancelled
|
(3,258)
|
|
|
11.94
|
|
|
Outstanding at March 31, 2017
|
2,549,821
|
|
|
9.56
|
|
|
Vested and expected to vest at March 31, 2017
|
2,490,813
|
|
|
9.50
|
|
|
Exercisable at March 31, 2017
|
2,016,369
|
|
|
$
|
8.93
|
|
|
Restricted Stock Awards
|
|
Restricted Stock Units
|
||||||||||
|
Number of
Shares
|
|
Weighted
Average
Grant Date
Fair Value
|
|
Number of
Shares
|
|
Weighted
Average
Grant Date
Fair Value
|
||||||
Unvested at December 31, 2016
|
156
|
|
|
$
|
11.19
|
|
|
1,766,123
|
|
|
$
|
7.18
|
|
Granted
|
—
|
|
|
—
|
|
|
1,028,884
|
|
|
10.68
|
|
||
Vested
|
(156)
|
|
|
11.19
|
|
|
(320,081)
|
|
|
6.00
|
|
||
Cancelled
|
—
|
|
|
—
|
|
|
(20,766)
|
|
|
8.47
|
|
||
Unvested at March 31, 2017
|
—
|
|
|
$
|
—
|
|
|
2,454,160
|
|
|
$
|
8.79
|
|
|
Market-Based Stock Units
|
|||||
|
Number of
Shares
|
|
Weighted
Average
Grant Date
Fair Value
|
|||
Unvested at December 31, 2016
|
222,773
|
|
|
$
|
7.34
|
|
Target units granted
|
243,561
|
|
|
13.82
|
|
|
Vested
|
—
|
|
|
—
|
|
|
Cancelled
|
—
|
|
|
—
|
|
|
Unvested at March 31, 2017
|
466,334
|
|
|
$
|
10.53
|
|
|
Three Months Ended
|
||||||
|
March 31,
|
||||||
|
2017
|
|
2016
|
||||
Expected volatility
|
54
|
%
|
|
49
|
%
|
||
Risk-free interest rate
|
1.50
|
%
|
|
0.90
|
%
|
||
Expected dividend
|
—
|
%
|
|
—
|
%
|
||
Weighted average fair value
|
$
|
13.82
|
|
|
$
|
4.94
|
|
|
Three Months Ended March 31,
|
||
|
2017
|
|
2016
|
Options outstanding to purchase common stock
|
2,550
|
|
2,875
|
Other unvested equity awards
|
2,931
|
|
2,390
|
Total
|
5,481
|
|
5,265
|
|
March 31, 2017
|
|
December 31, 2016
|
||||
Raw materials
|
$
|
2,589
|
|
|
$
|
2,171
|
|
Work-in-process
|
2,929
|
|
|
1,488
|
|
||
Finished goods
|
3,501
|
|
|
2,974
|
|
||
Total inventories
|
$
|
9,019
|
|
|
$
|
6,633
|
|
|
March 31, 2017
|
|
December 31, 2016
|
||||
Property and equipment — at cost:
|
|
|
|
||||
Machinery and laboratory equipment
|
$
|
10,245
|
|
|
$
|
10,145
|
|
Instruments
|
10,662
|
|
|
9,869
|
|
||
Office equipment
|
1,742
|
|
|
1,714
|
|
||
Leasehold improvements
|
10,318
|
|
|
10,100
|
|
||
Total property and equipment — at cost
|
32,967
|
|
|
31,828
|
|
||
Less: accumulated depreciation
|
(14,485
|
)
|
|
(13,560
|
)
|
||
Property and equipment, net
|
$
|
18,482
|
|
|
$
|
18,268
|
|
|
March 31, 2017
|
|
December 31, 2016
|
||||||||||||||||||||
|
Gross Carrying Amount
|
|
Accumulated Amortization
|
|
Net Carrying Amount
|
|
Gross Carrying Amount
|
|
Accumulated Amortization
|
|
Net Carrying Amount
|
||||||||||||
Licensed intellectual property
|
$
|
4,250
|
|
|
$
|
(1,704
|
)
|
|
$
|
2,546
|
|
|
$
|
4,250
|
|
|
$
|
(1,580
|
)
|
|
$
|
2,670
|
|
Fiscal Years Ending
|
|
Future Amortization Expense
|
||
Remaining in 2017
|
|
$
|
373
|
|
2018
|
|
497
|
|
|
2019
|
|
497
|
|
|
2020
|
|
497
|
|
|
2021
|
|
497
|
|
|
Thereafter
|
|
185
|
|
|
Total
|
|
$
|
2,546
|
|
|
|
March 31, 2017
|
|
December 31, 2016
|
||||
Term Loans
|
|
|
|
|
||||
Term Loan A - 6.9% principal
|
|
$
|
10,000
|
|
|
$
|
10,000
|
|
Term Loan B - 6.9% principal
|
|
10,000
|
|
|
10,000
|
|
||
Final fee obligation
|
|
878
|
|
|
400
|
|
||
Unamortized issuance costs
|
|
(932
