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Gen-Probe Reports Strong Financial Results for Fourth Quarter and Full Year 2007
Date:2/13/2008

- Company Posts Fourth Quarter EPS of $0.37, Up 16% - - For Full Year 2007, Strong Operating Earnings and Tax Benefits Drive EPS

Up 41%; Total Revenues and Product Sales Both Grow 14% - - In 2008, Gen-Probe Expects Highest Pre-Tax Income Growth in Four Years,

Driving Anticipated EPS of $1.64 to $1.72 -

SAN DIEGO, Feb. 13 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) today reported strong financial results for the fourth quarter and full year ended December 31, 2007, including quarterly earnings per share (EPS) of $0.37.

"Gen-Probe once again posted good financial results in the fourth quarter of 2007, led by the continued growth of our clinical diagnostics business," said Henry L. Nordhoff, the Company's chairman and chief executive officer. "In addition, our fourth quarter performance completed an excellent 2007 in which strong operating earnings and tax benefits combined to drive EPS up 41%."

In the fourth quarter of 2007, product sales were $92.4 million, compared to $85.5 million in the prior year period, an increase of 8%. Total revenues for the fourth quarter of 2007 were $98.9 million, compared to $91.1 million in the prior year period, an increase of 9%. Net income in the fourth quarter of 2007 was $20.4 million, compared to $17.1 million in the prior year period, an increase of 19%. EPS in the fourth quarter of 2007 were $0.37, compared to $0.32 in the prior year period, an increase of 16%. In this press release, all per share amounts are calculated on a fully diluted basis, and all results are presented in US GAAP.

For the full year 2007, product sales were $370.9 million, compared to $325.3 million in the prior year, an increase of 14%. Total rROCLEIX are trademarks of Novartis. All other trademarks are the property of their owners.

Caution Regarding Forward-Looking Statements

Any statements in this press release about our expectations, beliefs, plans, objectives, assumptions or future events or performance, including those under the heading "Initial 2008 Financial Guidance," are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as believe, will, expect, anticipate, estimate, intend, plan and would. For example, statements concerning Gen-Probe's financial condition, possible or expected results of operations, updated financial guidance, regulatory approvals, future milestone payments, growth opportunities, and plans and objectives of management are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied. Some of these risks, uncertainties and assumptions include but are not limited to: (i) the risk that we may not achieve our expected 2008 growth, revenue, earnings or other financial targets, (ii) the risk that we may not earn or receive milestone payments from our collaborators, including Novartis and 3M, (iii) the possibility that the market for the sale of our new products, such as our TIGRIS system, APTIMA Combo 2 assay, PROCLEIX ULTRIO assay, PROGENSA PCA3 assay and industrial products, may not develop as expected, (iv) the enhancement of existing products and the development of new products, including products, if any, to be developed under our industrial collaborations, may not proceed as planned, (v) the risk that new products or indications, such as the HBV screening claim for our PROCLEIX ULTRIO assay in the United States, may not be approved by regulatory authorities or commercially available in the time frame we anticipate, or at all, (vi) we may not be able to compete effectively, (vii) we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations or customer contracts, (viii) we are dependent on Novartis, Siemens (as assignee of Bayer) and other third parties for the distribution of some of our products, (ix) we are dependent on a small number of customers, contract manufacturers and single source suppliers of raw materials, (x) changes in third-party reimbursement policies regarding our products could adversely affect sales of our products, (xi) changes in government regulation affecting our diagnostic products could harm our sales and increase our development costs, (xii) the risk that our intellectual property may be infringed by third parties or invalidated, and (xiii) our involvement in patent and other intellectual property and commercial litigation could be expensive and could divert management's attention. The foregoing list sets forth some, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements. For additional information about risks and uncertainties we face and a discussion of our financial statements and footnotes, see documents we file with the SEC, including our most recent annual report on Form 10-K and all subsequent periodic reports. We assume no obligation and expressly disclaim any duty to update forward-looking statements to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.

