Highmark Health’s VITAL Innovation Program testing benefits of Biocept’s liquid biopsy platform for improving outcomes and lowering costs of treatment for patients with non-small cell lung cancer

Allegheny Health Network’s Cancer Institute spear­heading the eval­u­a­tion

PITTSBURGH and SAN DIEGO (August 23, 2018) – Highmark Health announced today that through its VITAL Innovation Program, it is testing Biocept, Inc.’s Target Selector™ liquid biopsy plat­form designed to help oncol­o­gists improve the diag­nosis and treat­ment of patients with non-​small cell lung cancer (NSCLC). The goals of the collab­o­ra­tion are to improve health outcomes by using liquid biopsy to more rapidly assess a patient’s mole­c­ular status and select appro­priate therapy, while reducing the overall cost of care.

A test-​and-​learn plat­form, the unique VITAL program lever­ages Highmark Health’s posi­tion as the nation’s second largest inte­grated delivery and financing system. VITAL facil­i­tates real-​world testing of early-​stage health inno­va­tions, producing evidence related to patient expe­ri­ence, and care and cost outcomes. The evidence may accel­erate an innovation’s coverage and utiliza­tion by health plans and care delivery systems, fast-​tracking the solu­tion to patients and supporting swifter market­place adop­tion.

More than 100 patients of Highmark Health-​affiliated Allegheny Health Network [AHN] Cancer Institute will partic­i­pate in the eval­u­a­tion of the Biocept (NASDAQ: BIOC) plat­form as a method of improving the mole­c­ular profiling rate of advanced NSCLC. During the eval­u­a­tion, the Biocept plat­form will mole­c­u­larly profile the liquid biop­sies of newly diag­nosed, treatment-​naïve advanced NSCLC patients and NSCLC patients progressing after initial therapy. These patients will also receive tissue biopsy as part of the eval­u­a­tion.

Lung cancer is the leading cause of cancer death for both men and women in the United States, with an esti­mated 155,870 deaths in 2017.1 The median overall survival for patients with advanced NSCLC is approx­i­mately one year, with the five-​year survival rate for metastatic lung cancer at 5%.2 However, 17 – 27% of NSCLC patients harbor mole­c­ular alter­ations that can be treated with specific FDA-​approved targeted ther­a­pies. In order to realize the full poten­tial of these targeted ther­a­pies, oncol­o­gists require timely and accu­rate mole­c­ular char­ac­ter­i­za­tion of a patient’s cancer for selec­tion of the best possible therapy, with some of the treat­ment regi­mens extending median patient survival times from one to two and one-​half years.3 – 7

Despite these advances, a large percentage of patients may not undergo mole­c­ular profiling due to a number of prac­tical constraints. Chief among these is the avail­ability of tissue for mole­c­ular testing. Lung cancers are often diffi­cult to biopsy because of their loca­tion within what is often diseased lung tissue of elderly patients. Needle biopsy is the most common tech­nique but often does not yield enough tissue for mole­c­ular testing. Performing a second biopsy is a way of reme­dying this situ­a­tion, but these proce­dures can add to risk and cost. The VITAL test will study the oppor­tu­nity for Biocept’s liquid biopsy from a simple blood draw to provide an effec­tive solu­tion that can lower cost, provide addi­tional infor­ma­tion to help oncol­o­gists precisely target ther­a­pies, and achieve better outcomes.

The diag­nosis, treat­ment and care of cancer patients is among Highmark Health’s chief prior­i­ties and a focus of the VITAL Innovation Program,” said Sarah Ahmad, senior vice pres­i­dent of inno­va­tion and trans­for­ma­tion strategy for Highmark Health. We look forward to eval­u­ating the ways in which Biocept’s tech­nology could help trans­form the care of patients chal­lenged by lung cancer.” 

This project directly supports the Allegheny Health Network Cancer Institute’s mission to advance best prac­tices, including diag­nosis and treat­ment of all cancers, and to help remove any barriers to patients’ access to the best care that’s avail­able,” said Gene Finley, MD, deputy director of Allegheny Health Network Medical Oncology and lead inves­ti­gator on this project. We believe that imple­menting Biocept liquid biop­sies could provide AHN clin­i­cians with more accu­rate knowl­edge about their patients’ disease, allowing us to imple­ment more effec­tive and better targeted treat­ment strate­gies.”