|
)
|
|
(585
|
)
|
||
Total debt, net
|
|
19,946
|
|
|
19,815
|
|
||
Current portion of long-term debt
|
|
(7,685
|
)
|
|
(7,935
|
)
|
||
Long-term debt
|
|
$
|
12,261
|
|
|
$
|
11,880
|
|
|
March 31, 2017
|
||||||||||||||
|
Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
Total
|
||||||||
Money market funds (cash equivalents)
|
$
|
242
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
242
|
|
Corporate notes and bonds
|
—
|
|
|
9,007
|
|
|
—
|
|
|
9,007
|
|
||||
U.S. government and agency securities
|
—
|
|
|
1,500
|
|
|
—
|
|
|
1,500
|
|
||||
Commercial paper
|
—
|
|
|
500
|
|
|
—
|
|
|
500
|
|
||||
Total
|
$
|
242
|
|
|
$
|
11,007
|
|
|
$
|
—
|
|
|
$
|
11,249
|
|
|
|
|
|
|
|
|
|
||||||||
|
December 31, 2016
|
||||||||||||||
|
Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
Total
|
||||||||
Money market funds (cash equivalents)
|
$
|
556
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
556
|
|
Corporate notes and bonds
|
—
|
|
|
18,821
|
|
|
—
|
|
|
18,821
|
|
||||
U.S. government and agency securities
|
—
|
|
|
3,503
|
|
|
—
|
|
|
3,503
|
|
||||
Commercial paper
|
—
|
|
|
3,283
|
|
|
—
|
|
|
3,283
|
|
||||
Total
|
$
|
556
|
|
|
$
|
25,607
|
|
|
$
|
—
|
|
|
$
|
26,163
|
|
March 31, 2017
|
|
Amortized Cost
|
|
Gross Unrealized Gains
|
|
Gross Unrealized Losses
|
|
Estimated Fair Value
|
||||||||
Corporate notes and bonds
|
|
$
|
9,017
|
|
|
$
|
—
|
|
|
$
|
(10
|
)
|
|
$
|
9,007
|
|
U.S. government and agency securities
|
|
1,502
|
|
|
—
|
|
|
(2
|
)
|
|
1,500
|
|
||||
Commercial paper
|
|
500
|
|
|
—
|
|
|
—
|
|
|
500
|
|
||||
Total
|
|
$
|
11,019
|
|
|
$
|
—
|
|
|
$
|
(12
|
)
|
|
$
|
11,007
|
|
|
|
|
|
|
|
|
|
|
||||||||
December 31, 2016
|
|
Amortized Cost
|
|
Gross Unrealized Gains
|
|
Gross Unrealized Losses
|
|
Estimated Fair Value
|
||||||||
Corporate notes and bonds
|
|
$
|
18,846
|
|
|
$
|
—
|
|
|
$
|
(25
|
)
|
|
$
|
18,821
|
|
U.S. government and agency securities
|
|
3,506
|
|
|
—
|
|
|
(3
|
)
|
|
3,503
|
|
||||
Commercial paper
|
|
3,283
|
|
|
—
|
|
|
—
|
|
|
3,283
|
|
||||
Total
|
|
$
|
25,635
|
|
|
$
|
—
|
|
|
$
|
(28
|
)
|
|
$
|
25,607
|
|
|
Amortized Cost
|
|
Estimated Fair Value
|
||||
Due in one year or less
|
$
|
11,019
|
|
|
$
|
11,007
|
|
Due after one year through two years
|
—
|
|
|
—
|
|
||
Total
|
$
|
11,019
|
|
|
$
|
11,007
|
|
|
Three Months Ended March 31,
|
|||||||||||||
|
2017
|
|
2016
|
|
$ Change
|
|
% Change
|
|||||||
|
(dollars in thousands)
|
|
|
|
|
|||||||||
Revenue
|
$
|
12,535
|
|
|
$
|
11,064
|
|
|
$
|
1,471
|
|
|
13
|
%
|
|
Three Months Ended March 31,
|
|||||||||||||
|
2017
|
|
2016
|
|
$ Change
|
|
% Change
|
|||||||
|
(dollars in thousands)
|
|
|
|
|
|||||||||
Cost of Revenue
|
$
|
6,352
|
|
|
$
|
4,375
|
|
|
$
|
1,977
|
|
|
45
|
%
|
Gross Profit
|
$
|
6,183
|
|
|
$
|
6,689
|
|
|
$
|
(506
|
)
|
|
(8
|
)%
|
|
Three Months Ended March 31,
|
|||||||||||||
|
2017
|
|
2016
|
|
$ Change
|
|
% Change
|
|||||||
|
(dollars in thousands)
|
|
|
|
|
|||||||||
Sales and Marketing
|
$
|
4,693
|
|
|
$
|
3,709
|
|
|
$
|
984
|
|
|
27
|
%
|
|
Three Months Ended March 31,
|
|||||||||||||
|
2017
|
|
2016
|
|
$ Change
|
|
% Change
|
|||||||
|