Gen-Probe Incorporated

Consolidated Balance Sheets

(In thousands, except share and per share data)

December 31, December 31,

2007 2006

Assets

Current assets:

Cash and cash equivalents $75,963 $87,905

Short-term investments 357,531 202,008

Trade accounts receivable, net of

allowance for doubtful accounts of

$719 and $670 at December 31, 2007

and December 31, 2006, respectively 32,678 25,880

Accounts receivable - other 11,044 1,646

Inventories 48,540 52,056

Deferred income tax - short term 8,825 7,247

Prepaid income tax 2,390 -

Prepaid expenses 17,505 11,362

Other current assets 4,402 2,583

Total current assets 558,878 390,687

Property, plant and equipment, net 129,493 134,614

Capitalized software 15,923 18,437

Goodwill 18,621 18,621

Deferred income tax - long term 7,942 2,064

License, manufacturing access fees and

other assets 58,196 59,416

Total assets $789,053 $623,839

Liabilities and stockholders' equity

Current liabilities:

Accounts payable $11,777 $13,586

Accrued salaries and employee benefits 20,997 16,723

Other accrued expenses 4,014 3,320

Income tax payable 846 14,075

Deferred revenue 2,836 921

Total current liabilities 40,470 48,625

Non-current income tax payable 3,958 -

Deferred income tax - long term 75 -

Deferred revenue 4,607 3,667

Deferred rent 10 128

Deferred compensation plan liabilities 1,893 1,211

Commitments and contingencies

Stockholders' equity:

Preferred stock, $.0001 par value per share,

20,000,000 shares authorized,

none issued and outstanding - -

Common stock, $.0001 par value per share;

200,000,000 shares authorized,

53,916,298 and 52,233,656 shares issued and

outstanding at December 31, 2007 and

December 31, 2006, respectively 5 5

Additional paid-in capital 415,229 334,184

Accumulated other comprehensive income (loss) 1,604 (5)

Retained earnings 321,202 236,024

Total stockholders' equity 738,040 570,208

Total liabilities and stockholders' equity $789,053 $623,839

Gen-Probe Incorporated

Consolidated Statements of Income

(In thousands, except per share data)

Three Months Ended Twelve Months Ended

December 31, December 31,

2007 2006 2007 2006

Revenues:

Product sales $92,426 $85,496 $370,877 $325,307

Collaborative research revenue 5,380 1,194 16,619 15,937

Royalty and license revenue 1,143 4,369 15,518 13,520

Total revenues 98,949 91,059 403,014 354,764

Operating expenses:

Cost of product sales 28,493 27,675 119,641 103,882

Research and development 24,331 20,712 97,144 84,545

Marketing and sales 11,348 9,563 39,928 37,096

General and administrative 12,265 10,832 47,007 44,936

Total operating expenses 76,437 68,782 303,720 270,459

Income from operations 22,512 22,277 99,294 84,305

Interest income 3,837 2,755 12,772 8,301

Interest expense - (1) 30 (63)

Other income / expense (144) 854 (499) 451

Total other income, net 3,693 3,608 12,303 8,689

Income before income tax 26,205 25,885 111,597 92,994

Income tax expense 5,793 8,751 25,457 33,496

Net income $20,412 $17,134 $86,140 $59,498

Net income per share:

Basic $0.38 $0.33 $1.63 $1.15

Diluted $0.37 $0.32 $1.58 $1.12

Weighted average

shares outstanding:

Basic 53,769 51,835 52,975 51,538

Diluted 55,310 53,305 54,522 53,101

Gen-Probe Incorporated

Consolidated Statements of Cash Flows

(In thousands)

Twelve Months Ended

December 31,

2007 2006

Operating activities:

Net income $86,140 $59,498

Adjustments to reconcile net income to net

cash provided by operating activities:

Depreciation and amortization 34,159 27,496

Amortization of premiums on investments, net

of accretion of discounts 4,576 3,204

Stock-based compensation charges 19,651 23,723

Stock option income tax benefits 2,596 191

Excess tax benefit from employee stock options (14,606) (9,187)

Loss on disposal of property and equipment 201 99

Impairment of fixed assets 502 -

Changes in assets and liabilities:

Accounts receivable (16,180) 6,544

Inventories 3,588 (7,798)

Prepaid expenses (6,141) (595)

Other current assets (2,307) 1,683

Other long-term assets (1,131) (2,147)

Accounts payable (1,818) (471)

Accrued salaries and employee benefits 4,273 2,063

Other accrued expenses 679 (27)

Income tax payable (397) 9,970

Deferred revenue 2,855 (7,516)

Deferred income tax (7,621) (6,559)

Deferred rent (118) (112)

Deferred compensation plan liabilities 683 961

Net cash provided by operating activities 109,584 101,020

Investing activities:

Proceeds from sales and maturities of

short-term investments 140,988 132,657

Purchases of short-term investments (298,824) (149,012)

Purchases of property, plant and equipment (23,096) (50,760)

Purchase of intangible assets, including

license and manufacturing access fees (2,213) (11,460)