This collab­o­ra­tion with the VITAL Innovation Program and Allegheny Health Network reflects Biocept’s role as a leader in the liquid biopsy field and repre­sents an impor­tant move­ment towards improving care for cancer patients,” said Michael Nall, Biocept’s pres­i­dent and chief exec­u­tive officer. We hope to further build the body of evidence supporting our Target Selector™ platform’s ability to help physi­cians rapidly obtain the action­able infor­ma­tion they need to design person­al­ized treat­ment plans for their patients.”

VITAL’s eval­u­a­tion of Biocept’s Target Selector™ liquid biopsy plat­form will occur for a period of 12 months, concluding in August of 2019.

About Highmark Health

Highmark Health, a Pittsburgh, PA-​based company, that, together with its subsidiaries and affil­i­ates collec­tively employ more than 40,000 people and serve millions of Americans across the country, is the second largest inte­grated health care delivery and financing network in the nation based on revenue. Highmark Health is the parent company of Highmark Inc., Allegheny Health Network, and HM Health Solutions. Highmark Inc. and its subsidiaries and affil­i­ates provide health insur­ance to nearly 5 million members in Pennsylvania, West Virginia, and Delaware as well as dental insur­ance, vision care and related health prod­ucts through a national network of diver­si­fied busi­nesses that include United Concordia Companies, HM Insurance Group, and Visionworks. Allegheny Health Network is the parent company of an inte­grated delivery network that includes eight hospi­tals, more than 2,400 affil­i­ated physi­cians, ambu­la­tory surgery centers, an employed physi­cian orga­ni­za­tion, home and community-​based health services, a research insti­tute, a group purchasing orga­ni­za­tion, and health and well­ness pavil­ions in western Pennsylvania. HM Health Solutions focuses on meeting the infor­ma­tion tech­nology plat­form and other busi­ness needs of the Highmark Health enter­prise as well as unaf­fil­i­ated health insur­ance plans by providing proven busi­ness processes, expert knowl­edge and inte­grated cloud-​based plat­forms. To learn more, please visit www​.high​markhealth​.org. For infor­ma­tion specific to the VITAL Innovation Program, please visit www​.vital​in​no​va​tion​.com.

About Allegheny Health Network

Allegheny Health Network, a Highmark Health company, is an inte­grated health­care delivery system serving the greater Western Pennsylvania region. The Network is composed of eight hospi­tals, including Allegheny General Hospital, its flag­ship acad­emic medical center in Pittsburgh, Allegheny Valley Hospital in Natrona Heights, Canonsburg Hospital in Canonsburg, Forbes Hospital in Monroeville, Jefferson Hospital in Jefferson Hills, Saint Vincent Hospital in Erie, West Penn Hospital in Pittsburgh and Westfield Memorial Hospital in Westfield, NY. The Network provides patients with access to a complete spec­trum of advanced medical services, including nation­ally recog­nized programs for primary and emer­gency care, cardio­vas­cular disease, cancer care, ortho­pedic surgery, neurology and neuro­surgery, women’s health, diabetes and more. It also is home to a compre­hen­sive research insti­tute; Health + Wellness Pavilions; an employed physi­cian orga­ni­za­tion, home and commu­nity based health services and a group purchasing orga­ni­za­tion. The Network employs approx­i­mately 19,000 people, has more than 2,400 physi­cians on its medical staff and serves as a clin­ical campus for Drexel University College of Medicine, Temple University School of Medicine, and the Lake Erie College of Osteopathic Medicine. To learn more, please visit www​.AHN​.org.

