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Interpace Biosciences Releases Preliminary Record Second Quarter 2023 Business Results; Updates Status of PancraGEN Reimbursement

Interpace Biosciences Releases Preliminary Record Second Quarter 2023 Business Results; Updates Status of PancraGEN Reimbursement

Interpace Biosciences 發佈了 2023 年第二季度創紀錄的初步業務業績;更新 PancraGen 報銷情況
GlobeNewswire ·  2023/07/10 15:59
  • Q2 Revenue of $11 million; a 49.1% increase year-over-year and 12.2% better than Q1; highest quarter in history
  • 1st Half Revenue $20.9 million; 36.1% improvement over 1st Half 2022
  • Q2 Test volume up 15.2% year-over-year to record levels; 1st Half volume up 16.5% year-over-year
  • Novitas announces that LCD L39365 has been rescinded and will NOT go into effect July 17, 2023
  • 第二季度收入爲1100萬美元;同比增長49.1%,比第一季度增長12.2%;有史以來最高的季度
  • 1st 半年收入 2,090 萬美元;比 1 增長了 36.1%st 2022 年半年
  • 第二季度測試量同比增長15.2%,達到創紀錄的水平;1st 半成交量同比增長16.5%
  • 諾維塔斯 宣佈 LCD L39365 已撤銷,不會於 2023 年 7 月 17 日生效

PARSIPPANY, NJ, July 10, 2023 (GLOBE NEWSWIRE) -- Interpace Biosciences, Inc. ("Interpace" or the "Company") (OTCQX: IDXG) today announced preliminary business results for the second quarter ending June 30, 2023, and provided an update on recent activities. Final Q2 financial results are expected to be released no later than August 11, 2023.

新澤西州帕西帕尼,2023 年 7 月 10 日(GLOBE NEWSWIRE)— Interpace Biosciences, Inc.(“Interpace” 或 “公司”)(OTCQX: IDXG)今天公佈了截至2023年6月30日的第二季度的初步業務業績,並提供了近期活動的最新情況。預計第二季度的最終財務業績將不遲於2023年8月11日發佈。

Second quarter Net Revenue was $11 million, fueled by significant volume growth for ThyGeNEXT + ThyraMIRv2 and PancraGEN. First half revenue was $20.9 million resulting in a 36.1% increase over 2022. Overall, volume grew 15.2% and 16.5% for Q2 and 1st Half YOY, respectively.. The two franchises grew 13.2% and 18.7% for thyroid and pancreatic testing, respectively. Volume and revenue both surpassed the prior records set in Q1 2023. According to Tom Burnell, President and CEO of Interpace, "We continue to be pleased with the adoption and utilization of the Company's molecular diagnostic tests and their role in supporting physicians in the diagnosis and treatment of patients."

第二季度淨收入爲1100萬美元,這得益於ThygeNext的銷量大幅增長 + ThyraMIRv2 和 PancraGen。上半年的收入爲2,090萬美元,比2022年增長了36.1%。總體而言,第二季度和第一季度的銷量增長了15.2%和16.5%st 同比分別爲半年...這兩個特許經營權在甲狀腺和胰腺測試方面分別增長了13.2%和18.7%。銷量和收入均超過了 2023 年第一季度創下的紀錄。Interpace總裁兼首席執行官湯姆·伯內爾表示:“我們仍然對公司分子診斷測試的採用和利用及其在支持醫生診斷和治療患者方面的作用感到滿意。”

On July 6, 2023, Novitas Solutions, Inc. announced that it was rescinding implementation of the Genetic Testing for Oncology LCD (L39365) so that it will not become effective on July 17, 2023. As a result, Interpace is able to continue offering PancraGEN and the related Point2 fluid chemistry tests for amylase, CEA, and glucose.