Other assets (279) (633)

Net cash used in investing activities (183,424) (79,208)

Financing activities:

Excess tax benefit from employee stock options 14,606 9,187

Repurchase and retirement of restricted stock

for payment of taxes (1,474) (429)

Proceeds from issuance of common stock 48,680 24,395

Net cash provided by financing activities 61,812 33,153

Effect of exchange rate changes on cash and

cash equivalents 86 612

Net (decrease) increase in cash and cash

equivalents (11,942) 55,577

Cash and cash equivalents at the beginning

of year 87,905 32,328

Cash and cash equivalents at the end of year $75,963 $87,905

Contact:

Michael Watts

Sr. director, investor relations and

corporate communications

858-410-8673

evenues for 2007 were $403.0 million, compared to $354.8 million in the prior year, an increase of 14%. Net income for 2007 was $86.1 million, compared to $59.5 million in the prior year, an increase of 45%. EPS in 2007 were $1.58, compared to $1.12 in the prior year, an increase of 41%.

Gen-Probe's net income and EPS in the fourth quarter of 2007 benefited from an income tax rate of approximately 22% that resulted primarily from the completion of an audit of the Company's 2003 and 2004 California state income tax returns and additional research and development credits earned in 2007. Net income and EPS for the full year 2007 benefited from an income tax rate of approximately 23% that resulted primarily from the items noted above and the completion of an audit of the Company's 2003 and 2004 federal income tax returns (benefit recorded in the second quarter).

Detailed Results

Gen-Probe's clinical diagnostics sales in the fourth quarter of 2007 were again led by the APTIMA Combo 2(R) assay, an amplified nucleic acid test (NAT) for simultaneously detecting Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). Sales of this assay grew based on market share gains on both the Company's semi-automated instrument platform and on the high-throughput, fully automated TIGRIS(R) system. Revenue from the PACE(R) product line, the Company's non-amplified tests for Chlamydia and gonorrhea, declined in the fourth quarter compared to the prior year period, in line with Gen-Probe's expectations.

In blood screening, product sales in the fourth quarter of 2007 benefited from continued international expansion, and from higher pricing associated with US commercial sales of the PROCLEIX(R) WNV (West Nile virus) assay on the TIGRIS system. Gen-Probe's blood screening sales in the fourth quarter of 2007 were negatively affected by the timing of shipments. The Company's blood screening products are marketed worldwide by Chiron, a business unit of Novartis Vaccines and Diagnostics.

Product sales were, in millions:

Three Months Ended Dec. 31, Year Ended Dec. 31,

2007 2006 Increase 2007 2006 Increase

Clinical diagnostics $49.7 $45.4 10 % $199.2 $171.2 16 %

Blood screening $42.7 $40.1 6 % $171.7 $154.1 11 %

Total product sales $92.4 $85.5 8 % $370.9 $325.3 14 %

Collaborative research revenues in the fourth quarter of 2007 were $5.4 million, compared to $1.2 million in the prior year period. This increase resulted from several factors, including:

-- Research reimbursement and milestone payments from 3M related to the

companies' collaboration to develop rapid tests for

healthcare-associated infections.

-- Research reimbursement and milestone payments from 3M related to the

companies' collaboration for food testing, which was terminated in the

fourth quarter.

-- Funds received from the US Department of Defense for prostate cancer

research.

For the full year 2007, collaborative research revenues were $16.6 million, compared to $15.9 million in the prior year, an increase of 4% that resulted primarily from the factors described above. These increases were partially offset by the reclassification of revenue associated with investigational use of the PROCLEIX WNV assay. Beginning in the third quarter of 2006, the Company began recording all revenue associated with this assay in product sales, rather than in collaborative research revenues. The assay was approved by the US Food and Drug Administration (FDA) for use on Gen-Probe's enhanced semi-automated instrument system (eSAS) in December of 2005, and for use on the TIGRIS system in March of 2007.

Royalty and license revenues for the fourth quarter of 2007 were $1.1 million, compared to $4.4 million in the prior year period, a decrease of 75%. This decrease resulted primarily from the final installment of license revenue under the Company's collaboration with bioMerieux, which was recognized in the prior year period. For the full year 2007, royalty and license revenues were $15.5 million, compared to $13.5 million in the prior year, an increase of 15% that resulted primarily from $10.3 million of royalty revenue that was recorded in the first quarter of 2007 associated with the successful settlement of Gen-Probe's patent infringement claims against Bayer HealthCare (now Siemens Healthcare Diagnostics).

