PerkinElmer Provides an Update on Valencia Branch Laboratory’s Accreditation Process

February 22, 2021 8:30 AM EST

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WALTHAM, Mass.--(BUSINESS WIRE)-- PerkinElmer, Inc., (NYSE: PKI) a global leader committed to innovating for a healthier world, today provided an update on the COVID-19 Valencia Branch Laboratory’s (VBL) accreditation process. The VBL is operated by PerkinElmer in partnership with the California Department of Public Health (CDPH). The VBL started operations on November 1, 2020, and Laboratory Field Services (LFS) performed its routine inspection on December 8, 2020.

The VBL received LFS’s routine inspection report on February 19, 2021, and PerkinElmer’s response is due by March 1, 2021. During the months of December and January, the VBL supplied additional information at LFS’s request. Upon review, it appears that LFS had not yet incorporated this extensive information into its routine inspection report. PerkinElmer believes that the deficiencies identified by LFS have long since been resolved.

Also on February 19, the VBL had an inspection for accreditation with the College of American Pathologists (CAP), a third-party independent entity, and the Company fully expects a prompt and positive response. The VBL is seeking accreditation from the CAP so that Californians have no doubt about the quality of the services at the laboratory. Once accredited, the VBL will join PerkinElmer’s labs in Pennsylvania, India and China that already have the CAP accreditation. The CAP is the leading organization of board-certified pathologists, serving patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide.

Dedicated individuals at PerkinElmer and CDPH have worked extremely hard and hand-in-hand since September to open the VBL and in parallel ramp up the capacity to meet the State’s testing needs. By November 1, the State had built the VBL infrastructure out to BSL-3 standards, and PerkinElmer had installed its high throughput COVID-19 testing automated solution. Today, the VBL has nearly 600 employees and the capacity for 100,000 tests per day. PerkinElmer has operated the VBL in full transparency with CDPH and the California Health and Human Services Agency.

“PerkinElmer is proud of this public-private collaboration with California to bring critical testing to the community. We uphold the highest quality and safety standards across all of our operations, and we have already addressed the issues that emerged in the early days since the Valencia testing site was established, despite just receiving the formal report from the December inspection,” said Prahlad Singh, PerkinElmer’s president and chief executive officer. “Furthermore, with our initial CAP inspection last week, I am confident in our ongoing efforts to operate a best-in-class laboratory for the benefit of California residents.”

“California opened the Valencia Branch Laboratory in collaboration with PerkinElmer to expand laboratory testing capacity and ensure access to testing for neighborhoods that were disproportionately affected by the pandemic at a time when testing was relatively scarce and supply chains were strained,” said California Health and Human Services Secretary Dr. Mark Ghaly. “We take these findings seriously and are committed to working with PerkinElmer to ensure we provide the best possible results for the people of California.”

The Company is extremely proud of being able to increase testing availability for Californians who might otherwise lack access, including communities at high risk for contracting COVID-19 such as essential workers, those in congregate care settings, and communities of color. The VBL has enabled testing of more than 1.5 million samples from a network of more than 1,500 community-based specimen collection sites in churches, schools, clinics, employers, and community-based organizations.

Recent media reporting on the VBL’s operations has unfortunately caused confusion about laboratory practices and the accreditation process, and sown concern about the reliability of testing performed at the VBL. That concern is misplaced; out of all samples received, the VBL has issued corrected reports for approximately 60 out of more than 1.5 million samples processed. PerkinElmer looks forward to working in partnership with CDPH through the processes with LFS and the CAP to give Californians comfort that while extraordinarily complex, the VBL is also operating at the highest standards.

About PerkinElmer

PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $3.8 billion in 2020, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.

Factors Affecting Future Performance

This press release contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to estimates and projections of future earnings per share, cash flow and revenue growth and other financial results, developments relating to our customers and end-markets, and plans concerning business development opportunities, acquisitions and divestitures. Words such as "believes," "intends," "anticipates," "plans," "expects," "projects," "forecasts," "will" and similar expressions, and references to guidance, are intended to identify forward-looking statements. Such statements are based on management's current assumptions and expectations and no assurances can be given that our assumptions or expectations will prove to be correct. A number of important risk factors could cause actual results to differ materially from the results described, implied or projected in any forward-looking statements. These factors include, without limitation: (1) markets into which we sell our products declining or not growing as anticipated; (2) the effect of the COVID-19 pandemic on our sales and operations; (3) fluctuations in the global economic and political environments; (4) our failure to introduce new products in a timely manner; (5) our ability to execute acquisitions and license technologies, or to successfully integrate acquired businesses and licensed technologies into our existing business or to make them profitable, or successfully divest businesses; (6) our failure to adequately protect our intellectual property; (7) the loss of any of our licenses or licensed rights; (8) our ability to compete effectively; (9) fluctuation in our quarterly operating results and our ability to adjust our operations to address unexpected changes; (10) significant disruption in third-party package delivery and import/export services or significant increases in prices for those services; (11) disruptions in the supply of raw materials and supplies; (12) the manufacture and sale of products exposing us to product liability claims; (13) our failure to maintain compliance with applicable government regulations; (14) regulatory changes; (15) our failure to comply with healthcare industry regulations; (16) economic, political and other risks associated with foreign operations; (17) our ability to retain key personnel; (18) significant disruption in our information technology systems, or cybercrime; (19) our ability to obtain future financing; (20) restrictions in our credit agreements; (21) discontinuation or replacement of LIBOR; (22) the United Kingdom’s withdrawal from the European Union; (23) our ability to realize the full value of our intangible assets; (24) significant fluctuations in our stock price; (25) reduction or elimination of dividends on our common stock; and (26) other factors which we describe under the caption "Risk Factors" in our most recent quarterly report on Form 10-Q and in our other filings with the Securities and Exchange Commission. We disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Investor Relations:
PerkinElmer, Inc.
Bryan Kipp, 781-663-5583
bryan.kipp@perkinelmer.com

Media Relations:
PerkinElmer, Inc.
Chet Murray, 781-462-5126
chet.murray@perkinelmer.com

Source: PerkinElmer, Inc.



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