2023年7月6日,Novitas Solutions, Inc. 宣佈將撤銷腫瘤基因檢測 LCD(L39365)的實施,因此該檢測不會在2023年7月17日生效。因此,Interpace 得以繼續提供 PancraGen 和相關的 Point2 澱粉酶、CEA 和葡萄糖的液體化學測試。

According to Tom Burnell, "We are very pleased that this revised policy decision allows Interpace to continue offering PancraGEN – a widely used molecular test that aids physicians in their diagnosis of pancreatic cancer when first-line tests and procedures are inconclusive." Dr. Burnell further added, "Pancreatic cancer primarily strikes the Medicare-aged population and has the highest mortality rate of all major cancers. This new decision by the Medicare Administrative Contractor (MAC), Novitas Solutions, Inc. allows continued physician access to important molecular insights that can help inform optimal patient management – including the reduction of unnecessary surgeries."

根據湯姆·伯內爾的說法,“我們很高興這項修訂後的政策決定允許Interpace繼續提供PancraGen——這是一種廣泛使用的分子檢測,在一線檢測和手術尚無定論時可以幫助醫生診斷胰腺癌。”伯內爾博士進一步補充說:“胰腺癌主要襲擊醫療保險年齡段的人羣,是所有主要癌症中死亡率最高的。醫療保險管理承包商(MAC)Novitas Solutions, Inc. 的這一新決定使醫生能夠持續獲得重要的分子見解,這些見解有助於爲最佳的患者管理提供信息,包括減少不必要的手術。”

About Interpace Biosciences

關於 Interpace 生物科學

Interpace Biosciences is an emerging leader in enabling personalized medicine, offering specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications.

Interpace Biosciences是實現個性化醫療領域的新興領導者,在治療價值鏈上提供專業服務,從早期診斷和預後規劃到靶向治療應用。

Clinical services, through Interpace Diagnostics, provide clinically useful molecular diagnostic tests and bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. Interpace has five commercialized molecular tests and one test in a clinical evaluation program (CEP): PancraGEN for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; PanDNA, a "molecular only" version of PancraGEN that provides physicians a snapshot of a limited number of factors; ThyGeNEXT for the diagnosis of thyroid cancer from thyroid nodules utilizing a next-generation sequencing assay; ThyraMIRv2, used in combination with ThyGeNEXT, for the diagnosis of thyroid cancer utilizing a proprietary microRNA pairwise expression profiler along with algorithmic classification; and RespriDX, that differentiates lung cancer of primary versus metastatic origin. In addition, BarreGEN, a molecular-based assay that helps resolve the risk of progression of Barrett's Esophagus to esophageal cancer, is currently in a CEP, whereby we gather information from physicians using BarreGEN to assist us in gathering clinical evidence relative to the safety and performance of the test and also providing data that will potentially support payer reimbursement.

臨床服務通過Interpace Diagnostics提供臨床有用的分子診斷測試以及生物信息學和病理學服務,用於評估癌症風險,利用個性化醫療的最新技術來改善患者的診斷和管理。Interpace 有五項商業化分子測試和一項臨床評估計劃 (CEP) 中的一項測試:PancraGen 用於胰腺囊腫引起的胰腺癌的診斷和預後;panDNA,PancraGen 的 “純分子” 版本,可爲醫生提供有限數量因素的快照;ThygeNext 用於利用下一代測序測定法診斷甲狀腺結節引起的甲狀腺癌;ThyraMIRv2,與 ThygeNext 結合使用,用於使用專有的 microRNA 配對錶達譜儀和算法分類來診斷甲狀腺癌;以及 respridX,它區分了原發性肺癌和轉移性肺癌。此外,BarreGen,一種基於分子的測定,有助於解決巴雷特食道發展爲食管癌的風險,目前正在進行CEP,通過CEP,我們從使用BarreGen的醫生那裏收集信息,以幫助我們收集與測試安全性和性能有關的臨床證據,並提供可能支持付款人報銷的數據。

For more information, please visit Interpace Biosciences' website at .