About Biocept

Biocept, Inc. (NASDAQ: BIOC) is a mole­c­ular diag­nos­tics company with commer­cial­ized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma. The Company lever­ages its propri­etary liquid biopsy tech­nology to provide physi­cians with clin­i­cally action­able infor­ma­tion for treating and moni­toring patients diag­nosed with cancer. Biocept’s patented Target Selector™ liquid biopsy tech­nology plat­form captures and analyzes tumor-​associated mole­c­ular markers in both circu­lating tumor cells (CTCs) and in circu­lating tumor DNA (ctDNA). With thou­sands of tests performed, the plat­form has demon­strated the ability to iden­tify cancer muta­tions and alter­ations to inform physi­cians about a patient’s disease and ther­a­peutic options. For addi­tional infor­ma­tion, please visit www​.biocept​.com.

Forward-​Looking Statements Disclaimer Statement

This news release contains forward-​looking state­ments that are based upon current expec­ta­tions or beliefs, as well as a number of assump­tions about future events. Although Biocept believes that the expec­ta­tions reflected in the forward-​looking state­ments and the assump­tions upon which they are based are reason­able, Biocept can give no assur­ance that such expec­ta­tions and assump­tions will prove to be correct. Forward-​looking state­ments are gener­ally iden­ti­fi­able by the use of words like may,” will,” should,” could,” expect,” antic­i­pate,” esti­mate,” believe,” intend” or project,” or the nega­tive of these words or other vari­a­tions on these words or compa­rable termi­nology. To the extent that state­ments in this news release are not strictly histor­ical, including, without limi­ta­tion, state­ments as to Biocept’s ability to improve the outcomes of cancer patients, the utility and cost effec­tive­ness of Biocept’s tests, and Biocept’s ability to further vali­date its liquid biopsy tech­nology, such state­ments are forward-​looking, and are made pursuant to the safe harbor provi­sions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-​looking state­ments, as these state­ments are subject to numerous risk factors as set forth in Biocept’s Securities and Exchange Commission (SEC) filings. The effects of such risks and uncer­tain­ties could cause actual results to differ mate­ri­ally from the forward-​looking state­ments contained in this news release. Biocept does not plan to update any such forward-​looking state­ments and expressly disclaims any duty to update the infor­ma­tion contained in this press release except as required by law.

Contacts
Janice Maszle
Highmark Health
janice.​maszle@​highmarkhealth.​org
412.544.7643
412.217.7970 (cell)

Biocept Media Contact
Colleen Murphy
Trevelino/​Keller
cmurphy@​trevelinokeller.​com
404.214.0722, Ext. 109

References:

[1] Siegel RL, Miller KD, Jemal A. Cancer statis­tics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7 – 30.
[2] Kim TE, Murren JR. Therapy for stage IIIB and stage IV non-​small cell lung cancer. Clin Chest Med. 2002 Mar; 23(1):209 – 224.
[3] Sequist LV, et al. Phase III study of afatinib or cisplatin plus peme­trexed in patients with metastatic lung adeno­car­ci­noma with EGFR muta­tions. J Clin Oncol. 2013 Sep 20; 31(27):3327 – 3334.
[4] Fukuoka M, et al. Biomarker analyses and final overall survival results from a phase III, random­ized, open-​label, first-​line study of gefi­tinib versus carboplatin/​paclitaxel in clin­i­cally selected patients with advanced non-​small-​cell lung cancer in Asia (IPASS). J Clin Oncol. 2011 Jul 20; 29(21):2866 – 2874.
[5] Rosell R, et al. Erlotinib versus stan­dard chemotherapy as first-​line treat­ment for European patients with advanced EGFR mutation-​positive non-​small-​cell lung cancer (EURTAC): a multi­centre, open-​label, randomised phase 3 trial. Lancet Oncol. 2012 Mar; 13(3):239 – 246.
[6] Maemondo M, et al. Gefitinib or chemotherapy for non-​small-​cell lung cancer with mutated EGFR. N Engl J Med. 2010 Jun 24; 362(25):2380 – 2388.
[7] Chih-​Hsin Yang J et al Afatinib versus cisplatin based chemotherapy for EGFR muta­tion posi­tive lung adeno­car­ci­noma (LUX-​Lung 3 and LUX-​Lung 6): analysis of overall survival from two random­ized phase 3 trials Lancet Oncology 2015;16 141 – 151