Gross margin on product sales in the fourth quarter of 2007 was 69.2%, compared to 67.6% in the prior year period. This increase resulted primarily from reduced sales of lower-margin instrumentation compared to the prior year period. For the full year 2007, gross margin on product sales was 67.7%, compared to 68.1% in the prior year.

Research and development (R&D) expenses in the fourth quarter of 2007 were $24.3 million, compared to $20.7 million in the prior year period, an increase of 17%. This increase resulted primarily from increased labor costs and the timing of major R&D projects. These projects include assays for human papillomavirus (HPV) and healthcare-associated infections, a fully automated instrument system for low- and mid-volume laboratory customers, and the post-marketing studies for the PROCLEIX ULTRIO(R) assay in the United States. For the full year 2007, R&D expenses were $97.1 million, compared to $84.5 million in the prior year, an increase of 15% that was due primarily to the factors described above.

Marketing and sales expenses in the fourth quarter of 2007 were $11.3 million, compared to $9.6 million in the prior year period, an increase of 18%. This increase resulted primarily from European market development efforts related to the Company's investigational APTIMA HPV assay. For the full year 2007, marketing and sales expenses were $39.9 million, compared to $37.1 million in the prior year, an increase of 8% that resulted primarily from European market development efforts.

General and administrative (G&A) expenses in the fourth quarter of 2007 were $12.3 million, compared to $10.8 million in the prior year period, an increase of 14% that resulted primarily from increased compensation costs. For the full year 2007, G&A expenses were $47.0 million, compared to $44.9 million in the prior year, an increase of 5%.

Gen-Probe continues to have a strong balance sheet. As of December 31, 2007, the Company had $433.5 million of cash, cash equivalents and short-term investments, and no debt. In 2007, Gen-Probe generated net cash of $109.6 million from its operating activities, higher than the Company's net income of $86.1 million.

Initial 2008 Financial Guidance

"We expect 2008 to be another year of double-digit revenue growth and high profitability for Gen-Probe, even as we continue to invest in attractive R&D projects to drive our long-term prospects," said Herm Rosenman, the Company's senior vice president of finance and chief financial officer. "Although we expect our tax rate to increase to a normalized level in 2008, our guidance anticipates pre-tax income growing at its fastest pace since 2004."

For the full year 2008, Gen-Probe expects the following on a GAAP basis:

-- Total revenues of $443 million to $453 million, representing growth of

10% to 12% over 2007. Product sales growth is expected to be led by

continued market share gains for the APTIMA Combo 2 assay, by

commercial pricing of the PROCLEIX WNV assay on the TIGRIS system in

the United States, and by ongoing international expansion of the

PROCLEIX ULTRIO assay on the TIGRIS system. Although Gen-Probe

believes the US Food and Drug Administration (FDA) will approve a

hepatitis B "screening claim" for the PROCLEIX ULTRIO assay during

2008, the Company has not included any US product sales revenue for

this assay in its guidance, based on the time needed to commercialize

the new indication. Non-product revenues in 2008 are expected to

benefit from an approximately $16 million final payment associated

with the successful settlement of Gen-Probe's patent infringement

claims against Bayer HealthCare (now Siemens Healthcare Diagnostics),

and from a $10 million milestone the Company expects to earn from

Novartis if and when the PROCLEIX ULTRIO assay is fully approved on

the TIGRIS system in the United States.

-- Product gross margins approximating 68% to 70% of product sales. This

improvement over 2007 is expected to result primarily from continued

conversion of PACE customers to the APTIMA Combo 2 assay, from

commercial pricing of the PROCLEIX WNV assay on the TIGRIS system, and

from the leverage inherent in rising manufacturing volumes. These

benefits are expected to be partially offset by continued growth of

the PROCLEIX ULTRIO assay in developing markets, where pricing is less

robust.

-- R&D expenses approximating 23% to 24% of total revenues, down slightly

from 2007 as a percentage of revenues. The Company's highest priority

R&D projects for 2008 include the post-marketing HBV yield studies for

the PROCLEIX ULTRIO assay in the United States, development of the

APTIMA human papillomavirus assay, and development of the Panther

instrument platform for low- and mid-volume laboratory customers.

-- Marketing and sales expenses approximating 9% to 10% of total

revenues, similar to 2007 as a percentage of revenues.

-- G&A expenses approximating 11% of total revenues, down slightly

from 2007 as a percentage of revenues.

-- EPS of between $1.64 and $1.72, based on approximately 56 million

fully diluted shares outstanding for the year and a tax rate of 35%.