欲瞭解更多信息,請訪問Interpace Biosciences的網站,網址爲。

Forward-looking Statements

前瞻性陳述

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to the Company's future financial and operating performance. The Company has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from those expressed or implied by any forward-looking statements, including, but not limited to, the reimbursement of the Company's tests being subject to review by CMS, the Company's ability to continue to perform, bill and receive reimbursement for our PancraGEN molecular test under the existing local coverage determination ("LCD"), given that such LCD is currently under review by Novitas Solutions, Inc., the Company's Medicare administrative contractor, the possibility that the Company's estimates of future revenue, cash flows and adjusted EBITDA may prove to be materially inaccurate, the Company's history of operating losses, the Company's ability to adequately finance its business and seek alternative sources of financing, the Company's ability to repay borrowings with Comerica Bank and BroadOak, the Company's dependence on sales and reimbursements from its clinical services, the Company's ability to retain or secure reimbursement including its reliance on third parties to process and transmit claims to payers and the adverse impact of any delay, data loss, or other disruption in processing or transmitting such claims, the Company's revenue recognition being based in part on estimates for future collections which estimates may prove to be incorrect, and the possible removal of the Company's common stock from trading on the OTCQX.

本新聞稿包含1933年《證券法》第27A條、1934年《證券交易法》第21E條和1995年《私人證券訴訟改革法》所指的前瞻性陳述,涉及公司未來的財務和經營業績。公司試圖通過術語來識別前瞻性陳述,包括 “相信”、“估計”、“預期”、“預期”、“計劃”、“項目”、“打算”、“潛在”、“可能”、“可能”、“將”、“應該”、“大約” 或其他傳達未來事件或結果不確定性的詞語,以識別這些前瞻性陳述。這些陳述基於當前的預期、假設和不確定性,包括對未來經濟、競爭和市場狀況以及未來業務決策等的判斷,所有這些都很難或不可能準確預測,其中許多都超出了公司的控制範圍。這些陳述還涉及已知和未知的風險、不確定性和其他因素,這些因素可能導致公司的實際業績與任何前瞻性陳述所表達或暗示的業績存在重大差異,包括但不限於有待CMS審查的公司測試的報銷, 該公司的 能夠繼續履行我們的職責、開具賬單並獲得報銷 PancraGen 根據現有的局部覆蓋率測定(“LCD”)進行分子測試,因爲此類液晶屏目前正在審查中 諾維塔斯 該公司的醫療保險管理承包商Solutions, Inc. 公司對未來收入、現金流和調整後息稅折舊攤銷前利潤的估計可能存在重大不準確的可能性、公司的營業虧損歷史、公司爲業務提供充足資金和尋求替代融資來源的能力、公司向Comerica Bank償還借款的能力以及 BroadOa,公司對銷售和臨床服務報銷的依賴,公司保留或獲得報銷的能力,包括依賴第三方處理索賠並將其轉交給付款人,以及處理或傳輸此類索賠的任何延遲、數據丟失或其他中斷的不利影響, 公司的收入確認部分基於對未來收款的估計,這些估計可能被證明是不正確的,以及公司的普通股可能被取消在OTCQX的交易

Additionally, all forward-looking statements are subject to the "Risk Factors" detailed from time to time in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as amended, Current Reports on Form 8-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

此外,所有前瞻性陳述均受公司截至2022年12月31日財年的10-K表年度報告(經修訂)、向美國證券交易委員會提交的8-K表最新報告和10-Q表季度報告中不時詳述的 “風險因素” 的約束。由於這些風險和其他風險、不確定性和假設,不應過度依賴這些前瞻性陳述。此外,這些聲明僅代表截至本新聞稿發佈之日,除非法律要求,否則公司沒有義務出於任何原因公開修改或更新任何前瞻性陳述。

Contacts:

聯繫人:

Investor Relations
Interpace Biosciences, Inc.
(855)-776-6419
Info@Interpace.com

投資者關係
Interpace 生物科學公司
(855) -776-6419
Info@Interpace.com


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