(dollars in thousands)
|
|
|
|
|
|||||||||
General and Administrative
|
$
|
4,011
|
|
|
$
|
3,419
|
|
|
$
|
592
|
|
|
17
|
%
|
|
Three Months Ended March 31,
|
|||||||||||||
|
2017
|
|
2016
|
|
$ Change
|
|
% Change
|
|||||||
|
(dollars in thousands)
|
|
|
|
|
|||||||||
Research and Development
|
$
|
11,035
|
|
|
$
|
12,269
|
|
|
$
|
(1,234
|
)
|
|
(10
|
)%
|
|
Three Months Ended March 31,
|
|||||||||||||
|
2017
|
|
2016
|
|
$ Change
|
|
% Change
|
|||||||
|
(dollars in thousands)
|
|
|
|
|
|||||||||
Other Income (Expense)
|
$
|
(360
|
)
|
|
$
|
(215
|
)
|
|
$
|
(145
|
)
|
|
67
|
%
|
|
Three Months Ended March 31,
|
|||||||||||||
|
2017
|
|
2016
|
|
$ Change
|
|
% Change
|
|||||||
|
(dollars in thousands)
|
|
|
|
|
|||||||||
Income tax expense (benefit)
|
$
|
1
|
|
|
$
|
35
|
|
|
$
|
(34
|
)
|
|
(97
|
)%
|
|
March 31,
|
||||||
Three months ended (in thousands):
|
2017
|
|
2016
|
||||
Net cash used in operating activities
|
$
|
(15,565
|
)
|
|
$
|
(6,043
|
)
|
Net cash used in investing activities
|
12,708
|
|
|
(1,766
|
)
|
||
Net cash provided by financing activities
|
62
|
|
|
330
|
|
||
Effect of exchange rate on cash
|
14
|
|
|
7
|
|
||
Net increase (decrease) in cash and cash equivalents
|
$
|
(2,781
|
)
|
|
$
|
(7,472
|
)
|
|
|
|
GENMARK DIAGNOSTICS, INC.
|
|
|
|
|
|
|
|
|
Date:
|
May 2, 2017
|
By:
|
/s/ HANY MASSARANY
|
|
|
|
Hany Massarany
|
|
|
|
President and Chief Executive Officer
|
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
|
|
|
|
|
Date:
|
May 2, 2017
|
By:
|
/s/ SCOTT MENDEL
|
|
|
|
Scott Mendel
|
|
|
|
Chief Financial Officer
|
|
|
|
(Principal Financial and Accounting Officer)
|
|
|
|
|
Exhibit
|
Description
|
3.1
|
Certificate of Incorporation (incorporated by reference to our Registration Statement on Form S-1 (File No. 333-165562) filed with the Commission on March 19, 2010).
|
3.2
|
Amended and Restated Bylaws (incorporated by reference to our Current Report on Form 8-K filed with the SEC on October 31, 2014).
|
10.1
|
The GenMark Diagnostics Inc. 2017 Bonus Plan (incorporated by reference to our Current Report on Form 8-K filed with the SEC on February 24, 2017).†
|
10.2
|
Second Amendment to Loan and Security Agreement dated as of February 27, 2017 by and among GenMark Diagnostics, Inc., as borrower, its domestic subsidiaries, as guarantors, Solar Senior Capital Ltd., as administrative and collateral agent, and certain other financial institutions as lenders.+
|
31.1
|
Certification of Principal Executive Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended.
|
31.2
|
Certification of Principal Financial Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended.
|
32.1
|
Certification of Principal Executive Officer and Principal Financial Officer Required Under Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. §1350.
|
101.INS
|
XBRL Instance Document.
|
101.SCH
|
XBRL Taxonomy Extension Schema Document.
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document.
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
1 Year GenMark Diagnostics Chart |
1 Month GenMark Diagnostics Chart |
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