Recent Events

-- PROCLEIX ULTRIO Post-Marketing Study. Gen-Probe believes the Company

has met its goal of identifying a second case of hepatitis B "yield"

in the post-marketing study for the PROCLEIX ULTRIO assay. Yield is

defined as an HBV-infected blood donation that was intercepted by the

PROCLEIX ULTRIO assay, but that was initially negative based on

traditional serology tests. To date, participating blood banks have

screened approximately 500,000 blood donations in the study. The FDA

has approved the PROCLEIX ULTRIO assay to screen donated blood for

HIV-1 and hepatitis C virus (HCV), but not to screen for HBV, as the

initial clinical studies were not designed to, and did not,

demonstrate HBV yield. Within a month, Gen-Probe intends to submit a

supplemental Biologics License Application (BLA) to the US Food and

Drug Administration in hopes of gaining a donor screening claim for

HBV.

-- Carl Hull Named President and COO. On February 11, Gen-Probe

announced that Carl Hull was named the Company's president and chief

operating officer, effective March 1, 2008. Mr. Hull joined Gen-Probe

in February of 2007 as executive vice president and chief operating

officer. He oversees the Company's major operating functions,

including research and development, manufacturing, and sales and

marketing.

-- New Operations Executive. On November 19, Gen-Probe announced that

Jorgine Ellerbrock joined the Company as senior vice president,

operations. She joined the Company from Invitrogen Corporation, where

she had been vice president, operations, since 2004, most recently for

the Molecular Biology Business.

-- 3M Food Collaboration. On November 8, Gen-Probe announced that 3M

informed the Company it no longer intends to fund the companies'

collaboration to develop rapid molecular assays for the food testing

industry. The collaboration has since been formally terminated.

Despite the termination, Gen-Probe received milestone payments of

$2 million in the fourth quarter of 2007 associated with achieving

technological feasibility for potential food testing assays.

Gen-Probe retains the rights to commercialize these assays.

-- First MilliPROBE(TM) Test. On January 8, Millipore and Gen-Probe

announced the launch of the first product from their collaboration to

create faster, sensitive, more robust tests for detecting contaminants

in pharmaceutical and biotechnology manufacturing processes. The

MilliPROBE system is the first solution of its kind for

biopharmaceutical manufacturing. It combines Millipore's leading,

industry-accepted sample prep methodologies with Gen-Probe's advanced,

proven nucleic acid technologies to deliver both speed and sensitivity

in one microbial screening tool. The MilliPROBE system uses Real-Time

Transcription-Mediated Amplification (RT TMA) technology to detect

targeted microbial contamination within hours compared to the days or

weeks usually required to generate results using traditional

culture-based methods. The collaboration's first MilliPROBE assay

targets the bacterium Pseudomonas aeruginosa and is designed as an

in-process, early warning system to provide faster, more effective

detection of the bacterium in purified water used during drug

production.

-- Purchase of Blood Screening Manufacturing Plant. On February 1,

Gen-Probe purchased for $15.7 million its blood screening

manufacturing facility located in Rancho Bernardo, California. The

Company had leased the 94,000-square-feet facility since late 1997.

The transaction is expected to have an immaterial effect on

Gen-Probe's income statement in 2008, but is expected to be accretive

to earnings over the long term, based on rent increases that would

have been associated with renewing the Company's lease. "The purchase

of our state-of-the-art blood screening manufacturing facility on

attractive financial terms reflects our long-term commitment to

providing innovative nucleic acid tests that safeguard the world's

supply of donated blood," said Mr. Hull.

Webcast Conference Call

A live webcast of Gen-Probe's fourth quarter 2007 conference call for investors can be accessed at http://www.gen-probe.com beginning at 4:30 p.m. Eastern Time today. The webcast will be archived for at least 90 days. A telephone replay of the call also will be available for approximately 24 hours. The replay number is (800) 308-7858 for domestic callers and (402) 220-3841 for international callers.

About Gen-Probe

Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs) that are used primarily to diagnose human diseases and screen donated human blood. Gen-Probe has 25 years of NAT expertise, and received the 2004 National Medal of Technology, America's highest honor for technological innovation, for developing NAT assays for blood screening. Gen-Probe is headquartered in San Diego and employs approximately 1,000 people. For more information, go to http://www.gen-probe.com.

Trademarks

APTIMA, APTIMA COMBO 2, PACE and TIGRIS are trademarks of Gen-Probe. ULTRIO and P
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SOURCE Gen-Probe Incorporated
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